WELCOME, EVERYONE, TO THE 15th
MEETING OF THE BRAIN NEUROETHICS
WORKING GROUP, NEWG FOR SHORT.
I WANT TO ESPECIALLY EXTEND A
WARM WELCOME TO OUR WORKING
GROUP CO-CHAIRS, DOCTORS NINA
FARAHANY AND CHRISTINE GRADY, AS
WELL AS ALL THE MEMBERS OF THE
WORKING GROUP AND OUR INVITED
SPEAKERS AND PANELISTS WHO ARE
JOINING US TODAY.
I'M ANDREA BECKEL-MITCHENER,
DEPUTY DIRECTOR OF NIH BRAIN
INITIATIVE, DESIGNATED FEDERAL
OFFICIAL FOR TODAY'S MEETING.
MOST OF YOU KNOW, THE
NEUROETHICS WORKING GROUP IS NOT
A FORMAL ADVISORY GROUP, LIKE
"BRAIN"'S MULTI-COUNCIL WORKING
GROUP.
THE NEWG IS A WORKING GROUP OF
THE ADVISORY COUNCILS OF THE TEN
NIH INSTITUTES THAT PARTICIPATE
IN THE BRAIN INITIATIVE, AND
NEWG WAS ESTABLISHED BECAUSE OF
THE NEED FOR INPUT ON
NEUROETHICS CONSIDERATIONS
RELATED TO THE RESEARCH
SUPPORTED THROUGH THE BRAIN
INITIATIVE.
SO, THE NEWG WILL DELIBERATE ON
ETHICAL QUESTIONS THAT COME UP
IN THE CONTEXT OF BRAIN
INITIATIVE RESEARCH AND CAN
OFFER POINTS TO CONSIDER.
TODAY WE ONCE AGAIN HAVE A
VIRTUAL MEETING, AND SLIGHTLY
ABRIDGED FORMAT, BUT WE'RE
HOPEFUL WE'LL BE ABLE TO MEET IN
PERSON AGAIN SOON.
WE'LL TODAY HAVE AN UPDATE FROM
THE "BRAIN" DIRECTOR ON THE NIH
BRAIN INITIATIVE, WE'LL BEGIN
WITH THAT, FOLLOWING THAT
SPENDING TIME THINKING ABOUT
HEALTH-RELATED TECHNOLOGIES THAT
AFFECT THE BRAIN.
FIRST BY HEARING ABOUT TWO
RECENT CASE STUDIES, AFTER THE
BREAK WE'LL BE LOOKING FORWARD
TO THE DISCUSSION TO THINK ABOUT
THE STARTING PLACE, IF ANY, FOR
NEWG ENGAGEMENT ON
HEALTH-RELATED APPLICATIONS OF
TECHNOLOGIES THAT MAY AFFECT THE
BRAIN.
AND AS USUAL WE'LL WRAP UP THE
OPEN SESSION BY HEARING ANY
UPDATES FROM NEWG MEMBERS ON
WHAT EVERYONE HAS BEEN UP TO IN
THE NEUROETHICS SPACE.
BEFORE WE GET STARTED A FEW
HOUSEKEEPING ITEMS.
THIS OPEN SESSION IS LIVE TO TO
ARCHIVE LATER ON THE WEBSITES.
PLEASE MUTE YOUR LINE AND TURN
OFF YOUR VIDEO WHEN NOT
SPEAKING.
DURING DISCUSSIONS, FOR NEWG
MEMBERS, PLEASE TURN ON YOUR
VIDEO AND USE THE RAISE-HAND
OPTION IF YOU HAVE QUESTIONS OR
COMMENTS, YOU'LL BE CALLED ON
UPON TO UNMUTE IN TURN.
OPT FOR THE RAISE-HAND FUTURE SO
VIDEOCAST ATTENDEES CAN HEAR AND
SEE THE QUESTIONS.
WE KNOW EVERYONE IS BUSY.
WE REALLY APPRECIATE YOUR TIME
AND VALUE YOUR INPUT TODAY.
FINALLY, NONE OF THIS CAN HAPPEN
WITHOUT THE FABULOUS TEAM HERE
INCLUDING STAFF FROM ACROSS THE
BRAIN INSTITUTES AS WELL AS
COLLEAGUES HELPING WITH THE
BROADCAST.
I ESPECIALLY WANT TO THANK DR.
NINA HSU, COMMITTEE SPECIALIST,
WITH DR. SASKIA HENDRIKS,
CONSULTANT, AND DR. JOHN NGAI,
BRAIN DIRECTOR, FOR HIS SUPPORT
OF NEUROETHICS BROADLY.
I'M GOING TO TURN IT OVER TO ONE
OF THE CO-CHAIRS, DR. GRADY.
IT IS ALL YOURS.
>>THANK YOU, AND WELCOME.
I EXTEND MY THANK YOU AND
WELCOME TO THE MEMBERS OF THE
NEWG AND OUR INVITED SPEAKERS AS
WELL.
THANK YOU FOR BEING HERE TODAY.
I KNOW EVERYBODY'S BUSY.
WE HAVE A FULL AGENDA, AN
EXCITING AGENDA.
I THINK I'M REALLY LOOKING
FORWARD TO OUR DISCUSSIONS AND
DELIBERATIONS TODAY.
BUT FIRST I JUST WANT TO TAKE A
MINUTE TO RECOGNIZE THAT THIS IS
THE FIRST MEETING OF THE
NEUROETHICS WORKING GROUP WITH
NINA FARAHANY AS OUR CO-CHAIR,
AND I WANT TO RECOGNIZE PUBLICLY
IT IS WONDERFUL TO HAVE HER AS A
CO-CHAIR.
WE'RE ALL VERY FORTUNATE.
AS MANY OF YOU KNOW NINA IS THE
ROBINSON O. EVERETT
DISTINGUISHED PROFESSOR OF LAW
AND PHILOSOPHY AT DUKE
UNIVERSITY LAW SCHOOL, IMMEDIATE
PAST PRESIDENT OF NEUROETHICS
SOCIETY AND WEARS OTHER HATS IN
ADDITION TO HER WORK WITH US
WITH THE NEUROETHICS WORKING
GROUP.
TODAY SHE'S GOING TO LEAD OUR
FIRST DISCUSSION ON THE VARIOUS
HEALTH-RELATED WAYS THE BRAIN
CAN BE AFFECTED.
BUT BEFORE WE DO THAT, I'M GOING
TO TURN IT OVER TO JOHN NGAI,
THE BRAIN DIRECTOR, TO GIVE US
HIS UPDATE ON BRAIN INITIATIVE.
THANK YOU, JOHN.
>>THANKS VERY MUCH, CHRISTINE.
WELCOME TO ALL.
DELIGHTED TO HAVE YOU ALL HERE.
ALSO WELCOMING OUR NEWG
CO-CHAIR, DR. NINA FARAHANY.
THE LUNAR NEW YEAR IS OFF TO A
ROCKY START BUT I WISH YOU ALL A
HAPPIER AND PROSPEROUS YEAR OF
THE RABBIT.
SO LET'S SEE IF I CAN DO THIS
CORRECTLY.
I JUST HAVE A FEW BRIEF COMMENTS
AS CRITICAL CONDITION --
CHRISTINE SAID, WE HAVE A PACKED
AGENDA.
ARE WE SEEING THE CORRECT
SCREEN, FOLKS?
YES, NO?
>>YES, LOOKS GOOD.
>>PERFECT.
>>A QUICK UPDATE, OF WHAT'S
HAPPENING IN AND AROUND
NEUROETHICS AND BRAIN, I WANT TO
CALL YOUR ATTENTION TO THIS CALL
FOR SUPPLEMENT APPLICATIONS, NOT
FROM THE BRAIN INITIATIVE PER
SE, BUT FROM THE NIH'S OFFICE OF
SCIENCE POLICY OUT OF THE OFFICE
OF DIRECTOR, WHICH IS SEEKENING
APPLICATIONS FOR SUPPLEMENTS TO
CURRENTLY FUNDED AWARDS,
INCLUDING BRAIN INITIATIVE
FUNDED AWARDS, WHERE THE AIM IS
ENHANCE IMPACT OF CURRENTLY
FUNDED PROJECTS INTEGRATING
BIOETHICS PERSPECTIVES AND
APPROACHES INTO THEM.
HERE AT BRAIN WE FUND ALL KINDS
OF DIFFERENT PROJECTS THAT COULD
BE HIGHLY RELEVANT FOR SUCH A
SUPPLEMENT.
WE'VE TALKED HERE AND ELSEWHERE
ABOUT THE ETHICAL IMPLICATIONS
OF ACCESS AND USE OF EMERGING
AND LEADING EDGE
NEUROTECHNOLOGIES, HOW THEY
RELATE TO IMPORTANT ISSUES OF
INFORMED CONSENT.
ONE EXAMPLE, WE'VE TALKED ABOUT
THE BARRIERS TO ACCESS THAT
INVOLVE VARIOUS FACTORS
INCLUDING CULTURAL DIFFERENCES
AND SOCIOECONOMIC FACTORS.
WE ALSO HAVE TALKED ABOUT
RESEARCH ON LONG-TERM
OBLIGATIONS, OR POST OR
CONTINUING OBLIGATIONS AND I'LL
TOUCH ON THAT IN A MOMENT IN A
DIFFERENT CONTEXT, AND VERY
IMPORTANT CROSSING SUBJECTS, THE
ISSUE OF WHAT IT MEANS TO START
COLLECTING OR TO BE COLLECTING
HUMAN NEURAL DATA AND WHAT CAN
WE DO TO ASSURE SAFETY AND
PRIVACY AND GUARD AGAINST
UNINTENDED USES.
SO THESE ARE ROLLING SUBMISSION
APPLICATIONS, REVIEW WILL TAKE
PLACE SOON SO THESE ARE DUE
FEBRUARY 17.
YOU DON'T HAVE A WHOLE LOT OF
TIME BUT IF YOU'RE INTERESTED I
WOULD DEFINITELY LOOK INTO THIS.
THE IDEA IS SUPPORT RESEARCH
ABOUT BOTH ETHICAL ISSUES TO
DEVELOP OR SUPPORT AND EVIDENCE
BASE TO INFORM FUTURE POLICY
DECISIONS OR BE USED TO DEVELOP
OTHER AUGMENT BIOETHICS RESEARCH
CAPACITY.
HERE AT BRAIN WE DO SUPPORT
SCHOLARLY WORK IN THE
NEUROETHICS FIELD.
CHALLENGES IN MANY AREAS OF WHAT
WE DO, THIS IS REALLY A GREAT
OPPORTUNITY FOR SOME OF OUR
BRAIN INVESTIGATORS.
WE'RE INTERESTED AT NIH IN
MAKING AN INVESTMENT IN
INTEGRATING BIOET ETHICS
RESEARCH TO FACILITATE PUBLIC
ENGAGEMENT AND PARTICIPATION
BUILDING THERE'S WITH THE
RESEARCH ENTERPRISE.
TAKE A LOOK AT THAT IF YOU'RE
INTERESTED.
FOR YOU FOLKS WITH CURRENTLY
FUNDED BRAIN GRANTS THIS IS A
GREAT OPPORTUNITY TO SUPPLEMENT
YOUR WORK.
IT HAS TO BE WITHIN THE SCOPE OF
THE GENERAL SCOPE OF THE CURRENT
AWARDS AS WITH ANY SUPPLEMENT
TYPE OF PROJECT, BUT REALLY
COULD BE A GREAT OPPORTUNITY TO
EXPAND YOUR PROJECT IN AN
INTERESTING AND VERY IMPORTANT
WAY.
I MENTIONED CONTINUING TRIAL
RESPONSIBILITIES, THIS IS AN
ISSUE AROUND WHAT HAPPENS AFTER
A TRIAL IS OVER OR SOMETHING
HAPPENS WHERE THE MANUFACTURERS
OR FOLKS THAT ARE PARTICIPATING
IN THE STUDIES AS RESEARCHERS
ARE NO LONGER AVAILABLE.
AND PARTICULARLY ACUTE CASE OF
POST TRIAL RESPONSIBILITIES
INVOLVES SO CALLED INTRACRANIAL
APPROACHES WHERE WE'RE ACTUALLY
PLACING ELECTRODES AND SUCH IN
PEOPLE'S BRAINS.
WE HELD A WORKSHOP, OH GOSH,
ALREADY BACK IN MAY OF 2022, AND
WE BROUGHT IN WHAT WE FELT WERE
ALL THE STAKE HOLDERS WHO NEEDED
TO BE INVOLVED IN THIS
DISCUSSION ABOUT HOW TO CARE FOR
OUR PATIENTS, OUR HUMAN
PARTNERS, IN THESE ENDEAVORS.
AND WE INCLUDED DEVICE
MANUFACTURERS, INVESTIGATORS,
THE RESEARCHERS THEMSELVES AND
THE SURGEONS, ALSO FOLKS FROM
THE REGULATORY SIDE, PATIENT
ADVOCATES.
I MEAN, THE PATIENTS AND
ADVOCATES, THE MOST IMPORTANT
VOICE IN THE ROOM ARGUABLY COMES
FROM THE FOLKS BEING TESTED WITH
THESE NEW DEVICES AND
TREATMENTS.
AND THEIR CAREGIVERS AND
FAMILIES.
INSURANCE PROVIDERS, WE HAD
FOLKS FROM DIFFERENT FEDERAL
AGENCIES, REALLY TO SEE HOW BEST
TO COVER THE RESPONSIBILITIES
THAT WE HAVE FOR THESE PATIENTS
AND RESEARCH PARTICIPANTS, AND
THERE WAS A CONSENSUS THAT THERE
WAS A NEED, LESS OF A CONSENSUS
ABOUT WHO ACTUALLY WOULD BE
RESPONSIBLE FOR THESE DIFFERENT
POST-TRIAL OR CONTINUING TRIAL
NEEDS, BUT I THINK WE MADE GRADE
HEADWAY IN IDENTIFYING THE
ISSUES.
WE I THINK CAME TO -- AT LEAST I
CAME TO THE CONCLUSION THAT WE
NEEDED TO MOVE THE NEEDLE
SOMEWHAT, IF NOT TO PERFECTION
AT LEAST TOWARD PERFECTION.
RIGHT NOW THE CONVERSATIONS ARE
ONGOING.
WE HAVE FORMED -- WE MEANING THE
OFFICE OF SCIENCE POLICY, OFFICE
OF EXTRAMURAL RESEARCH AT NIH,
HAS ACTUALLY FORMED A WORKING
GROUP TO REALLY EXAMINE WHAT WE
CAN AND CANNOT DO TO MAKE THIS A
BETTER SITUATION SO THAT WE CAN
ASSURE THAT THE FOLKS WHO
PARTICIPATE IN THESE TRIALS ARE
PROPERLY CARED FOR TO THE BEST
OF OUR ABILITIES.
STAY TUNED.
WE'RE WORKING ON THIS LONG
PROCESS.
IT'S A COMPLEX SET OF ISSUES
THAT NOT ONLY INVOLVE INVASIVE
BRAIN IMPLANTS BUT ALSO REALLY
IN PRINCIPAL ALSO AFFECTS MANY
OTHER KINDS OF CLINICAL TRIALS.
STAY TUNED.
WE'RE HARD AT WORK ON THIS AND
APPRECIATE INPUT FROM ALL THE
STAKEHOLDERS WE'VE RECEIVED SO
FAR.
I THOUGHT I WOULD TOUCH VERY,
VERY BRIEFLY ON SOME COOL
SCIENCE THAT HAS ETHICAL
IMPLICATIONS IN THE BRAIN SPACE,
AS IT WERE.
I DON'T KNOW THAT WE'LL HAVE
MUCH TIME TO DIVE IN.
THE SECOND CASE I'LL TALK ABOUT
ACTUALLY IS VERY MUCH RELEVANT
TO THE DISCUSSION WE'LL HAVE IN
A MOMENT.
HERE IS JUST A PAPER FROM THE
DEVORE AND KUZUM LOOKING AT
ORGANOIDS IMPLANTED INTO ADULT
STAGE MICE.
THERE ARE A COUPLE COOL THINGS.
ONE IS THAT THEY DID IT AND USED
VARIOUS MEASURES TO SHOW THAT
THESE HUMAN-DERIVED BRAIN
ORGANOIDS COULD ACTUALLY
INCORPORATE INTO A MOUSE BRAIN
AND BECOME PART OF THE LOCAL
NETWORK, AND THE OTHER COOL
THING WAS TECHNOLOGY I BELIEVED
DEVELOPED BY THE DEVORE LAB
WHERE THEY DEVELOPED THIS
OPTICALLY CLEAR ELECTRODE THEY
COULD PLACE OVER THE IMPLANT
INCLUDING PART OF THE
SURROUNDING TISSUE, SO THEY
COULD ACTUALLY LOOK TO SEE HOW
WELL THIS ORGANOID IMPLANT COULD
INCORPORATE INTO THE RECIPIENT
BRAIN PHYSIOLOGICALLY,
ELECTRICALLY, AND COMPARE IT TO
THE SURROUNDING TISSUE.
SO, TECHNICAL INNOVATIONS FROM
THE BIOLOGY SIDE AS WELL AS
TECHNOLOGY --
ELECTROPHYSIOLOGICAL TECHNOLOGY
SIDE WITH GRAPHINE
MICROELECTRODES, SHOWING THE
ORGANOIDS INCORPORATE
FUNCTIONALLY INTO SURROUNDING
TISSUE, AND ACTUALLY
VASCULARIZED AND SHOW OTHER
FEATURES OF INTEGRATION BASED ON
BIOCHEMICAL MARKERS.
NOW, IT'S NOT PERFECT.
BUT IT'S ACTUALLY SHOWING --
THIS COULD BE A GREAT SYSTEM FOR
UNDERSTANDING HOW THESE
ORGANOIDS CAN FUNCTION AND MAYBE
ONE DAY BE USED FOR LOCAL
REPAIR.
NOW, THESE WERE IMPLANTED INTO
THE CORTEX, RESPONDING TO VISUAL
STIMULI PROBABLY FROM LOCAL
CONDUCTIVITY, NOT INPUT FROM
SENSOR STREAM THROUGH THE
THALAMUS, THESE WERE PLACED INTO
ADULT MICE WHERE IT'S SHOWN IN
SEPARATE STUDIES THAT LOCAL
NEUROGENESIS PROBABLY ALSO ONLY
INVOLVES LOCAL INTERACTIONS.
IT'S IMPORTANT TO NOTE A SIMILAR
STUDY FROM SERGIO'S LAB AT
STANFORD CAME OUT END OF LAST
YEAR WHICH LOOKED AT THE
INCORPORATION OF HUMAN ORGANOIDS
INTO NOW NEONATAL BRANDS, THEY
INCORPORATE INTO THE CIRCUIT, IN
THAT CASE THEY DO RECEIVE INPUT
FROM THE THALAMUS AS THIS PART
OF THE CORTEX NORMALLY WOULD,
BUT VERY IMPORTANTLY WHAT THEY
DID SHOW UNTIL THESE ORGANOIDS
WERE IMPLANTED INTO A HOST
RECIPIENT, IN THAT CASE A RAT,
THEY DID NOT SHOW FULL
MATURATION OF THE NEURONS OR
OTHER CELLS.
ORGANOIDS ARE A GREAT MODEL
SYSTEM FOR STUDYING HUMAN BRAIN
TISSUE AND HUMAN BRAIN CELL
TYPES, BUT WE STILL ARE NOT AT
THE STAGE WHERE THEY SERVE AS A
PERFECT MODEL.
THERE'S NO SUCH THING AS PERFECT
MODEL, BUT A PERFECT MODEL FOR
THE MATURE STATE.
WE HAVE A WAYS TO GO BUT CAN
HOPEFULLY LEARN GREAT LESSONS
FROM THE ORGANIZE TO BE A
POWERFUL SYSTEM FOR
UNDERSTANDING THE HUMAN BIOLOGY
OF THE BRAIN.
SO CLOSER TO OUR DISCUSSION
THAT'S COMING UP IS THIS PILOT
STUDY, LOOKING AT THE USE OF
ADAPTIVE OR RESPONSIVE DBS FOR
EATING CONTROL.
HERE IS A CASE STUDY SHOWING TWO
PATIENTS WHO HAD LOSS OF CONTROL
EATING THAT RESULTED IN BINGE
EATING DISORDER.
WHAT THEY DID HERE IS THEY
RECORDED FROM THE NUCLEUS
ACCUMBENS OF THE TWO PATIENTS
AND IDENTIFIED PHYSIOLOGIC
SIGNATURED THAT PRECEDED BINGE
EAT AND COULD SEE INCREASE IN
POWER OF LOW FREQUENC
OSCILLATION AND USE THAT AS
TRIGGER TO STIMULATE IN THE
NUCLEUS ACCUMBENS AND SHOW IN
THESE TWO PATIENTS INCREASE IN
SELF-CONTROL FOR BINGE EATING
BUT NOT NORMAL EATING, ALSO
WEIGHT LOSS WHERE THEY DIDN'T
ACTUALLY INSTRUCT THE PATIENTS
TO GO THROUGH OTHER STRATEGIES
FOR WEIGHT LOSS.
AGAIN, JUST A CASE STUDY WITH
TWO PATIENTS, THEY KNOW THE
CHALLENGES IN TRAINING THE
PATIENTS IN THE SETTING IN THE
LAB VERSUS REAL WORLD SETTING,
AND THIS IS AN ISSUE WITH THESE
ADAPTIVE DBS STUDIES, BUT ARE
REALLY MAYBE POINTING THE WAY TO
POWER OF USING THESE KINDS OF
NEUROMODULATORY APPROACHES,
PERSONALIZED NEUROMODULATORY
APPROACHES, TO AFFECT
INDIVIDUALS WITH SUCH DISORDERS.
NOW, THIS IS OPENS YOU WILL A
WHOLE HOST OF ETHICAL
CONSIDERATIONS ABOUT HOW WE
AFFECT THE BRAIN, WITH THESE
NEUROMODULATION TECHNIQUES,
WHETHER THEY BE INVASIVE IN THE
CASE HERE WITH USING DEEP BRAIN
STIMULATION, OR NON-INVASIVELY
AS WE'LL SEE USING OTHER
TECHNIQUES INCLUDING AS WE'LL
ALSO LEARN IN A BIT VIRTUAL
REALITY.
SO THIS WILL BE SURE A TOPIC OF
GREAT DISCUSSION IN THE NEXT
HOUR OR SO.
BEFORE WE GET THERE I JUST WANT
TO REMIND EVERYBODY TO SAVE THE
DATE FOR THE 9th ANNUAL BRAIN
INITIATIVE MEETING, WHICH IS
SCHEDULED FOR JUNE 12 AND 13.
YOU'LL SEE AN INITIAL
ANNOUNCEMENT I HOPE SOON ONCE WE
GET THE PAPERWORK STRAIGHTENED
OUT.
SO THIS IS NOT ETCHED IN STONE
BUT IF YOU USE A VERY DARK TYPE
1 PENCIL TO PUT IN YOUR
CALENDAR, PLEASE MARK THE DATE
OF JUNE 12 AND 13, MORE
INFORMATION FORTHCOMING, AND YOU
CAN LEARN MORE ABOUT THE BRAIN
INITIATIVE AT THIS WEBSITE OR
USE THIS SNAZZY NEW QR CODE.
I WILL STOP THERE.
I DON'T KNOW IF WE HAVE TIME FOR
QUESTIONS BUT OTHERWISE I'LL
TURN IT OVER TO THE CO-CHAIR,
PROFESSOR FARAHANY.
>>WE HAVE TWO MINUTES, JOHN, IF
THERE ARE QUESTIONS BEFORE WE
TRANSITION.
ALL RIGHT.
SEEING NONE, AT THIS MOMENT,
WHICH I'M SURE WILL COME LATER
WE'LL TRANSITION OVER.
I WANT TO INTRODUCE THE SESSION
AND MOTIVATION BEHIND THE
SESSION TODAY.
SO, WE WANTED TO FRAME THE
CONVERSATION TODAY AROUND
PERSUADING, ALTERING OR
MANIPULATING THE BRAIN.
WHAT IS THE LINE BETWEEN THEM
AND HOW WE MIGHT AS NEWG ENGAGE
WITH THESE ISSUES THAT WE'LL
DISCUSS AT 2:00 P.M.
EVERYTHING WE DO IMPACTS THE
BRAIN, WHETHER IT'S FROM THIS
CONVERSATION THAT WE'RE HAVING
TOGETHER TO DIFFERENT
INTERVENTIONS THAT MIGHT BE
UNDERTAKEN.
WHETHER IT IS IN THE MORE
FOCUSED NEUROSIDE FROM NEURO
FEEDBACK TO DIRECT STIMULATION,
WE WANTED TO FRAME THE
CONVERSATION TODAY MORE AROUND
THE EFFECTS ON THE BRAIN, RATHER
THAN NECESSARILY THE MODE OF
INTERVENTION.
AND WE WANTED TO INCLUDE WITHIN
OUR CONVERSATION AND
BRAINSTORMING WHERE AND HOW NEWG
MIGHT ENGAGE IN THIS SPACE, THE
BROADER CONSUMER-BASED DEVICES
AND INTERVENTIONS THAT ARE
LIKELY TO HAVE WIDER-SCALE
ADOPTION AND IMPACT TO MORE
TARGETED AND SELECTED
INTERVENTIONS.
IN SOME WAYS THE PRESENTATIONS
THAT WILL FOLLOW ARE REALLY JUST
A STARTING POINT FOR THINKING
ABOUT THE SPECTRUM OF
INTERVENTIONS THAT WE MIGHT
THINK ABOUT, FROM A
HEALTH-RELATED PERSPECTIVE FOR
THE BRAIN, WHETHER THAT'S
IMMERSIVE VIRTUAL REALITY IN A
HEALTH-RELATED CONTEXT TO DIRECT
STIMULATION OR INTERVENTION WITH
THE BRAIN FOR TREATMENT.
I'LL SAY I JUST GOT BACK FROM A
TRIP LAST WEEK IN SWITZERLAND
WHERE THE CONFERENCE AT THE
WORLD ECONOMIC FORUM WAS VERY
DEEPLY ENGAGED, THERE WERE MANY
SESSIONS ON THE METAVERSE,
VIRTUAL REALITY, SO I THINK
THINKING ABOUT THIS IN A BROAD
CONTEXT, THINKING ABOUT THE
IMPLICATIONS AND APPLICATIONS IN
A BROAD CONTEXT PARTICULARLY
WHERE A LOT OF GLOBAL LEADERS
SEE THE FUTURE COMING IS ONE OF
THE TOUCH POINTS FOR OUR
CONVERSATION.
I'VE DONE A DEEP DIVE RECENTLY
FOR A BOOK I'VE WRITTEN THAT
LOOKS AT THE ISSUES ON
MANIPULATION OF THE BRAIN,
PERSUASION OF THE BRAIN.
I'VE LOOKED AT ISSUES RANGING
FROM DISINFORMATION AND
MISINFORMATION TO APPEALING TO
HUERISTICS OR SHORTCUTS IN THE
BRAIN TO NEUROMARKETING
TECHNIQUES FOR THE BRAIN OR
ATTEMPTING TO INCUBATE DREAMS.
WHAT WAS REALLY CLEAR TO ME IN
THE DEEP DIVE I DID IS THAT
THERE'S A SIGNIFICANT DIVERSITY
OF THOUGHT ON HOW TO THINK ABOUT
THESE ISSUES FROM A
PHILOSOPHICAL PERSPECTIVE, FROM
A LEGAL PERSPECTIVE, OR FROM A
REGULATORY PERSPECTIVE.
SOME OF THE CONCERNS THAT
ACADEMICS AND OTHERS HAVE
FOCUSED ON AS WE THINK ABOUT
INTERVENTIONS IN THE BRAIN ARE
HIDDEN INFLUENCES IN THE BRAIN.
BUT THAT TURNS OUT TO BE A
PRETTY DIFFICULT IF NOT
UNTENABLE LINE AS A LOT OF THE
MORE RECENT SCHOLARSHIPS SUGGEST
THAT A LOT OF THE WAYS THAT ARE
ATTEMPTING TO PERSUADE OR CHANGE
THE BRAIN AREN'T HIDDEN BUT
QUITE AAPPARENT, NEVERTHELESS
MAY COMPROMISE AUTONOMY,
DIGNITY, OR WELL-BEING OF THE
INDIVIDUAL.
MORE RECENT SCHOLARSHIP
PARTICULARLY FROM BEHAVIORAL
ECONOMICS, FOR EXAMPLE,
RECOGNIZES THAT MANY INFLUENCES
ON THE BRAIN ARE NOT HITTEN, ONE
OF THE CONCERNS SHOULD BE
INTENTION TO CAUSE HARM,
IMPACTING THE BRAIN IN NEGATIVE
WAYS.
AND QUESTIONS ABOUT AUTONOMY AND
CONSENT ARE PARAMOUNT IN MANY
CONVERSATIONS.
TODAY WE WANT TO FOCUS ON
HEALTH-RELATED MODULATION OF THE
BRAIN PRESUMABLY FOCUS
INTENTIONALLY BENEFICIAL IMPACTS
ON THE BRAIN SO THE QUESTION OF
HARM WOULD BE PUT TO THE SIDE.
BUT MAY NEVERTHELESS RAISE
COMPLEX ETHICAL ISSUES FOR WHICH
GUIDANCE OR DIRECTION FOR
RESEARCHERS, CORPORATIONS, AND
GOVERNING BODIES MAY BE A
SIGNIFICANT VALUE.
WE WANTED TO OFFER A SPECTRUM IN
THE CONVERSATION AND
PRESENTATIONS THAT WILL FOLLOW
OF DIFFERENT WAYS OF IMPACTING
THE BRAIN, FROM ENGAGING WITH IT
FOR EXAMPLE THROUGH DEEP
DISTRACTION, SO WE'VE LOT ABOUT
CORPORATIONS USING IMMERSION TO
ENGAGE THE BRAIN BUT WHAT ABOUT
BENEFICIAL USES OF DOING SAME
ACTIVATIONS IN THE BRAIN IN
SURGICAL CONTEXTS OR IN OTHER
CONTEXTS.
WE ALSO WANTED TO LOOK AT WHAT
WE SORT OF SAW AS OPPOSITE END
OF THE SPECTRUM, WHICH IS MORE
DIRECT INTERVENTIONS TO REWIRE
OR CHANGE THE FUNCTIONING OF THE
HUMAN BRAIN.
WHILE THIS IS STARTING PLACE AND
HOW WE WERE THINKING ABOUT A WAY
TO DESIGN THE SPECTRUM OF THE
CONVERSATION THAT WE MIGHT
ENGAGE WITH, WE ALSO RECOGNIZED
THIS MIGHT NOT BE THE WAY IN
WHICH NEWG WOULD WANT TO SEGMENT
THE WORLD AS WE THINK ABOUT
MODULATION OF THE BRAIN OR THE
RIGHT WAY TO THINK ABOUT IT.
THE QUESTION IS WHETHER OR NOT
SOMETHING LIKE IMPLANTED VERSUS
WEARABLE TECHNOLOGY MAKES A
DIFFERENCE, WHETHER OR NOT
DIRECT VERSUS INDIRECT
INTERVENTIONS ON THE BRAIN MAKE
A DIFFERENCE, IF THOSE ARE
USEFUL WAYS FOR US TO THINK
ABOUT IT. AS WE TURN AFTER THIS
CONVERSATION, WHAT I'D LIKE YOU
TO KEEP IN MIND AS YOU HEAR THE
PRESENTATIONS IS THINKING WHAT
IS THE UNIQUE AND TARGETED VALUE
ADD THAT NEWG COULD PROVIDE.
AS YOU HEARD, THIS IS MY FIRST
OPPORTUNITY TO SERVE AS
CO-CHAIR.
I'M DELIGHTED TO HAVE THE
OPPORTUNITY TO DO SO.
ONE OF THE THINGS I HOPE TO
BRING IN MY ROLE AS CO-CHAIR IS
A FOCUS AT THE BEGINNING OF EACH
OF THESE CONVERSATIONS, REALLY
DECIDING WHAT IS IT WE HOPE IS
THE OUTPUT OR THE PRODUCT OF THE
ENGAGEMENT.
IT COULD BE A WORKSHOP THAT WE
HOPE TO THEN HAVE PROCEEDINGS
THAT FOLLOW FROM.
IT COULD BE THAT WE HOPE WE
WOULD HAVE TARGETED GUIDANCE
THAT WE WOULD PROVIDE TO
RESEARCHERS TO CORPORATIONS TO
OTHER GOVERNING BODIES.
IT COULD BE THAT WE HOPE THERE'S
A WHITE PAPER OR ACADEMIC
COLLABORATION THAT COULD BE BORN
OUT OF IT.
BUT AS YOU HEAR THE
PRESENTATIONS THAT FOLLOW, I'D
LOVE FOR YOU TO REALLY FOCUS ON
THAT QUESTION, WHICH IS, WHAT IS
THE RIGHT WAY FOR NEWG TO ENGAGE
WITH THESE QUESTIONS AND WHAT IS
THE INTENDED OUTPUT OR PRODUCT
THAT WE LOPE TO HAVE AS A RESULT
OF THESE CONVERSATIONS, AND IS
THERE UTILITY TO OUR ENGAGING
WITH THESE QUESTIONS UNIQUE OR
DISTINCT FROM ACADEMIC OR OTHER
ENGAGEMENT THAT HAS ALREADY
OCCURRED ON THESE ISSUES.
SO, WITH NO FURTHER ADO, I WILL
HAND IT OVER TO CHRISTINE TO
INTRODUCE OUR SPEAKERS FOR THE
FOLLOWING CONVERSATION, AND,
AGAIN, I'M DELIGHTED TO SERVE IN
THIS ROLE.
IT'S AN HONOR TO SERVE ALONGSIDE
CHRISTINE AND AN HONOR TO BE
GIVEN THE OPPORTUNITY TO SERVE
IN THIS CAPACITY AND I LOOK
FORWARD TO SERVING AS CO-CHAIR
OF NEWG.
>>THANK YOU, SHE'S GIVEN US A
LOT TO THINK ABOUT.
WE'RE PLEASED TO HAVE TWO
SPEAKERS TO GET US STARTED ON
THIS DISCUSSION TODAY.
I'LL INTRODUCE EACH ONE
SEPARATELY AND LET THE FIRST
SPEAK AND THEN GO TO THE SECOND
SPEAKER.
FIRST SPEAKER IS DR. ANDREW
CRYSTAL FROM UNIVERSITY OF
CALIFORNIA IN SAN FRANCISCO.
DR. KRYSTAL IS THE RAY AND
DAGMAR DOLBY DISTINGUISHED
PROFESSOR IN PSYCHOLOGY AND
NEUROLOGY AT UNIVERSITY OF
CALIFORNIA, SAN FRANCISCO,
DIRECTOR OF UCSF LABORATORIES
AND VICE CLAIRE -- VICE CHAIR N
RESEARCH FOR PSYCHIATRY.
I WONDER WHEN HE SLEEPS.
HE FOCUSES ON DEVELOPMENT OF
BIOMARKERS FOR MOOD AND SLEEP
DISORDERS AND THEIR APPLICATION
IN DEVELOPMENT OF NOVEL AND
PERSONALIZED TREATMENTS FOR
THESE CONDITIONS.
TODAY HE'S GOING TO SPEAK TO US
ABOUT CLOSED-LOOP
NEUROMODULATION IN AN INDIVIDUAL
WITH TREATMENT-RESISTANT
DEPRESSION.
WELCOME, DR. KRYSTAL.
THANK YOU FOR JOINING US.
>>THANK YOU VERY MUCH.
IT'S WONDERFUL TO HAVE THE
OPPORTUNITY TO BE ABLE TO TALK
WITH YOU TODAY.
I REALLY APPRECIATE IT.
LET ME FIRST GET MY SLIDES UP.
I'M PRESENTING THIS WORK ON
BEHALF OF A SUBSTANTIAL TEAM OF
WHICH I'VE NOT BEEN ABLE TO LIST
ALL THE MEMBERS ON THIS SLIDE
WHO HAVE BEEN JUST SPECTACULAR
TO WORK WITH AND A GREAT
OPPORTUNITY FOR ME.
I WANT TO START BY RAISING THE
QUESTION ABOUT HOW CHALLENGING
IT IS TO DEVELOP A DEEP BRAIN
STIMULATION TREATMENT FOR
DEPRESSION.
WHEN WE WORK WITH THE CONDITION
WHERE IT'S NOT RESOLVED WHERE
THE PATHOLOGY IS LOCATED IN THE
BRAIN, IT LEAVES OPEN THE
QUESTION OF WHERE SHOULD YOU
STIMULATE, I THINK THAT IS NOT
CLEAR BASED ON THE EXPERIENCE
WE'VE HAD TO DATE.
THERE ARE MANY, MANY STUDIES
CARRIED OUT THAT ALL POINT TO
DIFFERENT REGIONS OF THE BRAIN.
SO IT SUGGESTS POSSIBILITY THAT
THERE IS HETEROGENEITY AMONG
PEOPLE.
AND THAT'S BUILT INTO THE
DIAGNOSTIC STRUCTURE OF THIS
CONDITION.
THE DSM DIAGNOSIS REQUIRES THAT
A PERSON HAVE FIVE OUT OF NINE
POSSIBLE SYMPTOMS, AND SO YOU
COULD HAVE TWO PEOPLE WHO HAVE
DEPRESSION AND HAVE ONLY ONE
SYMPTOM IN COMMON.
AND WE SEE HUGE VARIATIONS.
SOME PEOPLE SLEEP TOO LITTLE,
TOO MUCH, EAT TOO LITTLE, EAT
MORE THAN USUAL.
IT'S QUITE VARIED.
WE DON'T KNOW IF THESE ARE TRUE
PATHOLOGICAL PHENOTYPES BUT IT'S
VERY CLEAR THERE'S -- THERE'S A
LOT OF VARIETY IN THE PATIENTS
AND RESULTS OF STUDIES WHICH
SUGGEST THAT THIS IS LIKELY TO
BE THE CASE.
ANOTHER POINT IS THAT SO FAR
THERE HAVE BEEN A NUMBER OF
EFFORTS THAT HAVE TRIED TO DO
DIRECT BRAIN STIMULATION AND
THESE HAVE ALL INVOLVED
CONTINUOUS STIMULATION WHERE
ELECTRICAL STIMULUS IS TURNED
ON, LEFT ON DAY AND NIGHT FOR
DAYS TO YEARS.
AND TO ME SOME IMPORTANT
QUESTIONS EMERGE FROM WORKING
WITH PATIENTS WITH DEPRESSION
FOR ALMOST 40 YEARS, PEOPLE HAVE
SYMPTOMS THAT VARY QUITE A BIT,
EVEN THOSE WITH VERY SEVERE
TREATMENT RESISTANT DEPRESSION,
AND IT'S NOT CLEAR WHAT IT'S
DOING WHEN YOU STIMULATE WHEN
PEOPLE DON'T HAVE SYMPTOMS.
WHAT'S IT DOING WHEN PEOPLE ARE
ASLEEP?
THESE QUESTIONS HAVE NOT REALLY
BEEN DRILLED DOWN ON VERY DEEPLY
AND WE DON'T HAVE GREAT
UNDERSTANDING OF IT.
TO ME, IT RAISES POSSIBILITY YOU
COULD HAVE PRODUCTIVE NEURAL
ADAPTATION THAT LIMIT HOW
EFFECTIVE TREATMENTS CAN BE.
THERE'S ANOTHER CHALLENGE, HOW
DO YOU DOSE THE TREATMENTS?
THE HISTORY OF DEPRESSION HAS
PRIMARILY DOMINATED BY
TREATMENTS THAT TAKE FOUR TO
EIGHT WEEKS TO WORK, FOR EXAMPLE
SEROTONIN REUPTAKE AND OTHERS.
YOU HAVE TO WAIT.
THAT LEAVES THE QUESTION HOW
SHOULD I DOSE THIS INDIVIDUAL
WHO I'M WORKING WITH TODAY WHEN
I WON'T KNOW IF THAT IS GOING TO
MANIFEST AND BENEFIT FOR QUITE A
WHILE?
AND THE ASSUMPTION SOME CHANGE
HAPPENS IN THE BRAIN OVER TIME,
SYNAPTONEOGENESIS, NEUROGENESIS,
DEEP BRAIN STIMULATION TRIGGERS
THAT MEDIATES THE
ANTI-DEPRESSANT EFFECT THAT'S
DISTINCT FROM WHAT HELPS WHEN
YOU ORIGINALLY STIMULATE, AND
WHETHER THERE'S ANY INDICATOR OF
THAT IN THE INITIAL STIMULUS
RESPONSE AND WHETHER OR NOT IT'S
NECESSARY FOR THIS 4 TO 8 WEEK
PERIOD TO HAPPEN TO GET A ROBUST
ANTI-DEPRESSANT EFFECT IS
LARGELY BASED ON THEORY AND
HISTORY BUT WE KNOW FROM RECENT
EXPERIENCE WITH DRUGS LIKE
KETAMINE AND SOME OTHER
EXPERIENCES ONE OF WHICH I'LL
TALK ABOUT IN A LITTLE BIT THAT
YOU CAN SEE IMMEDIATE BENEFIT.
SO IF YOU CAN SEE IMMEDIATE
BENEFIT, IT CALLS INTO QUESTION
THAT THIS IS REALLY NECESSARY OR
ACTUALLY REALLY FUNDAMENTAL TO
THE WAY ANTIDEPRESSANTS WORK.
GIVEN THESE CHALLENGES, IT'S NOT
SURPRISING SOME OF THE PIVOTAL
STUDIES CARRIED OUT TO DATE WITH
DEEP BRAIN STIMULATION FOR
DEPRESSION HAVE NOT SHOWN
THERAPEUTIC EFFECTS, THIS IS ONE
STUDY WITH VENTRAL CAPSULE
STIMULATION, NO EFFECT VERSUS
SHAM.
AND ANOTHER WHERE TREATMENT WAS
STOPPED IN THE MIDWAY ANALYSIS
DUE TO LACK OF CLEAR EVIDENCE
THAT THERE'S LIKELY TO BE
BENEFIT, SUBCOLOSSAL
STIMULATION, IN BOTH STUDIES I
PARTICIPATED AND IT WAS
COMPLICATED BECAUSE WE WERE TOLD
TO TITHE RATE BASED ON IMMEDIATE
EFFECT BUT WE SHOULD USE THAT AS
WAY TO DOSE, CONFUSING BECAUSE
IT'S NOT SO CLEAR THOSE ARE
INTIMATELY RELATED TO EACH
OTHER..
ONE THAT IS PROMISING IS TO
ACTUALLY DO EXPLORATORY STIMULUS
RESPONSE MAPPING TO TRY TO
DETERMINE THE BEST LOCATION AND
STIMULUS PARADIGM SETTINGS.
FOR EXAMPLE, AMPLITUDE PULSE
WITH FREQUENCY AND SO ON.
THAT FOR EACH PERSON.
AND THIS IS CONSISTENT WITH
MODEL OF HETEROGENEITY, WE MIGHT
NEED TO STIMULATE DIFFERENT
PEOPLE IN DIFFERENT WAYS, BUT IT
RAISES AN IMPORTANT QUESTION
WITH RESPECT TO PREVAILING MODEL
THAT YOU CAN'T DO THIS IF YOU
CAN'T PREDICT THE THERAPEUTIC
EFFECT RIGHT AWAY.
YOU HAVE TO -- IDEALLY YOU WOULD
SEE A THERAPEUTIC EFFECT RIGHT
AWAY AND COULD TRY OUT A BUNCH
OF LOCATIONS AND PARADIGMS AND
SO ON BUT IMAGINE IF YOU WERE
TRYING TO DO THIS IN THE CURRENT
MODEL YOU'D HAVE TO TRY
SOMETHING, WAIT 4 TO 8 WEEKS,
TRY SOMETHING AGAIN AND SEE DOES
IT WORK.
IT'S JUST UNTENABLE.
IT'S HUGELY LIMITING AND IF
THAT'S WHAT'S NEEDED, THAT'S
WHAT NEEDED AND PROGRESS WILL BE
SLOW.
BUT IF THERE'S AN ALTERNATIVE
YOU CAN DO SOMETHING LIKE THIS
IT WOULD BE A GAME CHANGER FOR
BEING ABLE TO OPTIMIZE AND
PERSONALIZE.
SO, ANOTHER ELEMENT IS BASED ON
THE IDEA THAT THE SYMPTOMS
AREN'T PRESENT ALL THE TIME AND
WHAT ARE WE DOING WHEN SYMPTOMS
ARE ABSENT AND DURING SLEEP AND
SO ON.
AND THE STRATEGY IS TO USE
CLOSED LOOP.
CLOSED LOOP IS BASED ON ONLY
STIMULATING WHEN NEEDED BASED ON
BIOMARKER OF THE STATE YOU'RE
HOPING TO TREAT SO YOU
CONTINUOUSLY SENSE BRAIN -- IN
THIS CASE BRAIN ELECTRICAL
ACTIVITY RECORDED WITH
INTRACRANIAL EEG AS BIOMARKER,
SENSE THE SIGNALS CONTINUOUSLY,
AND YOU HAVE A MODEL FOR WHAT
CONSTITUTES THE BRAIN ELECTRICAL
ACTIVITY DURING THE STATE OF
INTEREST, IN OUR CASE SEVERE
DEPRESSION, AND YOU DO SOME
COMPUTATION CONTINUOUSLY TO
ASSESS DOES THE BRAIN ELECTRICAL
ACTIVITY CONFORM TO THE PATTERN
THAT IS PREDICTIVE OF BEING IN A
MORE SEVERE DEPRESSED STATE AND
THEN ONLY TRIGGER STIMULATION
WHEN THAT BRAIN ELECTRICAL
ACTIVITY PATTERN IS PRESENT.
SO USE THE BIOMARKER TO DRIVE
TREATMENT, CLOSED LOOP COULD BE
DONE WITH THINGS OTHER THAN
BIOMARKER, COULD BE DONE WITH
BEHAVIOR, WIDE VARIETY OF
THINGS, BUT YOU'RE USING SOME
METRIC OF THE STATE YOU'RE
TRYING TO TREAT TO FEED IT BACK
JUST LIKE YOU USE THE THERMOSTAT
IN YOUR HOME, A DEVICE SIMILAR
TO CLOSED LOOP FOR TREATMENT OF
DEPRESSION TRIGGERS THE HEAT OR
AIR CONDITIONING TO COME ON ONLY
WHEN A MEASURE OF THE
ENVIRONMENTAL TEMPERATURE SAYS
THAT IT'S NEEDED.
AND KICKS IN AND TURNS OFF SO
YOU GET VERY LIMITED TIME PERIOD
OF EFFECT BUT ONLY WHEN IT'S
NEEDED.
THE OPEN-LOOP APPROACH WOULD BE
TURN ON HEAT AND LEAVE IT ON ALL
THE TIME, AND IF THE HOUSE GETS
TOO HOT YOU MANUALLY TURN IT
OFF.
BUT IN THEORY IT ONLY CAN MOVE
IN ONE DIRECTION.
SO, THIS REQUIRES AN IMMEDIACY
MODEL BECAUSE YOU'RE HOPING
YOU'LL GET BENEFIT WHEN YOU
STIMULATE AND YOU'RE GOING TO
STOP AND IF YOU CAN'T GET
BENEFIT FROM THAT IT HAS TO BE
THE CASE THAT YOU NEED
CONTINUOUS TREATMENT FOR A LONG
PERIOD OF TIME THIS SHOULDN'T
WORK IN THE 4 TO 8 WEEK MODEL.
IT MEANS THERE'S A STABLE
BIOMARKER, A BIOMARKER CAN BE
FOUND AND THAT IT'S STABLE.
WE TOOK THIS APPROACH TO JUMP TO
THE CHASE, AND WE DID IT WITH
THE STRONG BELIEF THAT WE COULD
ACHIEVE IMMEDIATE THERAPEUTIC
EFFECTS WITH DEEP BRAIN
STIMULATION ON THE WORK OF OUR
TEAM DIE EDDIE CHANG, LEAD
INVESTIGATOR FOR THE DARPA
SUBNETS STUDY IN EPILEPSY,
ABILITY TO MODULATE MOOD
SYMPTOMS RIGHT AWAY, LED TO SOME
SENSE THIS COULD BE POSSIBLE.
HYPOTHESIS THAT WE COULD DO
STIMULUS RESPONSE MAPPING AND
OPTIMIZATION AND PERSONALIZATION
FOR DEPRESSION WITH DEEP BRAIN
STIMULATION AND THAT WE COULD
THEN USE THAT CLOSED-LOOP MODEL
AND THAT THIS WOULD BE POSSIBLE
AND FEASIBLE.
WE CARRIED OUT A STUDY, PRESIDIO
TRIAL, MEANT TO BE
PROOF-OF-CONCEPT APPROACH TO
THESE FEATURES, TO SEE IF WE
COULDN'T DO DEEP BRAIN
STIMULATION IN A CLOSED-LOOP
MODEL THAT'S PERSONALIZED WITH A
MODEST NUMBER OF PEOPLE WHO HAD
SEVERE TREATMENT RESISTANT
DEPRESSION, TARGETING TREATING
APPROXIMATELY 13 PEOPLE, AND
THESE PEOPLE HAD TO BE VERY
RESISTANT, FAIL EVERYTHING
BASICALLY OUT THERE, USING THE
NEUROPACE RNS DEVICE TO DELIVER
CLOSED LOOP TREATMENT, FDA
APPROVED FOR TREATING EPILEPSY,
SO IT'S AVAILABLE.
STUDY COMPRISED OF THREE STAGES.
FIRST WHERE PEOPLE ARE ADMITTED
TO EPILEPSY MONITORING UNIT, AND
WITH IMPLANTATION OF 10 DEPTH
ELECTRODES, EACH WITH 16
CONTACTS, AND WE DO A STIMULUS
RESPONSE MAPPING AND CONTINUOUS
EEG, RECORDING, WITH GOAL OF
DEVELOPING PERSONALIZED
STIMULATION STRATEGY FOR EACH
PERSON AND BIOMARKER, AND THEY
GET EXPLANTED AFTER 10 DAYS AND
THEY GET IMPLANTED WITH
NEUROPACE SYSTEM, RNS SYSTEM,
PROGRAMMED TO IMPLEMENT
CLOSED-LOOP OVER THE CAPACITY
FOR THAT, AND TO IMPLEMENT
CLOSED LOOP WITH STIMULATING IN
THE PERSONALIZED APPROACH
IDENTIFIED IN STAGE 1 AND USING
THE BIOMARKER TO TRIGGER
TREATMENT IN STAGE 2.
BIOMARKER THAT WAS ALSO
IDENTIFIED IN STAGE 1.
STAGE 2 INVOLVES ADDITIONAL
PERIOD OF REESTABLISHING THE
BIOMARKER AND THERAPEUTICS
EFFECTS BECAUSE ELECTRODES ARE
NOW NEW AND WHILE WE HOPE THEY
ARE IN EXACTLY THE SAME SPOT WE
KNOW IT'S NOT HUMANLY POSSIBLE
EVEN THOUGH EDDIE SEEMS TO BE
SUPER HUMAN, HE'S NOT AND THERE
ARE SLIGHT DIFFERENCES IN
LOCATION.
THEN WE HAVE A THIRD PHASE WHERE
WE DO A RANDOMIZED DOUBLE BIND
CROSSOVER STUDY OF EFFICACY
VERSUS SHAM AND SAFETY.
THIS IS A PICTORIAL
REPRESENTATION OF STAGE 1 WHERE
WE DO THIS 10-DAY
STIMULUS-RESPONSE MAPPING AND
RECORDING PERIOD, IF WE'RE
SUCCESSFUL IN IDENTIFYING
THERAPEUTIC EFFECT IN SOME AREA
WITH SOME SET OF STIMULUS
PARAMETERS WE MOVE TO STAGE 2,
DO THE VERIFICATION AND THEN
OPTIMIZATION IMPLEMENTS CLOSED
LOOP AND ONCE WE HAVE
IMPLEMENTED THAT AND SHOWN 50%
REDUCTION WE MOVE TO CROSSOVER
STUDY IN THE FOLLOWING STAGE.
SHOWING HERE WE IMPLANTED 10
DEPTH ELECTRODES IN FIVE
LOCATIONS BILATERALLY.
THIS IS BASED ON EXHAUSTIVE
REVIEW OF THE PUBLISHED
LITERATURE AND EXPERIENCE IN THE
FIELD WITH DEEP BRAIN
STIMULATION OF THE SITES MOST
EFFECTIVE AND WHERE BIOMARKERS
HAVE BEEN IDENTIFIED AND SO ON.
JUST TRYING TO PULL TOGETHER A
COMPLEX LITERATURE TO LOOK AT
THE MOST PROMISES SITES.
JUMP TO THE CHASE, WE'VE
ACTUALLY GOTTEN THREE PATIENTS
THROUGH STAGE 1, ONE PATIENT ALL
THE WAY THROUGH, ONE FINISHED
STAGE 2.
WE PUBLISHED A CASE REPORT, TWO
CASE REPORTS ACTUALLY OF THE
FIRST PATIENT, AND WE HAD DONE
THROUGHOUT OUR INITIAL
ASSESSMENT IN THE EPILEPSY
MONITORING UNIT INITIAL PERIOD
AND THROUGH ALL THE STAGES WE
USE A SERIES OF MEASURES TO
ASSESS DEPRESSION, A WHOLE OTHER
DISCUSSION HOW BEST TO DO THIS
BECAUSE WE HAVE TO GET REPEATED
ASSESSMENTS, EITHER OUT
SELF-RATED SHORT VERSION OF
HAMILTON THAT PICKS UP THINGS
THAT CHANGE QUICKLY OVER TIME,
VISUAL SCALE RATING.
IN ALL THREE EFFECTS OF
STIMULATION IN SOME PLACES ARE
IMMEDIATE AND REPRODUCIBLE, THAT
IS STIMULATE THE SAME AREA
MULTIPLE TIMES YOU ALMOST ALWAYS
SEE THE SAME EFFECT.
IT'S AN EFFECT LIKE AN RDoC
LIKE DIMENSION, INCREASING
ACTIVITIES, PLEASURE, NOT
NECESSARILY ANTI-DEPRESSANT AND
FOR SOME PEOPLE THAT GOES WITH
ANXIETY OR DOESN'T FIX THE
PROBLEM.
IF THEY DON'T HAVE A PROBLEM
WITH LOSS OF PLEASURE, DOING
SOMETHING THAT INCREASES
PLEASURE IN INTEREST DOESN'T FIX
THEIR PROBLEM.
WE SAW THIS LITERALLY THERE WAS
VARIATION WHETHER PEOPLE FOUND
THOSE INCREASES IN CAPACITY AND
SPECIFIC DIMENSIONS THERAPEUTIC,
SOME HELPFUL IN SOME CASES, SOME
HELPFUL IN OTHER PLACES.
IF WE STIMULATE FIVE MINUTES TO
KEY EFFECTS UP TO 30 MINUTES,
SOMETIMES AN HOUR.
WE COULDN'T HAVE LUXURY OF
WAITING TO SEE HOW LONG THEY
LASTED, ALMOST ALL CASES,
BECAUSE THE 10-DAY PERIOD OF
EXPLORATION WAS JAM-PACKED.
THE LONGEST WE WOULD SEE WAS
WHEN WE WOULD DO INTERMITTENT
STIM TESTING TO IDENTIFY OPTIMAL
SETTINGS AND SOMETIMES SEE FOR
UP TO 3 HOURS OF EFFECT.
WE ALSO SAW STATE DEPENDENCE
WHICH SHOULD HAVE BEEN
ANTICIPATED BUT I THINK I HADN'T
THOUGHT OF THIS THAT SOMETIMES
YOU DON'T SEE EFFECTS BUT THAT'S
BECAUSE THE STATE OF THE PERSON,
STATE OF THEIR BRAIN, VARIES.
SOMETIMES WHEN PEOPLE ARE SLEEPY
THE CIRCUITS ARE IN DIFFERENT
STATES THAN ALERT, DIFFERENT
NUMBER OF DEPENDENCIES, THIS WAS
A CLEAR ONE FROM OUR INITIAL
EFFORTS TO DO THIS, TURNED OUT
TO BE USEFUL IN STRIKE TO
UNDERSTAND.
QUICKLY SHOWING FIGURES ON THE
LEFT, DOSE-RESPONSE, EVIDENCE WE
SAW BENEFIT IN IMPROVEMENT IN
ANTI-DEPRESSANT EFFECTS, WE ONLY
HAD A 20-MINUTE PERIOD HERE
BETWEEN FIRST STIM AND NEXT
STIM, SO WE COULDN'T SAY IT
LASTED MORE THAN 30 MINUTES FROM
ONSET OF THE STIMULATION,
BECAUSE WE HAD TO GO ON TO THE
NEXT THING WE DID BUT SAW THIS
REPEATEDLY.
THE OTHER, ON THE RIGHT SIDE IS
THREE FIGURES, FIGURES THAT
DEPICT STATE DEPENDENCE.
ON THE LEFT YOU SEE THE LEVEL OF
AROUSAL, WHETHER POSITIVE ALERT,
IF YOU'RE NEGATIVE IT MEANS
YOU'RE MORE SEDATED.
AND THE ARROW GOING UP
ANTI-DEPRESSANT, GOING DOWN SAYS
YOU GOT WORK IN YOUR
ANTI-DEPRESSANT EFFECT AND THIS
SAYS WE FOUND IN THE CORTEX THE
PATIENT SLEEPY THAT IT MAKES
THEM WORSE, IF THEY ARE MORE
ALERT THEN IT IMPROVES THEIR
DEPRESSION.
WHEREAS THE SAME SORT OF PATTERN
WAS SEEN IN THE CINGULATE, THE
STRIATUM WAS NOT DEPENDENT ON
THIS AND THIS KIND OF THING
SEEMS TO VARY FROM SITE TO SITE.
LIMITING TIME I JUST NEED TO
SUMMARIZE A FEW THINGS AND THEN
I'LL STOP.
WE MOVE THEN TO THE NEXT PHASE.
FIRST WE WERE ABLE TO FIND A
BIOMARKER, 77% ACCURATE, LED TO
BENEFIT, A FEW TIMES IT DIDN'T.
THE SITE FUNCTIONED AS AN
INTERCONNECTED CIRCUIT AND WE
VERIFIED THIS BY DOING EVOKED
POTENTIAL MAPPING STIMULATING
STRIATUM, YOU CAN SEE THE DOTS
HOW MUCH RESPONSE DID YOU GET IN
DIFFERENT PARTS OF THE BRAIN.
ONE OF THE RELATIVELY HIGHER
RESPONDING PARTS WAS THE
BASOLATERAL AMYGDALA, THE
ORANGISH -- NOT THE BRIGHT
ORANGE, THAT WAS IN HIPPOCAMPUS,
BUT AMYGDALA LOTS OF SITES ARE
INTERCONNECTED BUT THE BIOMARKER
WAS PRESENT IN AMYGDALA, THE
FIGURE ON THE RIGHT SHOWS THAT
WHEN YOU STIMULATE IT AND
THERE'S IMPROVEMENT THEN YOU
NORMALIZE THE BIOMARKER WHICH IS
CRITICAL FOR IMPLEMENTING CLOSED
LOOP, YOUR STIMULATION DOESN'T
NORMALIZE THEN YOU DON'T STOP
SIMULATING SO THESE WERE THE
INGREDIENTS THAT LED US TO DO
THAT CHOICE, WE WENT TO STAGE 2,
VERIFIED THERAPEUTIC EFFECTS AT
TWO CONFIGURATIONS, IN THE
VENTRAL CAPSULE, TITRATED BELOW
DETECTED BY THE PATIENT, WE
WANTED THIS EFFECT TO BE AS
SUBTLE AS POSSIBLE, TURNED OUT
IT WAS POSSIBLE FOR LEADING TO
THERAPEUTIC EFFECT, VERIFIED
BIOMARKER WITH AMYGDALA GAMMA
BEING ASSOCIATED WITH THE
DEPRESSION OUTCOME.
AND WE FOUND CHRONICALLY THAT
THIS WAS QUITE THERAPEUTIC FOR
THIS PATIENT.
INTERESTINGLY, JUST TO GIVE A
DIFFERENCE BETWEEN CLOSED LOOP
AND OPEN LOOP, THIS PERSON IS
BEING STIMULATED IN 6-SECOND
BURSTS, AND GETS AROUND 470 OF
THESE A DAY, WHICH IS A TOTAL OF
AROUND -- BETWEEN 15 AND 30
MINUTES OF STIMULATION A DAY
VERSUS OPEN LOOP WHICH WOULD BE
24 HOURS.
SO A LOT LESS INTENSIVE IN
INTERVENTION, ALSO CONSERVES
BATTERY LIFE, ET CETERA.
THIS PERSON SAW DRAMATIC
REDUCTION IN SYMPTOMS
IMMEDIATELY FIRST TIME WE
STIMULATED VENTRAL CAPSULE,
EVERY TIME AFTERWARDS, LOWERED
TO WHERE YOU CAN DETECT IT, AND
DID CLOSED LOOP SHE HAD
SIGNIFICANT AND SUSTAINED
REDUCTION AS YOU CAN SEE ON THE
RIGHT, HAMILTON DEPRESSION, AND
SCALES DROPPED AND STATE DOWN
DRAMATICALLY AND HAVE DONE SO
FOR A YEAR.
THERE'S DETAILS TO THAT, I DON'T
HAVE TIME TO GO INTO, BUT ALSO
THE IMPROVEMENT IN SYMPTOMS WAS
LINKED TO THE BIOMARKER AND
STIMULATIONS RECEIVED.
THIS IS SOMETHING THAT WAS VERY
EVIDENT TO THIS INDIVIDUAL WHO
FEELS LIKE HER LIFE HAS BEEN
CHANGED BY THIS AND HAS BEEN
HUGELY VALUABLE IN HER ABILITY
TO FUNCTION AND GET ON WITH HER
LIFE WHICH WAS STYMIED BY SEVERE
TREATMENT RESISTANT DEPRESSION.
I WANT TO MAKE THE LAST POINT
THAT WE'VE TREATED A SECOND
PERSON WHO MADE IT THROUGH STAGE
2 AND WE'VE SEEN THE STADIUM
KIND OF RESULTS.
MORE COMPLICATED IN TERMS OF
THIS IS A PERSON WITH WAY MORE
VARIATION IN SYMPTOMS, AND AT
ONE POINT WE THOUGHT THAT SHAM
WAS BEING AFFECTED BECAUSE WHEN
WE STARTED TO DELIVER
TREATMENTS, THERE WERE
PRESUMABLY ADAPTATIONS WHETHER
THIS IS SEVERITY LEVEL DROPPED
ON AVERAGE SIGNIFICANTLY BELOW
BUT AT 10 HERTZ WAS MORE
EFFECTIVE THAN A SHAM AND HE'S
NOW GOING INTO OUR THIRD PHASE
FOR THE CROSSOVER STUDY IN THE
NEAR FUTURE.
SO TO CONCLUDE, WE HAVE SEEN
SOME PROOF OF CONCEPT HERE THAT
YOU CAN DO PERSONALIZED
TARGETING USING
STIMULUS-RESPONSE MAPPING AND WE
SEE CONSISTENT EFFECTS ACROSS
PEOPLE IN DIMENSIONS OF BEHAVIOR
BUT DIFFERENT TYPES ARE
EFFECTIVE.
WE TREATED THREE THROUGH STAGE
1, ALL WERE DIFFERENT.
VENTRAL CAPSULE, VENTRAL
STRIATUM IN ONE.
WE WERE ABLE TO FIND BIOMARKERS
IN ALL THREE, SOME PEOPLE THEY
WERE STRONGER RELATIONSHIP WITH
SYMPTOMS BUT BIOMARKERS IN
DIFFERENT LOCATIONS AND
DIFFERENT BANDS AND SO ON.
WE'VE SEEN THIS IS SAFE AND CAN
BE EFFECTIVE IN TWO PEOPLE
ESTABLISHING PROOF OF CONCEPT
FOR THE APPROACH, I THINK, AND
WE'VE SEEN OVER AND OVER
IMMEDIATE THERAPEUTIC EFFECTS
WHICH CHALLENGES THE MODEL TO
STIMULATE CONTINUOUSLY OR WAIT 4
TO 8 WEEKS AND WE'RE IN THE
MIDDLE OF THIS STUDY WHICH I
FEEL PRIVILEGED TO BE ABLE TO
CARRY OUT.
I'LL STOP AND SEE IF WE HAVE
TIME FOR QUESTIONS.
>>THANK YOU, DR. KRYSTAL.
DOES ANYONE HAVE AN IMMEDIATE
FACTUAL QUESTION FOR DR.
KRYSTAL?
IF SO NOW WOULD BE THE TIME,
BEFORE WE INTRODUCE THE SECOND
SPEAKER, AND THEN WE'LL HAVE A
DISCUSSION OF OVERARCHING
ETHICAL QUESTIONS THAT WERE PUT
UP.
NITA.
GO AHEAD.
>>THANK YOU FOR THE WONDERFUL
PRESENTATION, RICH AND DEEPLY
INFORMATIVE.
SINCE THE STIMULATION SITE IS
DIFFERENT PER PATIENT AND
BIOMARKERS ARE DIFFERENT CAN YOU
UNPACK A LITTLE BIT BOTH HOW
YOUR TRAINING ON PARTICULAR
SITES OF INDIVIDUALS -- HOW
YOU'RE TRAINING ON PARTICULAR
SITES OF THE INDIVIDUALS TO
FIGURE THAT OUT AND SINCE
STIMULATION IS CLOSED LOOP
VERSUS OPEN LOOP OVER TIME HOW
DO YOU ENSURE THE SITE IS STABLE
OVER TIME ONCE THE STIMULATION
ACTUALLY OCCURS?
>>GREAT QUESTIONS.
IF I HAD THREE HOURS I COULD
START TO DO JUSTICE TO THE
ANSWERS.
THE SHORT ANSWERS ARE WE GO IN
WITH THE ASSUMPTION WE DON'T
HAVE ANY IDEA WHERE THIS
STIMULATION WILL BE BEST, MOST
EFFECTIVE FOR PEOPLE, WHAT THE
BIOMARKER WILL BE.
WE DO STIMULUS/RESPONSE MAPPING
STARTING WITH A WIDE SET AND
BASED ON ASSUMPTION WE SHY SEE
IMMEDIATE THERAPEUTIC EFFECTS
HONE DOWN TO A SMALLER NUMBER
AND EACH PERSON WE GET A SET OF
FINALISTS BY THE END OF THAT
WEEK THAT WE TEST IN MORE DEPTH
SO WE START OUT WITH BASICALLY A
SAFETY SCREEN TO FIGURE OUT
MAKING SURE WE CAN BE IN A RANGE
WITHOUT EPILEPTIC ACTIVITY, AT
LEAST TWO STIMES IN EACH
LOCATION UNLESS THERE'S NEGATIVE
EFFECT ELICITED.
THE BIOMARKER IS WE TAKE ALL
THAT DATA THAT WE COLLECT FROM
THE INTRACRANIAL EEGs AND DO
EXPLORATORY ANALYSIS WITH HIGH
STANDARD REQUIRING HUGE EFFECTS
NOT SEEN BY CHANCE AND COME OUT
WITH AN EFFECT -- A PERSONALIZED
STRATEGY AND PERSONALIZED
BIOMARKER THAT THEN GET VERIFIED
IN STAGE 2.
SO THAT'S SORT OF HOW WE GET TO
DIFFERENT STRATEGIES OF
DIFFERENT PEOPLE.
THERE WAS A SECOND QUESTION I
FORGOT.
>>JUST THE STABILITY OF
STIMULATION OVER TIME.
>>RIGHT.
SO WE OF COURSE DON'T KNOW THAT
IN ANY GREAT WAY.
I WOULD SAY SO FAR WE'VE SEEN
SUSTAINED BENEFIT HAPPENING FOR
PERIODS UP TO A YEAR.
WE HAD ONE COMPLICATED THING,
ONE OF OUR -- OUR FIRST PATIENT
GOT COVID, AND ALSO WHAT LOOKS
LIKE LONG -- IS A LONG HAUL,
WHICH IS A COMPLICATION, YOU
KNOW, YOU HOPE IS NOT GOING TO
HAPPEN.
BUT SHE CAN TELL DIFFERENCE
BETWEEN HER DEPRESSION AND
THERAPEUTIC STIMULATION AND BY
AND LARGE THE STIMULUS HAS
REMAINED THERAPEUTIC OVER TIME
BUT IT'S VERY CLEAR THAT WE HAVE
IMMEDIATE EFFECTS THAT WE CAN
SEE, REFLECTED IN POWER AND
COHERENCE AND THINGS LIKE THAT
PROBABLY ACTIVITY RELATED BUT
OVER THE LONG TERM IT'S CLEAR WE
GET CHANGES IN CIRCUIT
CONNECTIVITY, CAN SEE WITH
EVOKED POTENTIAL, THE CIRCUIT IS
CHANGES, MAY NEED TO BE UPDATED
BUT WE'RE JUST LEARNING THIS.
I THINK INSTABILITY IS THE
NATURE OF THE BRAIN.
IT'S AN ADAPTIVE ORGAN.
THE FACT THAT WE SEE EFFECTS
THAT ARE THERAPEUTIC THAT
SUSTAIN IS SURPRISING TO ME.
I WOULD HAVE EXPECTED WE WOULD
HAVE TO ADAPT MORE THAN WE HAVE
BUT WITH BIOMARKER IT LOOKS LIKE
WE'RE GOING TO HAVE TO ADAPT
MORE.
>>GREAT.
MAY EVEN BE A GOOD THING.
JIM, NICE TO SEE YOU AGAIN.
>>YOU TOO, CHRISTINE.
THANKS, DR. KRYSTAL.
REALLY QUITE INTERESTING.
YOU PARTIALLY ADDRESSED THIS IN
YOUR COMMENTS TO NITA, WONDERING
THERAPEUTIC EFFECT IS IT GRADED?
IT'S NOT THE SAME EACH TIME I
PRESUME.
HOW DO YOU MEASURE AND MAKE
SENSE OF ALL OF THAT?
>>SO ANOTHER COMPLICATED
QUESTION.
IN THE INITIAL PHASE WE HIT THE
CIRCUITRY I THINK PRETTY HARD
AND WE SEE PEOPLE SAYING LIKE
WOW, I FEEL THIS LIKE BETTER
FEELING, I FEEL MORE ENERGY,
MORE ALERT, OR I FEEL BAD, I
FEEL ANXIOUS BUT THEY FEEL BIG
EFFECT WAS EVERY STIMULUS.
WHEN WE GET TO WHERE WE
IMPLEMENT WE DON'T WANT PEOPLE
TO HAVE AN UP EVERY TIME THEY
GET STIMULATE AND IT DISRUPTS
THEIR LIFE NOT CONDUCIVE WITH
GOOD FUNCTION, WE'RE NOT TRYING
TO MAKE PEOPLE HAPPY, WE'RE
TRYING TO TAKE AWAY DEPRESSION
WHICH IS DIFFERENT.
HIGH INTENSITY STIMULATION LIKE
IN THE VENTRAL CAPSULE LIKE THE
FIRST PATIENT WE COULD MAKE HER
HAPPY BUT I COULDN'T LIVE THIS
WAY, I'M LIKE TOO -- IT'S LIKE
I'M HIGH, THERE'S A DISCUSSION
TO BE HAD AROUND THAT.
WHEN WE LOWERED TO BELOW, I JUST
FEEL GOOD, THE PROBLEM IS GONE.
WHEN GOOD THINGS HAPPEN SHE
FEELS BETTER, WHEN BAD THINGS
HAPPEN SHE FEELS WORSE.
WE DON'T WANT TO TAKE THAT WE.
CRITICAL ADAPTIVE FUNCTIONS THAT
HUMANS HAVE THAT ARE HUGELY
IMPORTANT FOR THEIR EFFECTIVE
LIFE.
SO IT'S MORE BASICALLY WHAT THE
PATIENTS SAY IS I JUST DON'T
FEEL THE DEPRESSION NOW.
IT'S NOT THAT OH, I KNOW I'M
BEING STIMULATED.
THEY THINK THEY KNOW AND ARE
USUALLY WRONG ONCE WE GET TO THE
SUBDETECTION LEVEL.
I HOPE THAT ANSWERS THE
QUESTION.
>>THANK YOU, IT DOES.
I WONDER THOUGH IN THE
CLOSED-LOOP SYSTEM THEN SHOULD
YOU GEAR IT TOWARDS HOW THE
PATIENT IS FEELING OR TO THE
BIOMARKER?
>>THIS IS A GREAT QUESTION.
WHAT HAPPENED IS WE DEVELOP A
BIOMARKER THAT'S AT THE LEVEL
OF -- THIS IS A GUESS -- AT THE
LEVEL OF WHAT CORRELATES WITH
THEIR SYMPTOM REPORT.
BUT THEN WHEN IT OPERATES, IT
SEEMS TO BE PICKING UP SOMETHING
AT A LEVEL THAT'S BEFORE THAT.
THEY DON'T HAVE TO HAVE A -- YOU
KNOW, LET'S SAY WE HAVE A VISUAL
ANALOG SCALE 0 TO 100, 0 IS
GREAT, 100 IS TERRIBLE, THEY
DON'T HAVE TO -- WHILE THE
BIOMARKER IS DEVELOPED WITH
RANGE OF SYMPTOMS THAT GO FROM 0
TO 100, IT SEEMS MORE THAT WHEN
IN OPERATION THEY STAY IN A
RANGE OF LIKE 0 TO 40, AND THEY
DON'T -- IT'S DOING SOMETHING
OVER TIME THAT'S NOT COMPLETELY
CLEAR TO ME THAT IS PICKING THIS
UP BEFORE THEIR SYMPTOMS, BEFORE
THEY GET AN EXPERIENCE THAT
LEADS TO INCREASED SCORES BUT
SOMEHOW MORE SENSITIVE TO THE
PROCESS, IT SEEMS LIKE, THAN I
WOULD HAVE ANTICIPATED.
THE OTHER POSSIBILITY IS THAT
THE BIOMARKER IS DOING NOTHING
AND THAT IT'S JUST DRIVING
INTERMITTENT STIMULATION AND
BECAUSE OF THAT POSSIBILITY
WE'RE ACTUALLY ADDING A THIRD
ARM TO STAGE 3 OF INTERMITTENT
STIMULATION VERSUS CLOSED LOOP
STIMULATION VERSUS SHAM.
BECAUSE IT IS POSSIBLE THAT IT'S
NOT RELATED TO THE PATHOLOGICAL
PROCESS AND THE BIOMARKER IS
MEASURING SOMETHING ELSE IT'S
CREATING INTERMITTENT STIM THAT
WORKS, THAT'S ANOTHER
POSSIBILITY.
>>VERY INTERESTING.
DR. LANGEVIN AND WE'LL MOVE ON.
OH, I SEE ANOTHER HAND.
WE'LL DO TWO SHORT QUESTIONS AND
MOVE TO THE NEXT SPEAKER.
>>WHICH ONE FIRST?
>>DR. LANGEVIN.
>>I THINK YOU WERE AHEAD OF ME.
>>I DIDN'T SEE THE HAND.
SORRY.
>>DON'T WORRY ABOUT IT.
GO AHEAD.
>>OKAY.
THANK YOU.
SO, MY QUESTION IS QUICK.
YOU DESCRIBED A PRETTY ROBUST
PLACEBO EFFECT WHICH IS NOT
SURPRISING, IN FACT IT WOULD BE
SURPRISING IF THERE WASN'T ONE
BUT I'M CURIOUS ABOUT WHEN
YOU'RE DOING YOUR
STIMULUS/RESPONSE MAPPING YOU
JUST DESCRIBED HOW DO YOU KNOW
YOU'RE NOT MAPPING TO A PLACEBO
RESPONSE?
>>SO, THIS IS A GREAT QUESTION.
IN THE FIRST PATIENT AND THIRD
PATIENT WE DIDN'T HAVE MUCH OF A
PLACEBO EFFECT AT ALL BUT IN THE
SECOND ONE WE DID.
THAT CAUSED COMPLICATIONS.
WHAT WE HAD TO DO WAS DOING MANY
MORE TRIALS TO CONVINCE
OURSELVES WE HAD SOMETHING
THERAPEUTIC.
IT WAS PRETTY CLEAR IN THE
10-DAY STIMULUS/RESPONSE PERIOD
THIS WAS HAPPENING BECAUSE WE DO
BLINDED SHAM STIMULATION AND
STARTED TO SEE THINGS NOT
REPLICATES AS WELL AS WITH THE
FIRST PERSON AND STARTED TO
DISCOVER THAT IT WAS HAPPENING
BECAUSE OF A GREATER SHAM
RESPONSE.
BASICALLY WE UPPED OUR N OF
TRIALS.
BUT THAT DID LEAD TO SIGNIFICANT
COMPLICATIONS IN THE NEXT STAGE.
THE OTHER THING THAT HAPPENS, I
THINK AS WE START TO DO
STIMULATION, YOU GET ADAPTATION
OF CIRCUITRY AND WE'RE TRYING
DIFFERENT THINGS, THAT YOU MAY
END UP WITH A PERSON HAVING SOME
SUSTAINED BENEFIT FROM THE
THINGS THAT WERE DONE BEFORE.
AND SO THAT LED US TO -- WE WERE
AT THE VERGE FOR THE SECOND
PATIENT WE GOT TO A STATE HAVING
DONE A NUMBER OF TRIALS WITH
CLOSED LOOP WHEN WE DID TRIALS
OF SHAM HE DID WAY BETTER THAN
HAD HE WHEN WE DID SHAM LIKE
BEFORE WE STARTED DOING CLOSED
LOOP.
AND SO THAT WAS CORRELATED WITH
CHANGES IN HIS EVOKED POTENTIAL
RESPONSES, EVEN HARDER TO TELL
WE DID FIND CONFIGURATION THAT
WAS BETTER THAN THE SHAM
RELIABLY, BY FAR, BUT WE HAD TO
KEEP PUSHING ON.
IT DOES CREATE SIGNIFICANT
CHALLENGES.
>>WHAT'S GOING ON IN
ACUPUNCTURE LITERATURE, 25 YEARS
OF EXPERIENCE ON STUFF LIKE
THAT, SO, YEAH, GOOD LUCK.
THIS IS CHALLENGING FOR SURE.
>>SAMEER, THANK YOU FOR
WAITING.
>>I HAVE A COUPLE QUESTIONS,
I'LL KEEP IT TO ONE FOR THE SAKE
OF TIME, MAYBE GET BACK TO THE
OTHER ONE IN THE DISCUSSION.
THANKS A LOT FOR THE GREAT TALK,
ENJOYED IT.
KIND OF FOLLOWING FROM THE VERY
END OF YOUR RESPONSE TO JIM'S
QUESTION, RESPONSE VERSUS
INTERMITTENT, PHILOSOPHICALLY
HOW YOU KIND OF THINK ABOUT
VARIOUS VARIATIONS FOR
NEUROMODULATION.
CLOSED LOOP, WE TALKED ABOUT
TREMOR, EPISODIC, SOMETIMES NOT
THERE, YOU DON'T NEED IT WHEN
YOU'RE NOT SHAKING, LIKE
DEPRESSION SLIPPING IN AND OUT
BUT PERIODS OF DEPRESSION CAN
LAST LONG PERIODS OF TIME.
THE DIAGNOSE IT ITSELF IS
DEFINED IN TEMPORAL WINDOWS SO
DO YOU THINK OF EPISODIC ILLNESS
THAT REQUIRES PUNCTUATED
TREATMENT LIKE TREMOR, AN ENGINE
BACKFIRING AND TRIGGER PTSD
VERSUS SOMETHING THERE ALL THE
TIME WHERE YOU NEED SOMETHING
THAT IS MAYBE CONTINUOUS, MAYBE
INTERMITTENT, REALLY INTERESTED
IN THAT INTERMITTENT EXPERIMENT.
MAYBE YOU DON'T NEED CONTINUOUS,
MAYBE YOU NEED TO PING THE
CIRCUIT PERIODICALLY, IS IT THAT
YOU'RE SLIPPING IN AND OUT OF
PERIODS, STATES OF DEPRESSIVE
SYMPTOMS WHERE YOU NEED TO BE
KICKED BACK OUT WITH STIMULATION
WHICH IS SOMETHING THAT REQUIRES
RESPONSIVE ADAPTIVE CLOSED LOOP
ET CETERA VERSUS OTHER
ALTERNATIVES.
>>GREAT QUESTION.
YOU RAISED A BUNCH OF QUESTIONS.
I'VE WORKED WITH DEPRESSION
PATIENTS FOR A LONG TIME, NEVER
UNTIL I STARTED TO DO THIS STUDY
AND STUDIES LIKE IT DID I GET AN
OPPORTUNITY TO BE WITH A
DEPRESSED PATIENT MOMENT TO
MOMENT, ACTUALLY TRYING TO
ASSESS SEVERITY OF THEIR
DEPRESSION.
WHAT WE FOUND IS THAT WE HAVE
SOME PEOPLE WHO WHILE BEING IN
AN EPISODE OF SEVERE TREATMENT
RESISTANT DEPRESSION HAVE
SUBSTANTIAL VARIATION OVER THE
SYMPTOMS, ONE OF OUR PATIENTS
VERY LITTLE VARIATION IS
EXTREMELY SEVERE AND SORT OF
FIXED BUT WHEN WE STARTED TO DO
STIMULATIONS AND EXPLORE EFFECTS
WE FOUND VARIATION IN THAT
INDIVIDUAL AS WELL, MAYBE
TRIGGERED BY THIS STIM PROCESS.
AND THE OTHER IS PEOPLE ARE
AFFECTED DIFFERENTLY BY HAVING
OTHERS IN THE ROOM.
YOU KNOW, YOU START TO GET THESE
RELATIONSHIPS AND EXPECTATION
EFFECTS, WE TRY TO NOT DRIVE
THAT SO WE SEE VARIATION.
AND IN DEPRESSION THERE'S A
HISTORY OF PROBLEMS THAT IF YOU
STIMULATE A PERSON WHO HAS
DEPRESSION WITH A TREATMENT WHEN
THEY ARE NOT DEPRESSED YOU HAVE
THE RISK OF TRIGGERING MANIA.
THAT CAN ALSO HAPPEN WHEN THEY
ARE DEPRESSED, FOR EXAMPLE,
ANTI-DEPRESSANT MEDS HAVE A
REASONABLE CHANCE OF TRIGGERING
MANIA SO WE DON'T USE THEM IN
BIPOLAR PATIENTS WITH DEPRESSION
BUT IN UNIPOLAR, DBS STUDIES
TRIGGERED MANIA SO STIMULATING
WHEN PEOPLE DON'T HAVE
DEPRESSION DOES RUN SOME DEGREE
OF RISK.
AND BUT I CAN'T SAY FOR SURE
THAT THAT'S NOT SOME SUBGROUP OF
PEOPLE, THAT IT WOULD BE OKAY TO
STIMULATE SOME PEOPLE ALL THE
TIME.
I THINK THE QUESTION OF THE
INTERMITTENT STIMULATION VERSUS
OPEN, I DO THINK THAT THERE IS
SOME DEGREE TO WHICH
INTERMITTENT STIMULATION WAS THE
RIGHT STRATEGY, HAS THERAPEUTIC
EFFECTS THAT PROBABLY ARE NOT
SPECIFICALLY CRITICAL TO BEING
BIOMARKER DRIVEN.
WHEN WE'RE -- BEFORE WE HAVE A
BIOMARKER WHEN WE'RE TRYING TO
TEST PARADIGMS WE DO SOME
INTERMITTENT STIMULATION AND SEE
LIKE IF YOU TIME IT RIGHT, THIS
IS AN OPEN AREA OF RESEARCH THAT
NEEDS TO BE DONE, YOU CAN GET
LONGER LASTING EFFECTS.
WE HAD EFFECTS FOR 3 HOURS IN
STIMULATING IN LIKE 5-SECOND
CHUNKS INTERMITTENTLY FOR SOME
PERIOD IN STAGE 1, ONE OF THE
PATIENTS I WAS TALKING ABOUT.
IT'S CLEAR THERE IS
INTERMITTENTCY EFFECT, ALSO WITH
CLOSED LOOP WE'RE SEEING CHANGES
IN CIRCUITRY WHICH LEAD TO
SUSTAINED BENEFIT OVER TIME SO I
THINK I MENTIONED BEFORE IF YOU
START STIMULATING THIS MAY NOT
BE TRUE IN OTHERS BUT FOR
DEPRESSION IF YOU START
STIMULATING AND SO FAR IN PEOPLE
WE'VE SEEN YOU GET AN EFFECT
THAT LASTS 30 MINUTES, 40
MINUTES, BUT AFTER WE'VE BEEN
DOING CLOSED LOOP FOR A BIT YOU
STOP STIMULATING AND GET BENEFIT
THAT LASTS 3 TO 5 DAYS, MAYBE A
WEEK IN ONE PERSON.
SO IT'S HARD TO CONCEPTUALLY
THINK ABOUT IT.
DOES IT NEED TO BE LINKED TO
BIOMARKER ONCE YOU HAVE BENEFIT
SUSTAINING FOR A WEEK?
I SUSPECT PROBABLY NOT BUT I
THINK IT NEEDS TO BE RIGOROUSLY
TESTED.
INTERMITTENTSY IS THERAPEUTIC,
OPEN QUESTIONS, LOTS OF WORK TO
BE DONE.
>>THANK YOU.
I HOPE YOU CAN STICK AROUND FOR
MORE DISCUSSION AFTER THE NEXT
SPEAKER.
THE SECOND SPEAKER WILL TALK
ABOUT INCORRECT OR MORE INDIRECT
METHOD OF AFFECTING THE BRAIN.
DR. VIVEK PANDRANGI, FOURTH YEAR
OTOLARYNGOLOGY RESIDENT AT
OREGON HEALTH AND SCIENCE
UNIVERSITY, COMPLETED
UNDERGRADUATE DEGREE IN BIOLOGY
AND ANTHROPOLOGY AT WASHINGTON
UNIVERSITY IN ST. LOUIS,
OBTAINED MEDICAL DEGREE AT
VIRGINIA COMMONWEALTH UNIVERSITY
OF SCHOOL OF MEDICINE, INVOLVED
IN RESEARCH EXPLORING USE OF
VIRTUAL REALITY IN THE MEDICAL
FIELD ALONG WITH HIS MENTOR DR.
RYAN LEE, ASSOCIATE PROFESSOR OF
OTOLARYNGOLOGY AND OHSU AND
TODAY WILL SPEAK TO US ON THE
EFFECT OF VIRTUAL REALITY ON
PAIN MANAGEMENT AND OPIOID USE.
THANK YOU, DR. PANDRANGI, FOR
BEING WITH US TODAY.
>>THANK YOU.
IT'S AN HONOR TO BE HERE.
LET ME SEE IF MY SLIDES ARE
SHARED.
THAT LOOKS OKAY.
>>LOOKS GOOD.
>>THANKS SO MUCH.
AGAIN, GOOD AFTERNOON AND THANK
YOU FOR THE OPPORTUNITY FOR US
TO PRESENT RESEARCH, AND I LOOK
FORWARD TO DISCUSSION
AFTERWARDS.
AGAIN, I'M VIVEK, I'LL BE
PRESENTING RESEARCH, EFFECT OF
VIRTUAL REALITY ON PAIN
MANAGEMENT AND OPIOID USE AMONG
HOSPITALIZED PATIENTS AFTER HEAD
AND NECK SURGERY, A RANDOMIZED
CLINICAL TRIAL.
AND I HAVE NO DISCLOSURES.
POSTOPERATIVE PAIN AFTER SURGERY
RECEIVED GROWING ATTENTION TO
IMPROVED FUNCTIONAL RECOVERY,
REDUCE HOSPITAL STAYS, IMPROVE
QUALITY OF LIFE.
BUT POOR POSTOPERATIVE PAIN
CONTROL CAN LEAD TO POOR
FUNCTIONAL RECOVERY, DISCHARGE
AND CHRONIC PAIN, BALANCED WITH
RISKS OF PAIN MEDICATION
PARTICULARLY NARCOTICS, A MAJOR
PART OF THE POSTOPERATIVE PAIN
MANAGEMENT PATHWAY WITH KNOWN
RISKS, NAUSEA, SEDATION,
DEPENDENCE, CONSTIPATION AND
MORE, AND THIS REPRESENTS STAYS
65 AND OLDER.
AS YOU CAN SEE FROM 2015 DATA,
OREGON WAS AN UNFORTUNATE LEADER
IN THIS.
MULTI-MODAL ANALGESIA IS AN AREA
OF EXPLORATION FOR OPTIMAL PAIN
CONTROL AND THESE APPROACHES
MINIMIZE USE OF NARCOTICS AND
PROVIDE STABLE RELIABLE PAIN
CONTROL, BUT A MAJOR CHALLENGE
OF IMPLEMENTING THIS ARE
PATIENTS' MEDICAL COMORBIDITIES.
A PATIENT WITH KIDNEY DISEASE OR
HIGH BLEEDING RISK MAY NOT BE A
GOOD CANDIDATE FOR NSAIDs LIKE
IBUPROFEN OR WITH LIVER
DYSFUNCTION AND ACETAMINOPHEN.
NOVEL AND COST EFFECTIVE
STRATEGIES COULD CONFRONT THIS
COMPLEX ISSUE.
VIRTUAL REALITY, VR, PROVIDES A
THREE DIMENSIONAL IMERSIVE
EXPERIENCE USED IN A VARIETY OF
HEALTH CARE SETTINGS INCLUDING
TREATMENT OF ANXIETY, PHYSICAL
REHABILITATION, INTERMITTENT
PROCEDURE DISTRACTION, EVEN PAIN
CONTROL.
YOU CAN SEE USERS WEAR A
HEAD-MOUNTED DISPLAY, HELMET
WITH MOTION TRACKER SO USERS CAN
MOVE THROUGH SIMULATED
ENVIRONMENT, HEADPHONES OR
SPEAKERS FOR SOUND TO FACILITATE
IMMERSION, AND SOME SORT OF
INPUT DEVICE, HAND-HELD
CONTROLLERS OR GLOVES EVEN TO
ENABLE INTERACTION WITH VIRTUAL
OPTIONS.
THE THOUGHT IS VR CAN OFFER
DISTRACTION THROUGH THE
MULTI-SENSORY OF AUDITORY,
VISUAL, PROPRIOCEPTIVE STIMULI.
THERE'S SIGNIFICANT CONTENT FOR
PATIENTS TO USE FROM DIFFERENT
MEDITATION TO EXPLORATION
EXPERIENCES, EVEN SOME ACTIVE
GAMING EXPERIENCES.
USE OF VR IS GAINING SIGNIFICANT
TRACTION IN MANY ACADEMIC
CENTERS, NUMEROUS PUBLICATIONS
OUT NOW ON VR AROUND 400
PUBLISHED IN 2010 COMPARED TO
3,000 ARTICLES PUBLISHED IN
2022.
I SHOULD ADD THAT ONE OF THE
MAIN LIMITATIONS IN CURRENT VR
LITERATURE IS LACK OF
COMPARATIVE CONTROL GROUPS
BECAUSE OF THE DIFFERENT
EXPERIENCES OFFERED IN VR
COMPARED TO TRADITIONAL MEDIA
PLATFORMS.
SOME STUDIES WOULD BE COMPARING
VR INTERVENTIONS TO EITHER
PASSIVELY VIEWING SOME SORT OF
MEDIA ON A 2D SCREEN, BUT THESE
CAN BE DIFFERENT AND CONFOUND
POTENTIAL BENEFITS FROM USE OF
VR.
AND THEN ON TOP OF THAT
LITERATURE SPECIFIC ON USE OF VR
IN POSTOPERATIVE MANAGEMENT IS
SPARSE.
BUT VR MAY SERVE AS BOTH MEANS
FOR NON-PHARMACOLOGIC PAIN
MANAGEMENT AND MEANS TO IMPROVE
PATIENT QUALITY OF LIFE IN THE
HOSPITAL, BOTH OF WHICH MAY
FACILITATE POSTOPERATIVE
RECOVERY.
SO THE PURPOSE OF THIS STUDY WAS
TO EVALUATE THE IMPACT OF AN
ACTIVE VR GAME COMPARED TO A
SIMILAR 2D GAME ON POSTOPERATIVE
PAIN AMONG PATIENTS HOSPITALIZED
AND HEAD AND NECK SURGEONRY TO
EVALUATE CHANGES IN SUBJECTIVE
PAIN SCORES AND SECONDARY AIMS
TO EVALUATE CHANGES IN OPIOID
UTILIZATION AND SUBJECTIVE
PATIENT EXPERIENCES WITH THEIR
INTERVENTION.
WE HYPOTHESIZE PATIENTS USING IT
WOULD HAVE LOWER SCORES COMPARED
TO CONTROL GROUP.
THIS IS FROM JULY OF 2020 TO
OCTOBER 2021.
APPROVED BY OHSU IRB, REGISTERED
ON clinicaltrials.gov,
NUMEROUS INCLUSION CRITERIA
LISTED HERE, PATIENTS WHO WERE
HOSPITALIZED AFTER HEAD AND NECK
SURGERY WERE ASKED TO
PARTICIPATE IF THEY HAD MODERATE
TO SEVERE PAIN DEFINED BY
AVERAGE OF PAIN SCORE FROM THEIR
MEDICAL RECORD OF 3 OR HIGHER IN
THE 24 HOURS PRIOR TO SCREENING
FOR STUDY ELIGIBILITY AND
ENGLISH SPEAKING, AS THAT IS
WHERE MOST CONTENT AVAILABLE ON
CURRENT PLATFORMS, LANGUAGE IS
AN OPTION FOR PATIENTS TO USE.
AND THEN WE ALSO HAD EXCLUSION
CRITERIA INCLUDING INTENSIVE
CARE UNIT STAY, ACTIVE
INFECTIONS, NAUSEA, VERTIGO,
SEIZURE DISORDERS, ALSO NOTABLY
POSTOPERATIVE LIMITATIONS SUCH
AS RECONSTRUCTIONS OR WOUND CARE
CONDITIONS THAT WOULD PREVENT
THE SAFE OR COMFORTABLE USE OF A
VR HEADSET.
NUMEROUS DEMOGRAPHICS INCLUDING
AGE, SELF-REPORTED SEX,
COMORBIDITIES, PREOPERATIVE
OPIOID USE, SURGICAL
CHARACTERISTICS, OPIOID USE WAS
MEASUREDS MILLIGRAM EQUIVALENT.
PATIENTS WERE RANDOMLY ASSIGNED
USING SOFTWARE-GENERATED
RANDOMIZATION TO VR INTERVENTION
OR CONTROL GROUP.
VR HEAD SET USED WAS OCULUS
QUEST, A SILICON HEADSET,
DISPOSABLE SANITARY COVERS, EYE
MASKS, FACE MASKS BEFORE USE TO
MINIMIZE DIRECT DEVICE CONTACT.
PATIENTS IN THIS GROUP VR GROUP
PARTICIPATED IN THE 15-MINUTE
INTERACTIVE GAMING EXPERIENCE,
ANGRY BIRDS, AS YOU CAN SEE IN
THE PICTURE HERE PATIENTS
UTILIZING THIS GAME, USING
CONTROLLERS, SITTING IN BED,
CONTENT IS INTERRUPTION FREE,
INCLUDES MUSIC, SOUND,
ANIMATION, AND MEANWHILE
PATIENTS IN THE CONTROL GROUP
PLAYED SIMILAR GAME, ANGRY BIRDS
2, SIMILARLY FOR 15 MINUTES ON
HAND-HELD SMARTPHONE DEVICES
WHILE SITTING IN BED WITH THE
AUDIO PLAYED THROUGH THE
SPEAKER.
ALTHOUGH THE TWO GAMES HAD
DIFFERENCES BASED ON THE
PLATFORM USE, THERE THEY WERE
SIMILAR IN THEMES, AUTOMATION,
AUDIO, GENERAL GAME PLAYED
STYLE.
PRIMARY OUTCOME WAS CHANGE IN
PAIN SCORE AFTER INTERVENTION
USE, SO PRIOR TO INTERVENTION
PATIENTS SELF-REPORTED PAIN ON
AN 11-POINT SCALE FROM 0-10,
EASY TO ADMINISTER, PATIENTS
REPEATED IMMEDIATELY AFTER AND
HOURLY 4 HOURS AFTER USE.
SECONDARY OUTCOMES INCLUDED
CHANGES IN OPIOID USE AND
PATIENT SATISFACTION WITH
INTERVENTION, ANALGESIC USE
INCLUDING OPIOID AND NON-OPIOID
DOCUMENTED FROM THE MEDICAL
REPORT 8 HOURS PRE-INTERVENTION
AND 8 HOURS POST INTERVENTION.
AND AFTER THE INTERVENTION
PARTICIPANTS WERE ASKED TO
COMPLETE RESPONSES TO TWO
QUESTIONS REGARDING THEIR
EXPERIENCE AND DESIRE TO USE
AUDIO/VISUAL INTERVENTION IN THE
FUTURE, THESE WERE RATED ON FIVE
POINT LIKERT SCALES WITH THE
FOLLOWING ANSWER CHOICES.
THIS WAS A PILOT STUDY, THERE'S
INEFFICIENT COMPARATIVE
PUBLISHED DATA AVAILABLE BEFORE
THE STUDY.
MEAN VALUES WITH STANDARD
DEVIATION, WITH INTERQUARTILE
RANGES, CONFIDENCE INTERVALS
REPORTED, P-VALUES RESULT OF
TWO-SIDED TESTS.
THE FIRST FIGURE, 30 PATIENTS
RANDOMIZED FOR INCLUSION, ONE
ABLE TO COMPLETE UTILIZATION OF
THE VR INTERVENTION DUE TO
DISCOMFORT IN USING THE PERSONAL
PROTECTIVE EQUIPMENT, SO THE
FINAL POPULATION INCLUDED 14
PATIENTS IN OUR VIRTUAL REALITY
COHORT, 15 IN THE CONTROL
COHORT.
THIS TABLE HERE DEMONSTRATES
CHARACTERISTICS, NO DIFFERENCES
BETWEEN THE TWO GROUPS, MAJORITY
OF PATIENTS WERE MALE, MEAN AGE
AROUND 58 YEARS, PRIMARY
SURGICAL SITES WERE ORAL CAVITY
AND ORAL PHARYNX, MAJORITY OF
SECONDARY SURGICAL SIDES
INCLUDED NECK.
FOR THOSE UNFAMILIAR WITH THE
FIELD, THESE PROCEDURES
PRIMARILY INVOLVED CANCER
RESECTIONS FROM DIFFERENT SITES
INCLUDING RESECTION OF REGIONAL
METASTATIC DISEASE THAT SPREAD
TO NECK AND SOME RESECTIONS ARE
RECONSTRUCTED USING TISSUE FROM
THE OTHER PARTS OF THE BODY SUCH
AS RADIAL FOREARM, FIBULA AND
OTHER SITES.
ALL PATIENTS HAD OPIOIDS
AVAILABLE TO THEM TO USE FOR
POSTOPERATIVE ANALGESIA.
WE FOUND NO DIFFERENCE IN
PRE-INTERVENTION BETWEEN THE TWO
GROUPS AND DIDN'T FIND
DIFFERENCE IN TIME TO
INTERVENTION AFTER MOST RECENT
OPIOID USE, PRE-INTERVENTION
PAIN SCORES, 4-HOUR OPIOID USE
OR 8-HOUR USE BETWEEN THE
GROUPS.
WE LOOK AT CHANGES IN PAIN
SCORES.
GRAPHICAL ANALYSIS IDENTIFIED
ONE EXTREME OUTLIER IN THE
CONTROL GROUP WITH
PRE-INTERVENTION PAIN SCORE OF 7
TO POST PAIN SCORE OF ZERO,
AFTER WE REMOVED THE OUTLIER
AMONG 28 FOUND A MEANINGFUL
REDUCTION IN PAIN REDUCTION IN
THE VIRTUAL REALITY GROUP
IMMEDIATELY AFTER THE
INTERVENTION USE COMPARED TO THE
CONTROL GROUP, 1.4 POINTS, ALSO
SOME RELATIVE DIFFERENCES IN ONE
HOUR, TWO HOURS, THREE HOURS
POST INTERVENTION PAIN SCORE
IMPROVEMENTS IN THE VIRTUAL
REALITY GROUP COMPARED TO
CONTROL GROUP, THIS DIDN'T
APPEAR TO PERSIST UNTIL 4-HOUR
MARK.
WE ALSO LOOKED AT CHANGES IN
OPIOID USE AFTER THE
INTERVENTION, AND WHAT WE FOUND
WAS A MEANINGFUL DECREASE IN
4-HOUR POST INTERVENTION OPIOID
USE COMPARED TO 4-HOUR
PRE-INTERVENTION OPIOID USE,
PATIENTS UTILIZING VR HEADSET,
MEAN DIFFERENCE AROUND 9 MME,
AROUND 1 TO 2.5 MILLIGRAMS
TABLETS OF OXYCODONE, A
DIFFERENCE AMONG VR PATIENTS
WITH MEAN DIFFERENCE AROUND 14
MME, ALMOST ONE 10-MILLIGRAM
TABLET OF OXYCODONE.
WE DIDN'T FIND DIFFERENCES IN
RESPONSE TO QUESTION OF I
ENJOYED MY AUDIO/VISUAL
EXPERIENCE OR WOULD LIKE TO SEE
MY AUDIO/VISUAL EXPERIENCE USED
MORE OFTEN IN HEALTH CARE, BOTH
COHORTS HAD HIGH RATINGS OF
ENJOYMENT OF THEIR
INTERVENTIONS.
NO ADVERSE EVENTS RELATED TO
INTERVENTION USE IN EITHER
COHORT IDENTIFIED.
IN THIS STUDY USE OF VR
INTERVENTION WAS ASSOCIATED WITH
MEANINGFUL REDUCTION IN PAIN AND
OPIOID USE COMPARED TO SIMILAR
2D INTERVENTION.
IMMERSIVE ENVIRONMENT MAY
EXPLAIN THE PAIN ATTENUATION
COMPARED TO TRADITIONAL
DISTRACTION SUCH AS 2D VIDEO OR
MEDIA.
THERE'S A RISE OF STUDIES, ONLY
A FEW HAVE AIMED TO EVALUATE USE
OF VR AFTER SURGERY, NONE HAVE
EVALUATED OUTCOMES ON OPIOID
UTILIZATION.
WE THINK THIS IS A SIGNIFICANT
FINDING THAT MAY ENCOURAGE
LARGER ADOPTION AND APPLICATION
OF VR EXPERIENCES FOR MANAGEMENT
OF POST-OPERATIVE PAIN.
NOW,IVE NOTE THERE DID NOT APAIR
TO BE A PAIN SCORE DIFFERENT
PERSISTING UP TO 4 4-HOUR MARK,
POST OPIOID UP TO 8 HOURS, THERE
MAY BE OTHER FACTORS ASIDE FROM
SUBJECTIVE PAIN INTENSITY
INFLUENCING USE AMONG PATIENTS,
IT'S SHOWN IN THE PAST VR HAS
BEEN BENEFITING TREATMENT OF
ANXIETY AND DEPRESSION SO IT'S
POSSIBLE THAT THERE MAY HAVE
BEEN A THERAPEUTIC EFFECT ON
ETIOLOGY ASIDE FROM SUBJECTIVE
PAIN, ASSOCIATED WITH THE
REDUCTION IN OPIOID UTILIZATION.
PATIENTS WHO UNDERGO HEAD AND
NECK SURGERY POSE UNIQUE
CHALLENGE TO THE USE OF VR DUE
TO INCISIONS OR RECONSTRUCTS
THAT MAY PRECLUDE USE OF WEARING
THE HEADSET OR PREVENT
COMFORTABLE OR SAFE USE OF VR IN
THE POSTOPERATIVE PERIOD.
SO FUTURE STUDIES ARE NECESSARY
TO BETTER UNDERSTAND THE RISKS
OF UTILIZING VR HEADSET IN
POSTOPERATIVE PERIOD AND DEFINE
INCLUSION CRITERIA FOR SURGICAL
PATIENTS.
THERE'S A PILOT STUDY WITH A
SMALL SAMPLE SIZE, 23% OF
PATIENTS WHO WERE APPROACHED FOR
RECRUITMENT DECLINED
PARTICIPATION, THERE MAY BE BIAS
IN ENROLLMENT FOR SELECTING
PATIENTS MORE LIKELY TO BENEFIT
FROM OR ENJOY GAMING EXPERIENCE.
THIS WAS A ONE-TIME VR USE, SO
NOVELTY OF THE USE AMONG
PATIENTS WITHOUT EXPOSURE TO THE
TECHNOLOGY MAY ALSO PLAY A ROLE.
SO QUICKLY A COUPLE FUTURE
DIRECTIONS TO CONSIDER HOW TO
FURTHER EVALUATE THIS TECHNOLOGY
FOR PATIENT CARE AROUND
ESPECIALLY IN OUR SURGICAL
CONTEXT, OF COURSE LARGER SCALE
STUDIES ARE NEEDED TO FURTHER
EVALUATE UTILIZATION AND
EFFICACY.
ADDITIONAL OUTCOMES ASIDE FROM
SUBJECTIVE PAIN SHOULD BE
CONSIDERED SUCH AS ANXIETY AND
DEPRESSION, WHICH CAN BE COMMON
IN THE PERIOPERATIVE PERIOD.
THERE SHOULD BE A COMPARISON OF
DIFFERENT TYPES OF EXPERIENCE
AND OUTCOMES.
OUR GROUP COMPARED MINDFULNESS
EXPERIENCE TO VR GAMING
EXPERIENCE ON PREOPERATIVE
ANXIETY AND POSTOPERATIVE PAIN,
MANUSCRIPT UNDER REVIEW.
OUR GROUP FINISHED A LARGER
TRIAL PROVIDING SIMILAR TO
SCHEDULED MEDICATION
HOSPITALIZED AFTER HEAD AND NECK
SURGERY, JUST ENDING AND WE'RE
BEGINNING THE DATA EVALUATION
PROCESS.
IN CONCLUSION VIRTUAL REALITY
WAS ASSOCIATED WITH REDUCED PAIN
SCORES HOURS AFTER INTERVENTION,
8 HOURS OPIOID, MAY BE A
USEFUL ADJUNCT FOR PAIN CONTROL
AFTER SURGERY.
>>I CAN'T WAIT TO HEAR THE
RESULTS OF THE REPEATED USE AND
ALSO GAMING VERSUS MEDITATION
USE, WHETHER THEY WERE
DIFFERENT.
DO PEOPLE HAVE QUESTIONS FOR DR.
PANDRANGI ABOUT THIS STUDY OR
USE OF VR IN PAIN CONTROL?
CAROLINE?
SO NICE TO HAVE YOU HERE.
ARE YOU THERE?
>>YEAH.
THANK YOU.
CAN YOU HEAR ME?
MAYBE NOT.
CAN YOU HEAR ME?
>>WE CAN HEAR YOU, YEP.
NOW WE CAN'T.
>>CAN YOU HEAR ME NOW?
>>I THINK YOUR SOUND IS COMING
IN AND OUT A LITTLE BIT.
>>OKAY, LET ME SEE.
IS THAT BETTER, CHRISTINE?
>>THAT IS BETTER.
YEP, THAT'S BETTER.
>>THANK YOU.
YEAH, THANK YOU, DR. PANDRANGI,
FOR THE INTERESTING TALK.
IN YOUR STUDY WHETHER YOU WERE
ABLE TO ASK SUBJECTS ABOUT THEIR
PRIOR EXPERIENCE OR EXPOSURE TO
VR PLATFORMS, I THINK YOU HAD
ALLUDED TO THAT A LITTLE BIT
EARLIER, ONE OF THE AREAS OF
INTEREST.
AND I WAS ALSO INTERESTED IN THE
QUESTION ALSO THAT CHRISTINE
JUST POSED ABOUT SOME OF PERHAPS
SOME EARLY RESULTS IN LOOKING AT
THE DIFFERENT CONDITIONS UNDER
WHICH YOU'RE TESTING SUBJECTS,
IN THE BEGINNING YOU MENTIONED
NOT ONLY GAMING BUT MEDITATION
AND NATURE BEING ANOTHER
CONDITION.
CURIOUS ABOUT THOSE
>>YEAH, IN RESPONSE TO THE
FIRST QUESTION, WE DIDN'T
FORMALLY LOOK AT THIS BUT JUST
FROM MY OWN AN ANECDOTAL
EXPERIENCE, USE OF VR IS GAINING
TRACTION, CONSUMER HEAD SETS ARE
OUT THERE, IT'S STILL NOT NEARLY
MAINSTREAM AT ALL.
FROM THIS ONE STUDY I'M PRETTY
SURE EVEN THOUGH WE DIDN'T
FORMALLY LOOK AT THIS, NO MORE
THAN ONE OR TWO PATIENTS HAVE
USED VIRTUAL REALITY BEFORE, SO
THAT WAS PART OF THE LEARNING
CURVE, I HADN'T USED IT BEFORE,
TEACHING THEM HOW TO USE IS,
PART OF THE IMPLEMENTATION
ASPECT, CHALLENGING, THOSE WHO
MAY NOT BE FAMILIAR, NOT
COMFORTABLE WITH TECHNOLOGY, FOR
EXAMPLE, BARRIER IS HIGHER.
SO I WOULD SURPRISED THAT A LOT
OF PEOPLE HAD NOT EVEN HEARD
ABOUT VIRTUAL REALITY BEFORE
EVEN THOUGH WE THINK IT'S SO
COMMON IN THE MEDIA AT THIS
TIME.
STILL A LOT OF OUR PATIENTS HAVE
NOT BUT THAT BEING SAID
INTERESTING THAT THEY WERE ABLE
TO PICK IT UP QUICKLY AND HAVE
THE BENEFITS THEY DID.
SIMILARLY IN SOME REPEATED
STUDIES A FEW OF MY PATIENTS
HAVE USED BEFORE BUT MOSTLY THEY
BOUGHT AS GIFTS FOR
GRANDCHILDREN OR KIDS OR
SOMETHING LIKE THAT AND THEY
THEMSELVES HADN'T REALLY TRIED
THEM BEFORE.
SO FROM AT LEAST MY OWN
EXPERIENCE USING THE VIRTUAL
REALITY IN HEALTH CARE WAS THE
FIRST TIME MAJORITY OF PATIENTS
HAD USED IT AND THAT BUILDS TO
THE STUDY WE JUST FINISHED,
PATIENTS GOT THE OPPORTUNITY TO
USE IT REPEATED IN THE
HOSPITALIZATION, COMBING THROUGH
DATA I FELT LIKE ONE OF THE
THINGS STARTING TO APPEAR IS
WHATEVER SUBJECTIVE PAIN BENEFIT
THEY MAY HAVE PERCEIVED MAY NOT
JUST BE JUST FROM THE NOVELTY
BUT MAY BE PERSISTENCE WITH THAT
DISTRACTION.
I'M STILL INTERESTED TO SEE HOW
LONG THAT DISTRACTION PERIOD
LASTS FOR.
IS IT REALLY JUST AN HOUR OR SO,
CAN IT BE LONGER, WE'LL HAVE TO
SEE HOW IT PARSES OUT.
THE OTHER DATA, WE LOOKED AT THE
IDEA OF MINDFULNESS EXPERIENCE
FROM BIOFEEDBACK WHICH I THINK
WILL BE REALLY IMPORTANT WITH
THE USE OF EMERGING VIRTUAL
REALITY TECHNOLOGY ESPECIALLY IN
FIELD OF ANXIETY, FOR
PREOPERATIVE ANXIETY AND FROM
EARLY DATA IT DOESN'T LOOK LIKE
TO BE HONEST THERE'S ANY
DIFFERENCE BETWEEN THE
INTERVENTION USED IN VIRTUAL
REALITY AND OUTCOMES WE'RE
FINDING.
AND THAT WAS SURPRISING TO ME AT
FIRST BECAUSE I -- PART OF ME
WAS THINKING IF SOMEONE'S
PARTICIPATING IN A GAME IT GRABS
YOUR ATTENTION MORE, THOUGHT
THEY WOULD HAVE REDUCED PAIN OR
ANXIETY, BASICALLY THE DATA IS
NOT SHOWING REAL DIFFERENCE BUT
THERE'S STILL BENEFIT FROM
PRE-INTERVENTION SCORES
SUGGESTING MAYBE BEING IN
VIRTUAL REALITY RATHER THAN
TARGETED INTERVENTION, AN
INTERESTING AREA TO LOOK MORE
AND MORE NOT JUST COMPARING
EXISTING TECHNOLOGIES AND
EXPERIENCES BUT AS WE HAVE TO
MOVE TOWARDS CREATING
TECHNOLOGIES THAT WILL BE GEARED
TOWARDS CERTAIN SPECIFIC PATIENT
POPULATIONS AND HEALTHCARE
SCENARIOS.
>>GREAT.
THANK YOU.
SEVERAL PEOPLE HAVE HANDS UP AND
A QUESTION IN THE CHAT.
WHY DON'T YOU GO WITH THE PEOPLE
ON THE SCREEN AND ASK WALTER'S
QUESTION, UNLESS WALTER WANTS TO
ASK HIMSELF.
SYD?
>>THANKS.
REALLY INTERESTING.
SO YOUR COMMENT YOU JUST MADE
ABOUT BIOFEEDBACK AND SO I'M
CURIOUS IF YOU WERE DOING ANY
MEASUREMENTS LIKE THAT FOR THE
PATIENTS OTHER THAN THE SORT OF
SUBJECTIVE MEASURES YOU WERE
USING ABOUT THEIR OWN PAIN
RATING, BUT I'M CURIOUS ABOUT
WHAT'S YOUR HYPOTHESIS ABOUT WHY
VR IS MORE EFFECTIVE THAN A 2D
DISTRACTION WOULD BE IN TERMS OF
RELIEVING SUBJECTIVE EXPERIENCE
OF PAIN.
>>GREAT QUESTION.
TO THE FIRST POINT, I HAVEN'T
LOOKED AT ANYTHING SPECIFICALLY,
WE WEREN'T LOOKING AT
BIOFEEDBACK BUT MEDITATION
APPLICATION WE USED, IT
ENCOURAGES BIOFEEDBACK AS PART
OF THE PLATFORM SO ONE THING
THAT I WANT TO CONSIDER FOR
FUTURE STUDIES IS ACTUALLY
RATHER THAN LOOKING AT JUST
ASSESSMENTS OF ANXIETY OR PAIN
BEFORE THEY PUT ON THE HEADSET,
AFTER IT COMES OFF FINDING A WAY
TO GET SCORES DURING USE AND
DURING DIFFERENT TIME POINTS OF
THEIR INTERVENTION TO GAUGE
BASED ON WHAT THEY ARE ACTUALLY
DOING IN VR HOW THAT'S IMPACTING
WHATEVER SCORES THEY MIGHT HAVE.
SO I THINK THAT'S AN IMPORTANT
POINT, SOMETHING TO THINK ABOUT
BECAUSE ANOTHER AREA TO LOOK AT
IS HOW LONG CAN PATIENTS BE IN
VR FOR, SO SO FAR MOST STUDIES
SUGGEST UP TO 30 MINUTES IS
FINE, SOME RISK OF CYBER
SICKNESS IS THERE, EYE STRAIN,
BUT SHORTER INTERVALS ARE
REALISTIC, 15 OR 20 MINUTES, AND
IF WE SEE EVERY 5 MINUTES
THERE'S OBJECTIVE EVALUATION WE
CAN GET ON SOME SORT OF NUMBERS
AND WE KNOW IN THAT EXPERIENCE
AT THE 7-MINUTE MARK IS WHERE
THEY ARE DOING BIOFEEDBACK THAT
LASTS FOR 2 MINUTES, COLLECTING
SCORES BEFORE THE ACTUAL
SPECIFIC MEASURES ARE BEING DONE
VERSUS SIMPLY BEING IN THE
VIRTUAL REALITY WORLD, THOSE
MORE NUANCED POINTS WILL COME
FROM FUTURE WORK.
REGARDING -- REPEAT YOUR SECOND
QUESTION.
>>YOUR HYPOTHESIS WHY VR IS
BETTER THAN 2D?
I THINK IMMERSION.
MY PATIENTS RECOVERING FROM
SURGERY, THERE'S SO MUCH GOING
ON AROUND THEM IN THE HOSPITAL
ROOM, THAT'S TAKING THEIR
ATTENTION, TALKING TO THEM,
TRYING TO FOCUS ON RECOVERY, SO
MUCH EXTRA NOISE FROM MACHINES,
HOSPITAL LIFE.
BUT WHEN YOU'RE IN THE HEADSET
AND IMMERSIVE ENVIRONMENT YOU'RE
NOT PATION -- PAYING ATTENTION.
YOU'RE FULLY IN THE VIRTUAL
REALITY WORLD, I THINK IT'S JUST
THE ATTENTION THAT YOU'RE FULLY
THERE IN THIS SPACE, PUTTING
YOUR ATTENTION THERE IS, TO ME,
THAT DISTRACTING ELEMENT
COMPARED TO HAVING AN iPHONE
OR 2D SCREEN YOU'RE STILL
SOAKING IN THE REST OF THE ROOM,
EVERYTHING ELSE AROUND YOU EVEN
THOUGH YOU'RE TRYING TO PAY
ATTENTION TO SOMETHING I DON'T
THINK IT'S THE SAME.
I THINK THAT'S REALLY WHERE VR'S
IMPACT IS.
>>THANK YOU.
DR. TED ABEL?
>>THANKS FOR AN INTERESTING
TALK.
I HAVE A QUESTION, ANDREW HAS
LEFT BUT A QUESTION FOR BOTH OF
YOU.
I'LL ASK FOR YOU.
IT HAS TO DO WITH PERSPECTIVE
FROM CIRCADIAN MEDICINE.
THIS IDEA FROM JOHN HOEINGENESH
AND OTHERS THAT TIMING OF TAKING
PILLS CAN IMPACT EFFICACY AND IN
THE CONTEXT OF PAIN THERE'S A
CIRCADIAN RHYTHM IN OUR -- I
DON'T KNOW IF IT'S SENSITIVITY
OR RESPONSIVENESS, NOTICING OF
PAIN.
I WONDERED IF YOU THOUGHT ABOUT
THAT, WOULD SEEM LIKE ONE
DIFFERENCE BETWEEN A PILL AND VR
IS YOU HAVE TO DO VR AT SOME
TIME, A PILL AT SOME TIME TOO
BUT IT CAN HAVE A LONGER
DURATION ACTION, THERE'S SOME
EVIDENCE PAIN -- YOU EXPERIENCE
MORE PAIN AT NIGHT, YOU DON'T
WANT TO WAKE SOMEBODY UP TO GIVE
THEM VR BUT GIVE THEM A PILL
BEFORE SLEEP.
>>THAT TIES INTO THE STUDY WE
JUST FINISHED TRYING TO USE
VIRTUAL REALITY SIMILAR TO
SCHEDULED MEDICATION, BRING IT
TO PATIENTS TO USE EVERY 4 TO 6
HOURS IN THE DAYTIME TO GET THEM
TO USE THAT.
I THINK THAT'S REALLY ONE OF THE
CHALLENGES OF VR COMPARED TO THE
PILL, AS THINGS ARE RIGHT NOW
REALLY TO SAFELY GIVE SOMEONE VR
WE NEED TO HAVE SOMEONE WATCHING
THEM, BEING AROUND THEM, WE HAVE
TO -- IF WE HAVE NOT A MEMBER OF
THE RESEARCH TEAM BUT NURSING
STAFF OR SOMEONE ELSE THERE,
THEY HAVE TO BE TRAINED IN VR,
UNDERSTAND THE RISKS, EVEN
THOUGH THEY ARE MINIMAL, AND I
THINK THAT INFRASTRUCTURE IS
LACKING RIGHT NOW TO BE ABLE TO
LOOK AT THOSE POINTS BECAUSE IN
AN IDEAL SETTING PATIENTS WOULD
HAVE THE HEAD SET IN THE ROOM,
WE ASK THEM TO USE IT A FEW
TIMES AND WE ENCOURAGE IT BUT WE
HAVE TO HAVE SOMEONE TO BRING IT
TO THEM, MONITOR THEM, HAVE THEM
USE IT, A CHALLENGING
PERSPECTIVE FROM A REGULATION
AND INFRASTRUCTURE STANDPOINT
THAT I THINK THAT'S HARDER TO
ASSESS BUT I THINK THAT HAS TO
HAPPEN BECAUSE SIMILARLY I WANT
THE PATIENTS TO USE IT
ESPECIALLY AT NIGHT BEFORE THEY
BOW TO SLEEP EVEN THOSE
MEDITATION ONES BECAUSE MY
THOUGHT IS THOSE WERE HELPFUL
WITH SLEEP AND PAIN, MAYBE
CONFOUNDING MIGHT HELP IN
OUTCOMES BUT I DON'T THINK WE'RE
THERE FROM IMPLEMENTATION
STANDPOINT THAT LET US DO THAT.
THAT'S ONE OF THE PROBLEMS THAT
I HOPE GETS SOLVED IN THE NEXT
FOUR TO FIVE YEARS, DEVELOPING
HOSPITAL-BASED PROTOCOLS USING
VIRTUAL REALITY TO MAKE THIS
PART OF THE SYSTEM.
>>THERE'S A WILDER OLDER STUDY
WHERE THEY HAVE DONE THIS THING
TRYING TO REACTIVATE MEMORY
DURING SLEEP WHICH IS WILD, WITH
ODORS PRESENT AT THE TIME OF
LEARNING.
YOU CAN MAJOR PAIRING SOMETHING
WITH THE VR EXPERIENCE AND USE
THAT TO QUOTE/UNQUOTE TO REPLAY.
YOU'LL THINK I'VE LOST MY MIND.
I PROMISE YOU I HAVE NOT.
>>GREAT STORY.
>>THERE'S A BUNCH OF
NEUROMARKETING COMPANIES
CIRCLING AROUND INCUBATING
DREAMS.
IT'S A TECHNIQUE PEOPLE ARE
TRYING TO PAIR TOGETHER.
>>EXACTLY.
I DON'T KNOW IF WALTER WANTS TO
ASK HIM QUESTION OR MAYBE I CAN
INSERT IT.
HE WANTS TO KNOW ABOUT POTENTIAL
MISUSE OF VR, ARE THERE
CONCERNS, HOW WOULD YOU CLASSIFY
THEM?
>>INTERESTING QUESTION.
SOMEBODY IS PUTTING ON A
HEADSET, TRYING IT, BUT THAT'S
THEIR INTRODUCTION TO THE
EXPERIENCE.
MAYBE ON THE MISUSE SIDE THEY
DON'T KNOW WHAT THEY ARE GETTING
INTO UNTIL THEY ARE DOING IT
BASICALLY.
SO I THINK THAT COMES DOWN TO
EQUAL INFORMED CONSENT APPROACH
WHERE DO YOU YOUR BEST TO TELL
THE PATIENT WHAT TO EXPECT FROM
THE EXPERIENCE AND THEY CAN STOP
AT ANY TIME BUT THAT COMES INTO
THEN BEING AS DESCRIPTIVE AS YOU
CAN WITH WHAT THEY ARE GOING TO
BE GOING THROUGH AND, AGAIN,
MOST OF THESE -- IT'S HARD TO
CLASSIFY HOW PATIENTS WILL
INTERACT WITH WHAT THEY ARE
GOING THROUGH, YOU MAY THINK
SOMETHING IS PRETTY STANDARD,
ANGRY BIRDS GAME, THIS IS GOING
TO BE FINE FOR MOST PEOPLE, BUT
YOU NEVER KNOW, THERE CAN BE
SOMEONE WHO THAT TRIGGERS
SOMETHING AND THAT BECOMES AN
UNFORTUNATE OCCURRENCE AND SO AS
OF RIGHT NOW THE BEST I THOUGHT
ABOUT OF IT HOW TO BE AS
DETAILED AS POSSIBLE, SHOW
PICTURES TO ACCLIMATE THEM BUT
THAT'S A CHALLENGE, THEY WON'T
KNOW WHAT IT'S LIKE UNTIL THEY
ARE IN THERE.
YOU CAN ONLY DESCRIBE IT SO
WELL.
>>THANK YOU.
KAREN?
>>THANKS FOR THAT GREAT
PRESENTATION.
GREAT TO SEE EVERYBODY.
EVEN IF WE COULDN'T MEET IN
PERSON.
DR. PANDRANGI, I'M CURIOUS WHAT
YOUR CONSIDERATIONS WERE IN
PICKING THAT PARTICULAR DEVICE,
PICKING THOSE GAMES, AND I'M
SORRY IF YOU MENTIONED IT BUT
THE REASON I BRING IT UP IS IT
SEEMS THOSE WHO WORK IN LOOKING
AT THERAPEUTIC APPLICATIONS FOR
GAMING ARE REALLY FINDING IT
DIFFICULT TO DRAW COMPARISONS IN
THE FIELD BECAUSE THE GAMES ARE
SO DIFFERENT.
ALSO RELATED TO TECHNOLOGY
ITSELF, OFTEN CONSIDERATIONS ARE
LESS SCIENTIFIC AND MORE AROUND
CONVENIENCE, THAT DOESN'T MEAN
IT'S UNETHICAL, SOMETIMES IT
LEADS TO GREATER ACCESSIBILITY,
CURIOUS IF YOU COULD SHARE MORE
ABOUT THE DECISION-MAKING
PROCESS.
>>YEAH, AT THE TIME OF DOING
THE STUDY THE MAINSTREAM
HEADSET, CONSUMER HEADSET WAS
OCULUS QUEST.
OUR GOAL WAS TO USE SOMETHING
CONSUMER FACING, EASIER TO USE
THEORETICALLY THAN WHAT IS BEING
BROUGHT ABOUT FROM THE HEALTH
CARE SPACES, ALSO SOMETHING THAT
COULD BE COST EFFECTIVE IF WE'RE
THINKING HOW TO IMPLEMENT THIS
LIKE A MEDICATION, HEAD SETS IS
AROUND $400, IF YOU HAVE
SANITARY PROCESS, YOU BUY A GAME
TO REUSE FOR EVERY PATIENT,
UNLESS IT'S STANDARD OF PRACTICE
IN THE HOSPITAL, YOU DON'T NEED
A NEW HEADSET FOR EVERY TIME YOU
USE VR, YOU HAVE ONE, $500, THE
COST GOES AWAY PRETTY QUICKLY.
WE WANTED TO USE SOMETHING
CONSUMER FACING LIKE THAT AND
KNOWING THAT WOULD MAKE IT
EASIER TO TRAIN PATIENTS TO USE
VR BECAUSE IT'S EASIER FROM THAT
STANDPOINT.
IN TERMS OF THE ACTUAL
INTERVENTIONS, IT TOOK A LOT OF
RESEARCH AND ESSENTIALLY CAME
DOWN TO ME REALIZING THERE'S SO
LITTLE COMPARATIVE EXPERIENCES
IN WHAT'S OFFERED IN VR SPACES
VERSUS 2D SPACES.
WE WANTED TO USE A GAME BECAUSE
I WANTED SOMETHING MORE
DISTRACTING, SOME OTHER STUDIES
SAID IF YOU'RE DOING GAMING IT'S
GOING TO GETTINGS MORE BUT HOW
DO YOU FIND SOMETHING THAT'S
COMPARABLE AND FROM MY EARLIER
RESEARCH I COULDN'T FIND
ANYTHING IN THE LITERATURE THAT
HAD TRIED -- BEEN ABLE TO DO
BECAUSE THERE ISN'T THAT
COMPARISON.
I JUST THINK IT'S MORE LUCK AND
CHANCE THAT REALLY ONE OF THE
GAMES SO POPULAR IS ANGRY BIRDS
AND BECAUSE OF THAT THEY HAD
CREATED A VIRTUAL REALITY GAME.
SO AT LEAST BEING ABLE TO DO
THAT BOTH THE GAMES ON THE PHONE
AND IN VIRTUAL REALITY IT'S
REALLY THE SAME ANIMATION,
SOUNDS, CRITICAL THINKING HOW
YOU PROGRESS THROUGH A GAME.
BASICALLY HELPS MINIMIZE FACTORS
BETWEEN VR AND THE PHONE, SOME
MORE DIFFERENCES COME TO NOW
YOU'RE IN A 3D WORLD VERSUS ON
YOUR SCREEN, USING CONTROLLERS
TO FLING THINGS IN THE VIRTUAL
SPACE SO IT BRINGS
PROPRIOCEPTION DIFFERENCES AND
THAT SPATIAL DIFFERENCES THAT
COME WITH VR AND HOPEFULLY MAKE
IT MORE SO IT'S LOOKING AT THE
IMPACT OF VR SPECIFICALLY THAN
JUST WHAT WE'RE DOING IN VR.
SO THAT'S CHALLENGING, STILL A
BIG CHALLENGE FOR LITERATURE,
AND CURRENT RESEARCH PRACTICES,
BUT MY THOUGHT IS NOW BASED ON
THIS STUDY AND SOME OF OUR OTHER
STUDIES THAT I'M MORE AND MORE
OF THE LEARNING THAT I DON'T
NECESSARILY THINK THAT IT
MATTERS WHAT PATIENTS DO IN VR.
I DON'T NECESSARILY THINK THE
EXACT EXPERIENCE CARRIES THAT
MUCH WEIGHT RATHER THAN JUST
BEING IN THAT SPACE AND DOING
SOMETHING THEY WANT TO DO IN VR.
SO OUR LAST STUDY WE UTILIZED
APPLIED VR, A COMPANY THAT HAS A
CATALOG OF EXPERIENCES PATIENTS
CAN DO FROM GAMES TO MEDITATION
TO SEEING DIFFERENT THINGS, AND
WE LET PATIENTS CHOOSE WHATEVER
THEY WANT AND I THINK THAT'S
WHERE THINGS ARE MOVING TOWARDS
BECAUSE I THINK IF THEY CHOOSE
IT THEY ARE GOING TO GET MORE
BENEFIT, IT WILL BE MORE
ENGAGING FOR THEM AND MAY NOT BE
THAT I NEED THEM TO DO A GAME TO
GET MORE PAIN CONTROL OR NEED
THEM TO DO MEDITATION BUT
PERHAPS THEIR OWN WISHES WILL
HELP WITH THAT PROCESS.
>>INTERESTING.
JIM?
THANK YOU.
I HAVE A LONGER QUESTION, THAT
HAS TO DO WITH PATIENT CONSENT,
SINCE THE 3D VIRTUAL REALITY IS
DIFFERENT FROM 2D, THE PATIENT
MUST HAVE BEEN TOLD DIFFERENCE
THINGS, I WONTEDDER IF THEY WERE
TOLD ABOUT EXPECTATION, VIRTUAL
REALITY IS NOVEL, PROBABLY 2D
GAMING EXPERIENCE MANY HAD
PROBABLY ALREADY EXPERIENCED, SO
THINKING ABOUT THE THERAPEUTIC
BENEFIT IS IT RELATED TO ASPECTS
OF NOVELTY WHERE PATIENTS
EXPECT, AND IN PARTICULAR I'M
INTERESTED IN THIS FROM THE
LONGER TERM OPIATE EFFECT, WHAT
PATHWAY MIGHT BE IMPACTED BY
THIS DISTINCTION THAT WOULD
ALLOW FOR LONG-TERM EFFECT ON
OPIATE USE?
>>GOOD POINT, RAISES SEVERAL
IMPORTANT CONSIDERATIONS, ONE IS
THE FACT THIS IS HARD TO BLIND
PATIENTS TOWARDS WHAT THE
INTERVENTION IS BECAUSE THEY ARE
GOING TO KNOW IF THEY ARE DOING
VIRTUAL REALITY OR NOT.
YOU CAN'T DO A SHAM.
BUT MOST PATIENTS SURPRISINGLY
GIVEN OUR POPULATION, MOSTLY
CANCER PATIENTS, A LOT ARE
OLDER, A LOT OF THEM DON'T HAVE
THAT MUCH GAMING EXPERIENCE.
I DIDN'T FIND A BIG DIFFERENCE,
STILL EXPLAINING THE SAME
MECHANICS TO BOTH, BUT
ESSENTIALLY I HAD TO LEAVE IT,
WE'RE DOING DIFFERENT
AUDIO/VISUAL EXPERIENCES,
RANDOMIZED TO THIS GROUP, I
TRIED TO EXPLAIN VR SHOWING
PICTURES OF THE HEADSET BUT IT'S
CHALLENGING BECAUSE IT'S
DIFFERENT IF SOMEONE HAS NOT
USED VR BEFORE.
THE NOVELTY WAS AN IMPORTANT
CONSIDERATION BECAUSE, AGAIN,
MOST HADN'T USED IT BEFORE BUT
IN SOME FOLLOW-UP STUDIES
REPEATING USE OF VIRTUAL REALITY
I THINK WE'VE DONE WELL TO
ADDRESS THAT AND I DON'T THINK
THE NOVELTY CARRIES AS MUCH
WEIGHT AS I THOUGHT BECAUSE I
STILL THINK FOR A LOT OF THESE
PATIENTS EVEN THOUGH IT MAY BE
NOVEL IT'S NOT AN EASY
INTERVENTION BY ANY MEANS.
IT'S CUMBERSOME TO PUT ON THE
HEAD SET, USE CONTROLLERS, EVEN
THOUGH IT'S A NOVEL EXPERIENCE I
THINK IT'S HARDER TO USE AND USE
WELL THAN A SIMPLE HANDHELD GAME
AND I THINK WHEN I STARTED
WATCHING PATIENTS DO THAT SOME
OF THAT STRUGGLE AND LEARNING
CURVE I WOULD HAVE THOUGHT MAY
HAVE DONE SOME OF THE OPPOSITE,
YOU HAVE TO LEARN HOW TO USE A
NEW THING THEY ARE NOT USED TO
RATHER THAN JUST BEING ABLE TO
SAY, WOW, I'M IN THIS 3D WORLD.
SO I THINK IT SOMETIMES CAN WORK
AGAINST VR WITH THAT LEARNING
CURVE AND HOW CUMBERSOME IT IS.
IN TERMS OF WHERE I THINK THE
OPIOID PATH COMES FROM, I THINK
IT'S INTERESTING BECAUSE I THINK
THAT MORE AND MORE WE'RE
LEARNING HOW TO SEPARATE
SUBJECTIVE PAIN AND FEELING OF
PAIN FROM ACTUAL USING OPIATE
MEDICATIONS, WHETHER THAT
SUBJECTIVE FEELING OF PAIN IS
TRULY PAIN DERIVED THAT YOU NEED
MEDICATION TO TREAT OR IS IT
ACCUMULATION OF BOREDOM,
ANXIETY, AS YOU'RE RECOVERING
FROM A SIGNIFICANT SURGERY, AND
SO MOVING -- I'M STARTING TO GET
THE SENSE OF MOVING AWAY FROM
THESE SUBJECTIVE PAIN SCALES
THAT MAY NOT REALLY BE OBJECTIVE
MEASURES OF PAIN WHEREAS OPIOID
USE MAY BE OBJECTIVE BECAUSE
SOMEONE'S TREATING PAIN WITH
MEDICATION RATHER THAN SOMEONE
SAYING 7 OUT OF 10 ON A PAIN
SCALE, WHAT ELSE ARE THEY
FEELING IN TERMS OF ANXIETY AND
STRESS AND I'M STARTING TO SEE
MORE OF THAT PSYCHOSOCIAL STUFF
PLAY A ROLE, THAT'S WHERE I'M
ALSO INTERESTED SEEING HOW WE
CAN WORK TOWARDS SEPARATING THAT
WITH ACTUAL PHYSICAL PAIN AND
NEED FOR PAIN MEDICATION TO
TREAT THAT PAIN AFTER SURGERY.
>>WE ARE GOING TO TAKE BREAK
BUT I'D LIKE TO ASK YOU ONE LAST
QUESTION BEFORE WE DO, DR.
PANDRANGI.
IN YOUR EXPERIENCE WHAT ARE THE
ETHICAL QUESTIONS OR CHALLENGES
THAT HAVE BEEN SORT OF FACING
YOU IN THESE EXPERIMENTS?
ANYTHING THAT STANDS OUT?
>>YEAH, THERE ARE A FEW.
I THINK ONE IS CHALLENGING,
AGAIN FROM MY PERSPECTIVE IN
HEAD AND NECK SURGERY, PATIENT
INCLUSION AND EXCLUSION.
IT'S TOUGH BECAUSE IF WE'RE
STARTING TO SEE ALL THIS BENEFIT
FROM THIS TECHNOLOGY, START
SAYING, WOW, THIS CAN HELP
PATIENTS IN SOME WAY, HOW MANY
PATIENTS HAVE I HAD TO EXCLUDE
SIMPLY BECAUSE WE DIDN'T FEEL
SAFE USING THIS TECHNOLOGY IN
POSTOPERATIVE CARE.
A LOT OF PATIENTS HAVE WOUND
INCISIONS ON THE HEADS,
THEORETICAL RISK THAT WE DON'T
WANT THE PRESSURE OF THE HEADSET
ON THOSE INCISIONS IN THE OFF
CHANCE IT CAUSES WOUND
BREAKDOWN, THAT WOULD BE ITS OWN
THING BUT THERE'S NO DATA THAT I
CAN FIND THAT HELPS US GAUGE HOW
MUCH PRESSURE, HOW LIGHT THE
HEADSET IF WE'RE RAMPING UP USE,
NEEDS TO BE ADDRESSED, AND OTHER
TYPE OF HEAD SETS, HOW MUCH
PRESSURE IS APPLIED ON FACE,
NASAL BRIDGE, ALL THE PLACES
WE'RE OPERATING ON BECAUSE WE'RE
EXCLUDING A FAIR AMOUNT OF OUR
PATIENTS SIMPLY BECAUSE OF WHERE
THE SURGERY WAS, ONE FRUSTRATING
CHALLENGE.
THE OTHER PART OF IT, WE'VE BEEN
USING CONSUMER TECHNOLOGY, EVEN
WITH HEALTH CARE RELATED
TECHNOLOGY, IT'S GEARED TO
PEOPLE ENGLISH SPEAKING, SO THE
PATIENTS WE HAVE EXCLUDE A
SIGNIFICANT SPANISH-SPEAKING
POPULATIONS, CAN'T USE THE
TECHNOLOGIES EITHER, THOSE ARE
BEEN TWO OF THE MAIN THINGS THAT
COME TO MIND WITH STUDIES.
THEORETICAL RISK OF SEIZURES,
BUT THE RISK IS LOW, YOU KNOW AS
PEOPLE ARE TRYING TO CREATE
VIRTUAL REALITY HEAD SETS OR
EXPERIENCES GEARED TO HEALTH
CARE, I THINK IT'S IMPORTANT TO
START LOOKING AT HOW YOU
MINIMIZE RISKS TO PATIENTS BASED
ON WHAT YOU'RE CREATING COULD
YOU COULD HAVE SOMETHING
STANDARDIZED A WIDER GROUP CAN
UTILIZE.
>>THANK YOU VERY MUCH.
WE'RE GOING TO TAKE A BREAK
UNTIL 2:00, RIGHT, NITA?
AND EVERYBODY PLEASE COME BACK,
RIGHT AT 2:00 SO WE CAN DIVE
INTO THE DISCUSSION.
THANK YOU SO MUCH FOR JOINING
US, DR. PANDRANGI.
>>MAYBE WE CAN START BY
ADDRESSING SOME OF THE QUESTIONS
THAT NITA THOUGHTFULLY SENT OUT
AHEAD OF TIME.
YOU KNOW, TALKING AMONGST
OURSELVES ABOUT WHAT ARE THE
ETHICAL QUESTIONS RAISED BY SOME
OF THESE TECHNOLOGIES,
HEALTH-RELATED TECHNOLOGIES THAT
AFFECT THE BRAIN?
THE TWO WE HEARD ABOUT ARE USED
FOR CLINICAL PURPOSES BUT WE CAN
IMAGINE CERTAINLY THE LATTER
ONE, MAYBE THE FORMER ONE MAYBE
SOME DAY, MAYBE FOR ANYONE
CLINICAL PURPOSE, WHAT ARE THE
ETHICAL CHALLENGES WE SHOULD BE
TALKING ABOUT, THINKING ABOUT,
WORRYING ABOUT?
DOES IT MATTER WHETHER THE
TECHNOLOGIES ARE DIRECT OR
INDIRECT?
AS WERE EXEMPLIFIED AND ARE
THERE ADDITIONAL CONSIDERATIONS
IF WE USE THESE TECHNOLOGIES IN
PEOPLE CONSIDERED VULNERABLE.
LET'S START WITH THAT AND THEN
WE'RE GOING TO SEGUE INTO
DISCUSSING WHAT IN PARTICULAR
NEWG SHOULD DO ON THESE
QUESTIONS.
AND, AGAIN, THANKS TO NITA FOR
THESE QUESTIONS.
WHAT'S THE APPROPRIATE
CONTRIBUTION OF NEWG, SCOPE,
LET'S START WITH FRAMING ETHICAL
QUESTIONS.
BOTH PRESENTATIONS WE HAD WERE
VERY INTERESTING AND VERY --
RAISED REALLY INTERESTING
QUESTIONS ABOUT THE KINDS OF
EFFECTS THAT WE CAN HAVE ON THE
BRAIN RIGHT NOW.
SO, WHAT ARE THE ETHICAL
QUESTIONS THAT YOU ALL SEE IN
TERMS OF THESE, THE USE OF THESE
KINDS OF TECHNOLOGIES THAT WE
SHOULD BE TALKING ABOUT?
WINSTON?
CAN'T HEAR YOU, WINSTON.
NO.
WE HEAR A SQUIGGLE BUT IT'S NOT
YOUR VOICE.
>>TRY SELECTING YOUR AUDIO ON
ZOOM AND RECONNECTING.
IF THAT DOESN'T WORK YOU MIGHT
HAVE TO REJOIN.
LIKE CLOSE AND REJOIN THE
MEETING.
>>SOUNDS LIKE HELIUM IS IN THE
ROOM.
>>EXACTLY.
>>WHILE YOU'RE WORKING ON THAT
I'LL GO TO JIM AND COME BACK TO
YOU WHEN YOU'RE READY.
GO AHEAD, JIM.
>>THANKS.
BOTH WERE INTERESTING
PRESENTATIONS, HIGHLIGHTING ONE
DISTINCTION THAT'S I THINK
IMPORTANT FOR ME ANYWAYS.
AND IT'S NOT SO MUCH THE DIRECT
VERSUS INDIRECT BUT IT'S MORE
HOW EASILY REVERSIBLE SOMETHING
IS.
SO, WITH IMPLANTATION, OBVIOUSLY
THAT'S A DIRECT INTERVENTION
THAT REALLY CAN'T BE REVERSED.
YOU CAN TAKE AN ELECTRODE OUT,
TAKE STIMULATING ELECTRODE OUT,
BUT FOR THE VR BY VIRTUE OF HOW
IT WORKS, WE REALLY DON'T KNOW
HOW IT REALLY WORKS BUT IF
OPIATE EFFECT IS REMODULATING
NEURAL CONNECTIVITY, LONG-TERM
VR EFFECTS, ACUTE EFFECTS, BUT
BY VIRTUE OF CAUSING A CHANGE IN
ADULT NEURONAL RESPONSIVENESS,
THAT TELLS YOU IT HAS TO BE
REVERSIBLE, EVEN IF WE DON'T
KNOW HOW TO REVERSIBLE.
FOR ME A DISTINGUISHING FEATURE
IS HOW EASILY REVERSIBLE
SOMETHING IS, VERSUS NOT
REVERSIBLE.
>>THAT'S A REALLY IMPORTANT
POINT.
THERE'S ANOTHER QUESTION
ABOUT -- FOR BOTH MODALITIES,
THE MEASURED EFFECT WAS
RELATIVELY SHORT TERM BUT WE
DON'T KNOW THAT'S THE ONLY
EFFECT THAT THOSE ARE HAVING.
JOHN AND THEN WINSTON.
>>IF I COULD AMPLIFY IT
UNDERSCORES IMPORTANCE OF
UNDERSTANDING MECHANISM BECAUSE
WE DON'T -- WE'RE NOT GOING TO
HAVE A WAY OF UNDERSTANDING WHAT
THE LONG TERM CONSEQUENCES WILL
BE WHEN YOU'RE USING THERAPY,
WHAT HAPPENS WHEN YOU WITHDRAW,
IF WE DON'T UNDERSTAND THE
UNDERLYING MECHANISM AT ANY
LEVEL, MOLECULAR, CELLULAR,
SYSTEM CIRCUITS, WHAT HAVE YOU,
SOMETHING WE SHOULD KEEP TOP OF
MINE.
>>I AGREE.
IS DR. PANDRANGI STILL ON WITH
US?
I DON'T THINK SO.
>>NO, HE HAD TO LEAVE FOR THE
OPERATING ROOM.
>>OKAY.
I WAS GOING TO ASK IF THEY ARE
MEASURING ANYTHING BEYOND
SUBJECTIVE EFFECTS BUT DOESN'T
SOUND LIKE IT.
WINSTON, ARE YOU WITH US?
>>I DON'T KNOW, CAN YOU HEAR ME
NOW?
DO I SOUND LIKE MYSELF AGAIN?
>>YOU SOUND LIKE YOURSELF.
>>I WAS STRUGGLING WITH THE
SCOPE OF TECHNOLOGIES THAT
AFFECT THE BRAIN.
NITA SAID AT THE BEGINNING
EVERYTHING THAT AFFECTS BRAIN,
MAYBE NOT EVERYTHING, BUT MOST
OF THE THINGS THAT IMPACT THE
BRAIN BY DIFFERENT MECHANISMS,
THE TWO THINGS WE HEARD ABOUT
WERE QUITE DIFFERENT IN TERMS OF
HOW EFFECTS WERE DELIVERED AND
SO I GUESS I WAS STRUGGLING TO
GET MY ARMS AROUND WHAT IS THE
SCOPE OF THE QUESTION THAT'S
BEING ASKED HERE.
I THINK WE CAN TAKE THESE AS TWO
EXAMPLES BUT OUR ABILITY TO
GENERATE EXAMPLES DEPENDING ON
WHAT WE CONSIDER UNDER THE
HEADING OF TECHNOLOGY, WHAT
EFFECTS ON THE BRAIN WE THINK
WE'RE INTERESTED IN, JUST
BECAUSE, YOU KNOW, ANYWAY THE
BOUNDARIES OF BOTH OF THOSE SEEM
VERY BLURRY TO ME.
MAYBE ONE GOAL, I MIGHT HAVE FOR
MYSELF TO GET A BEAD ON BETTER
SET OF TECHNOLOGIES OR BRAIN
EFFECTS THAT WE'RE TRYING TO
FOCUS ON AND WHETHER THERE'S
SOME KIND OF INTERESTING
COMMONALITY TO THE ETHICAL
QUESTIONS THAT MAKES IT
WORTHWHILE FOR US TO CONSIDER
THEM TOGETHER.
>>WINSTON, I WANT TO RESPOND.
INTENTIONALLY THESE ARE EXTREMES
THAT WE WANTED TO BRING TO THE
CONVERSATION.
WHICH IS TO LOOK AT WHAT IS, YOU
KNOW, THROUGH A CONSUMER
HEADSET, A VERY DIFFERENT KIND
OF EFFECT ON THE BRAIN,
IMMERSIVE EFFECT, HAS A
HEALTH-BASED APPLICATION VERSUS
INTERVENTIONAL EFFECT, WHETHER
OR NOT ETHICAL ISSUES ARE
DIFFERENT, THE SAME, WITHIN A
SPECTRUM, BUT REALLY TO TRY TO
MAKE THAT SCOPE MODULATING THE
BRAIN AND HOW WE MIGHT THINK
ABOUT IT FROM NEWG, WE MIGHT
WANT TO NARROW THE SCOPE IF WE
THINK ETHICAL ISSUES ARE QUITE
DIFFERENT ACROSS THE SPECTRUM OR
MIGHT THINK IT'S REALLY, YOU
KNOW, TECHNOLOGIES THAT IMPACT
THE BRAIN FROM A HEALTH-RELATED
PERSPECTIVE AND THINKING ABOUT
THAT IN THAT WAY.
BUT IT WAS INTENTIONAL TO MAKE
THE SCOPE LARGE IN THE NATURE OF
THE INTERVENTION TO STIMULATE
OUR THINKING ON THIS TOPIC.
>>I GUESS I'M STIM STRUGGLING A
LITTLE BIT WITH LIKE HOW TO DRAW
BOUNDARIES AROUND -- A LOT OF
THINGS INVOLVE TECHNOLOGY,
AFFECT THE BRAIN, I'M NOT SURE
SO LIKE TELEPSYCHOTHERAPY
AFFECTS THE BRAIN, OR ONLINE
EDUCATION IS A TECHNOLOGY THAT
AFFECTS THE BRAIN, SO I GUESS
HOW TO, YOU KNOW, GET MY ARMS
AROUND WHAT WE THINK IS IN SCOPE
AND WHAT'S NOT IN SCOPE.
>>I THINK IT DEPENDS ON WHAT IT
IS WE WANT TO DO WITH IT, RIGHT?
SO IF WHAT WE WANT TO DO IS A
WORKSHOP TO EXPLORE ISSUES MORE
BROADLY AND THEN TO DECIDE WHAT
A PRODUCT MAY BE, A BROADER
CONVERSATION MAY MAKE SENSE TO
NARROW IN SCOPE.
IF WE THINK IT'S SPECIFIC WE'RE
READY TO DIVE INTO THINKING
ABOUT WORKING ON A WHITE PAPER
OR GUIDANCE, THINKING ABOUT
THESE ISSUES WITHIN THE CONTEXT
OF GIVEN THE BREADTH, THE
EFFECT, WHAT IS THE NEXT STEP
FOR NEWG WITH RESPECT TO
TARGETED GUIDANCE OR TARGETED --
NOT GUIDANCE BUT TARGETED
CONTRIBUTIONS AND HOW MIGHT WE
DO THAT.
IT MAY BE WE NEED TO NARROW
THROUGH A WORK SHORTSTOP OR
ADDITIONAL CONVERSATIONS.
>>MAYBE I CAN ADD ONE THING
BEFORE I HAVE A WHOLE ARRAY OF
HANDS UP.
WE TALKED AT SOME POINT IN THE
PLANNING OF THIS DAY, WE TALKED
ABOUT THE QUESTION OF SHOULD
THERE BE I DON'T KNOW, LIMITS I
GUESS IS THE WORD I WOULD USE,
THAT'S PROBABLY NOT THE RIGHT
WORD, LIMITS ON INTERVENTIONS
THAT AFFECT THE BRAIN.
AND AS NITA POINTED OUT TO US
THEN, AND YOU SAID, WINSTON, THE
NUMBER OF THINGS THAT AFFECT THE
BRAIN IS HUGE.
SO THE QUESTION IS, IF THERE ARE
LIMITS ARE THERE LIMITS FOR
CERTAIN KINDS OF INTERVENTIONS
ONLY AND IF SO WHY?
AND/OR ARE THERE NO LIMITS?
HOW TO THINK ABOUT QUOTES --
THOSE KINDS OF QUESTIONS DROVE
US TO THINK ABOUT TODAY AS
PLANNED.
SO, JIM?
>>THANKS.
ONE ORB COMMENT.
SORRY, KAREN, MAYBE I JUMPED
AHEAD OF YOU.
SORRY ABOUT THAT.
ONE OF THE THINGS STRIKING,
THERE'S REALLY NOTHING THESE
GUYS CAN DO ABOUT IT, BUT I
WORRY ABOUT GOING TOO FAR DOWN
THE ROAD OF ETHICAL
CONSIDERATIONS WHEN THE POWER OF
A STUDY IS SO LOW.
SO I WONDER ABOUT WHETHER OR NOT
IN THINKING ABOUT THESE TYPES OF
NEURAL INTERVENTIONS WHETHER OR
NOT THERE'S SOME GUIDANCE WE CAN
GIVE ABOUT POWER OF THE STUDIES,
OR GETTING DATA.
IN MY FIELD IT CAN TAKE TWO
YEARS TO GET A PAPER PUBLISHED.
I DON'T KNOW ABOUT THIS FIELD
BUT I WONDER IF THERE'S GUIDANCE
GETTING DATA OUT MORE RAPIDLY SO
MORE DECISIONS OR INSIGHT CAN BE
PROVIDED WITH RESPECT TO THESE
TYPES OF CONSIDERATIONS.
>>INTERESTING POINT.
I'M GOING FROM LEFT TO RIGHT,
MAYBE THAT'S NOT THE RIGHT WAY.
IF I'M DOING IT RIGHT, TED ABEL
IS NEXT.
YOU'RE ON MUTE, TED.
>>LET KAREN GO.
SHE WAS -- I WAS GOING TO ASK
BASICALLY THE SAME QUESTION THAT
JIM ASKED, SEEMS LIKE WITH THE
NEUROSURGICAL STUDIES YOU COULD
ALMOST NEVER HAVE THE N, AND I'M
ON A WORKING GROUP OF THE
NATIONAL ADVISORY MENTAL HEALTH
COUNCIL THAT'S THINKING ABOUT
HIGH DIMENSIONAL DATASETS, AND
HOW TO HANDLE THEM.
YOU KNOW, WE'RE REMINISCING ON
Ns OF SIX SCIENCE PAPERS OF
GENETIC IMAGING STUDIES, YOU
KNOW, WHATEVER.
IT'S REALLY A CONCERN.
SO I REALLY WANT TO UNDERSCORE
THAT, WHAT JIM JUST SAID.
I THINK THE MECHANISM MIGHT HELP
YOU IF YOU HAVE A SENSE OF IT
BUT ONE OF THE THINGS YOU
OBVIOUSLY REALLY HAVE TO BE
CONCERNED ABOUT IS SELECTION
BIAS, IN TERMS OF THE PATIENTS,
NOT JUST WILLING TO DO THIS BUT
AT THAT LEVEL OF BEING --
NEEDING THE NEUROSURGERY AND
BEING DEPRESSED, SEEMS LIKE IT'S
HARD TO GENERALIZE SO I THINK
IT'S VERY CHALLENGING.
THE OTHER POINT I WANT TO MAKE,
QUESTION I WANT TO ASK, THERE
WAS THIS -- THERE IS THE
THINKING ABOUT THE BLACK BOX
WARNING ON ANTIDEPRESSANTS, AND
YOU WONDER, OBVIOUSLY THERE'S A
LOT OF CONTROVERSY ABOUT THAT,
WE JUST DID AN INTERESTING STUDY
GROUP HERE ON SO CALLED TWICE
EXCEPTIONAL INDIVIDUALS
DIAGNOSED WITH AUTISM WITH A
GIFTED I.Q., THEY HAVE INCREASED
SUICIDAL IDEATION AND THAT GOT A
LOT OF RESPONSES ON SOCIAL
MEDIA.
IT'S AN IMPORTANT ISSUE.
I WONDER HOW MUCH WE'RE THINKING
ABOUT THAT.
I WAS STRUCK BY THE
DESCRIPTION
OF THE PATIENT.
I'M NOT A HUMAN PSYCHIATRIST,
I'M A MOUSE PSYCHIATRIST, BUT
STRUCK BY THE DESCRIPTION OF THE
PATIENT ANDREW GAVE BECAUSE IT
SEEMED LIKE SOMEBODY WHO WOULD
BE SUFFICIENTLY NOT DEPRESSED TO
BE ACTIVATED TO MAYBE BE ABLE TO
COMMIT SUICIDE.
OBVIOUSLY CAN'T DO THAT BUT I
WONDER HOW WE HANDLE SIDE
EFFECTS OF THIS AND THERE'S AN
OBVIOUS ONE HERE WHICH IS THAT.
AND I DIDN'T REALLY HEAR THAT.
I HEARD EVERYONE FOLKING FOLKI-
FOCUSING ON IMPACT, HOW WOULD WE
THINK ABOUT THE SIDE EFFECT --
NOT SIDE EFFECTS BECAUSE I DON'T
KNOW THAT SUICIDE IDEATION IS
NECESSARILY A SIDE EFFECT.
>>IMPORTANT PART OF THE
PROBLEM.
DID WE LOSE KAREN?
THERE SHE IS.
KAREN, GO AHEAD.
>>SORRY, I HAVE A FUSSY PUPPY.
SO, I REALLY LIKED THE BREADTH
AND INVITATION FOR US TO THINK
ABOUT EVEN MORE FOUNDATIONAL
NEUROETHICS ISSUES WE DON'T DIVE
INTO BECAUSE I THINK THERE IS A
BIG PROBLEM ON THE HORIZON, OR
CHALLENGE AND INTENTION AROUND
MAKING KIND OF THE INVISIBLE --
SOMETHING THAT'S INVISIBLE TO
THE PATIENT OR PARTICIPANT
VISIBLE TO THEM.
AND WHETHER THAT REALLY
RESEMBLES THEIR TRUTH.
AND WHETHER THAT REALLY EMPOWERS
THEM.
SO, YOU KNOW, I THINK FOR THE
DBS EXAMPLE, DR. KRYSTAL SAID I
THINK WE'RE ADDRESSING A POINT
IN THE PROCESS BEFORE MAYBE A
PATIENT IS EVEN AWARE OF WHAT'S
HAPPENING TO THEM.
SO THAT'S A POSITIVE
INTERVENTION, RIGHT?
MAYBE YOU DON'T WANT A PATIENT
TO BECOME AWARE IF YOU'RE
DEPRESSED.
AND DR. PANDRANGI SAID -- HE WAS
TALKING ABOUT SOMETHING
INVISIBLE, SOMETHING ABOUT THE
SUBJECTIVE NATURE OF PAIN, WHICH
HAS ALWAYS BEEN A PROBLEM.
IT'S EVEN MORE PROBLEMATIC FOR
THE PATIENT.
SO, I THINK THAT AS WE -- AND
THE BRAIN BEHAVIOR
QUANTIFICATION AND
SYNCHRONIZATION EFFORT TRYING TO
QUANTIFY BEHAVIORAL COMPONENTS
FITS TOGETHER IN STILL
ADDRESSING THAT TENSION AND WHAT
HAPPENS IF WHAT WE RECORD OR
WHAT WE QUANTITATIVELY THINK
WE'RE ASSESS DIFFERS FROM THE
SUBJECTIVE EXPERIENCE IN THE
PARTICIPANT AND HOW DO WE MAKE
THAT RIGHT AND THE PARTICIPANT
IS EMPOWERED OR PATIENT IS
EMPOWERED, IT'S A HARD QUESTION
BUT SOMETHING THAT'S GOING TO BE
RELEVANT TO A LOT OF BIOMETRIC
TECHNOLOGY, EVEN MORE TRICKY
WITH BRAIN TECHNOLOGY.
AND I THINK AS FAR AS SCOPE, I
MEAN, WE'VE BEEN -- MAYBE FOR
GOOD REASONS, WE'VE BEEN PRETTY
TRADITIONAL HOW WE'VE SCOPED OUR
NEUROETHICS ISSUES, TRYING TO
PUSH BEYOND THAT AS WE THINK
DEEPLY ABOUT JUSTICE ISSUES,
D.E.I., AND HOW IT INTERSECTS.
I WAS PLEASED TO SEE HELENE
LANGEVIN ON THEIR TALKING ABOUT
PLACEBO, WHAT A BIG DEAL TO HAVE
NOT TALKED ABOUT YET BUT MAYBE
THIS OFFERS AN OPPORTUNITY TO
TALK ABOUT BRAIN MECHANISMS.
AND MAYBE WE COULD SCOPE IT AT
FIRST ON TECHNOLOGY THAT BRAIN
FUNDS, SO WE'RE NOT LOOKING AT
EVERYTHING BECAUSE PART OF OUR
APPROACH SHOULD BE USING THE
BRAIN INITIATIVE KIND OF AS A
PILOT AREA WHERE WE DISSEMINATE
TOOLS AND BEST PRACTICES THAT
OTHERS CAN USE.
>>GREAT POINTS.
THANK YOU, KAREN.
CAROLINE?
>>YEAH, THANK YOU, CHRISTINE.
I ALSO WANT TO THANK NITA AS
WELL FOR INVITING US TO OPEN
THIS CONVERSATION AND CONSIDER
WHAT NEWG COULD DO AND ENVISION
THAT FOR THE FUTURE.
I THINK THIS PROMPT WAS
INTERESTING TO ME BECAUSE IT
MADE ME THINK ABOUT THE
EVOLUTION OF THE BRAIN
INITIATIVE.
AND ITS START IN THE DEVELOPMENT
OF NEW TOOLS AND TECHNOLOGY TO
BETTER MAP AND STUDY THE BRAIN
AND THEN WITH THE SECOND PHASE
THE BRAIN INITIATIVE BUILDING ON
THE PROGRESS OF THAT FIRST
PHASE.
AND APPLYING THAT TOWARD
DISCOVERY-DRIVEN SCIENCE, IN
SOME CASES WE'RE ALREADY SEEING
NEAR-TERM HEALTH POTENTIAL
APPLICATIONS AS WE SAW TODAY
FROM THESE TWO TALKS.
AND WHILE I'M STILL NEW TO THE
NEWG, I HAD MY FIRST MEETING
LAST TIME, I THINK WHAT THIS
PROMPT HELPED ME THINK ABOUT IS
HOW THE NEWG COULD EVEN STAND
WHAT IT'S DONE IN THE PAST TO
THINKING ABOUT HEALTH
APPLICATIONS, IN TERMS OF SCOPE
PERHAPS THINKING ABOUT IT IN
TERMS OF SOME OF THE BREAD AND
BUTTER OF WHAT NIH AND "BRAIN"
HAVE CONTINUED TO FOCUS ON.
ONE DIMENSION TO THIS I THINK
THAT CAME TO MY MIND WAS
THINKING ABOUT THE SBIR PATH,
AND THINKING ABOUT AN SBIR PATH,
HAVING THE NEWG ENGAGE MORE
CLOSELY WITH APPLICATIONS AND
PROJECTS THAT ARE GOING THROUGH
THAT PIPELINE COULD BE A
UNIQUE -- I THINK THAT'S HOW YOU
PUT IT, NITA, A UNIQUE
APPLICATION TO LEVERAGE SKILL
SETS OF NEWG MEMBERS INCLUDING
YOURSELF, NITA, KAREN, MANY
OTHERS WHO HAVE BEEN INVOLVED IN
TRANSLATION OF NEUROTECHNOLOGIES
AS WELL AS ETHICAL COMPONENTS OF
IT.
ONE THE OTHER REASONS I THOUGHT
ABOUT THIS TOO IN THE CONTEXT OF
THOSE TWO TALKS IS BECAUSE IT'S
STILL SOMEWHAT AGNOSTIC TO
PARTICULAR TYPE OF BRAIN
INTERVENTION.
INSTEAD, THE DIE MENTION IS HOW
FAR ALONG ARE THESE TECHNOLOGIES
IN LET'S SAY POTENTIAL
COMMERCIALIZATION.
IT'S ALSO SOMEWHAT AGNOSTIC TO
THE LEVEL OF EXPLANATION OF
MECHANISM, AS JOHN HAD PUT, SO
FOR BETTER OR WORSE THAT PATHWAY
COULD BE BETTER OR NOT SO
EXPLAINED IN TERMS OF MECHANISM.
SO THAT WAS ONE MODEL I THINK
THAT I THOUGHT ABOUT THAT COULD
BE UNIQUE FOR THIS GROUP.
IT COULD, AS KAREN HAD TALKED
ABOUT EARLIER, BE A CHUNK THAT
COULD BE BITTEN OFF OF IN A MORE
MANAGEABLE STYLE, BUT I THINK WE
ALSO HAVE A LOT OF MODELS THAT
KIND OF ADVISING FROM VARIOUS
DOMAINS, WHETHER IT BE IEEE
BRAIN NEUROETHICS, THE SEE
KAREN'S LOGO BEHIND HER, PERHAPS
THAT COULD BE ONE AVENUE FOR A
NEW TYPE OF ENGAGEMENT.
THAT WAS ONE THOUGHT.
THE SECOND THOUGHT I HAD, AS I
WATCHED THESE TALKS, ALSO
REFLECTED ON NEWG MEETING, POST
TRIAL RESPONSIBILITIES WORKSHOP
BACK IN MAY, IS THAT IT SEEMS
LIKE THE INVITATION TO INCLUDE
PATIENT OR END USER PERSPECTIVE
IN THESE CONVERSATIONS WAS
REALLY STRONG.
I THINK THAT IT COULD BE A
STARTING POINT FOR EVEN DEEPER
ENGAGEMENT THROUGH LET'S SAY
FOLLOW-ON RESEARCH GRANTS OR
GRANTS THAT CAN FUND ENGAGEMENT
OPPORTUNITIES BETWEEN
RESEARCHERS AND PATIENTS.
SO THAT'S ANOTHER AVENUE JUST
BASED ON WHAT I'VE OBSERVED SO
FAR.
>>GREAT.
>>LET ME JUMP IN FOR JUST A
MOMENT TO SAY THANK YOU,
CAROLINE, FOR THOSE.
AND I THINK THINKING ABOUT EACH
OF THOSE ENGAGEMENTS IS PART OF
WHAT I'M HOPING WE'RE GOING TO
BE THINKING ABOUT, WHERE ARE WE
GOING, WHAT'S THE IMPACT WE WANT
TO HAVE.
I WANT TO CONNECT UP THE TWO
TALKS FOR A MOMENT AS FOLKS ARE
THINKING ABOUT IT.
A LOT OF THE EMERGING VR
HEADSETS ALSO HAVE INTEGRATED
SENSORS FOR EEG TO PICK UP BRAIN
WAVE ACTIVITY, AT LEAST TO A
LIMITED EXTENT.
AS WE THINK ABOUT CLOSED LOOP
VERSUS OPEN LOOP, JUST TO PUT AN
ETHICAL PIECE ON THE TABLE FOR
US TO THINK ABOUT, SOME OF IT IS
ABOUT CLOSED LOOP EVEN WITHIN
VR, RIGHT?
THAT ISN'T LIMITED JUST AT ONE
END OF THE SPECTRUM OR THE
OTHER.
AS WE THINK ABOUT WHAT WE MIGHT
DO AND DIMENSIONS AND ETHICAL
PIECES AND ENGAGING WITH OTHERS,
IT'S NOT REALLY THAT THESE ARE
TWO ENDS OF THE SPECTRUM.
THEY ARE INTEGRATED IN A LOT OF
ETHICAL ISSUES WE MIGHT CONFRONT
AND THINK ABOUT AND HOW WE MIGHT
THINK ABOUT ENGAGING OTHER
EFFORTS THAT ARE UNDERWAY FOR
TRANSLATIONAL IMPACT AS CAROLINE
POINTS TO.
>>GREAT.
BE .
>>ANDREA DID WE LOSE YOU'RE
HAND?
>>YOU'RE NICELY BROUGHT IT BACK
TO BRAIN AND IN TERMS OF
RESEARCH SO WE DO GET AWAY FROM
SOME OF THE THINGS THAT ARE
STILL VERY INTERESTING BUT
WINSTON RAISED THE SCOPE ISSUE.
BUT I FEEL LIKE YOU'VE ALREADY
GOTTEN THERE WITHOUT MY HELP.
>>OKAY.
WITH YOUR HELP THOUGH.
JIM?
>>THANKS.
I PROMISE THIS WILL BE MY LAST
COMMENT.
I WANTED TO FOLLOW UP ON WHAT
SOME OTHER HAD SAID, IN
PARTICULAR, CAROLINE.
JUST AS REMINDER, THE
NEUROETHICS ROAD MAP HAD
SUGGESTIONS AND COMMENTS WITH
RESPECT TO THESE VARIOUS ISSUES,
AND SO DRAWING ATTENTION TO IT
AND HOW NEWG OR OTHER ENTITIES
MIGHT BE INVOLVED IN HELPING TO
ADDRESS SOME OF THESE,
RECOGNIZING THESE ISSUES AND
HELPING ADDRESS THEM BUT I
ACTUALLY THOUGHT CAROLYN'S
SUGGESTION ABOUT THE SBIR
MECHANISM IS REALLY INTRIGUING.
I DON'T KNOW THAT BRAIN DOES
SBIRs, BUT TO ENGAGE COMPANIES
EARLY ON WHEN THEY ARE JUST
STARTING OUT WITH ETHICAL
GUIDANCE, IF YOU WILL, OR AT
LEAST AN OPPORTUNITY TO INTERACT
ON ETHICAL ISSUES, IT'S A REALLY
GOOD IDEA, IT'S SOMETHING THAT
NEWG COULD BE INVOLVED WITH.
AND MIGHT HAVE AN IMPACT VERY ON
IN DEVELOPMENT OF THESE
TECHNOLOGIES.
>>GO AHEAD, JOHN.
>>WE DO INDEED FUND SBIRs.
WE'RE MANDATED BUT WE ACTUALLY
DO SELECT OUT ONES THAT FIT OUR
SPACE.
I THINK WE SHOULD LOOK INTO.
THERE'S CERTAINLY ONES THAT
WOULD BENEFIT AS TO MANY OF OUR
OTHER FUNDED STUDIES, FOR THEIR
CONSIDERATION, WE MIGHT EXPAND
OUR THINKING WHAT MIGHT BE
APPROPRIATE AND RELEVANT.
THAT'S A GREAT POINT.
THANK YOU.
>>WE DO HAVE MEMBERS OF THAT
TEAM ON THIS CALL SO I'M SURE
THEY HEARD THE COMMENT AS WELL.
>>RIGHT.
>>JIM, I WOULD ENCOURAGE YOU TO
HIGHLIGHT SOME OF -- KAREN PUT
THE REPORT BACK UP BUT SOME WAYS
NEWG COULD ENGAGE ON THESE
ISSUES PULLING THEM OUT OF THE
REPORT INTO THE CHAT FOR US TO
BRING BACK AS A THREAD THROUGH
THE CONVERSATION WOULD BE
TERRIFIC.
INCLUDING OBVIOUSLY THE SBIRs
THAT YOU HIGHLIGHTED.
>>THANKS.
>>SYD?
>>YEAH, THIS IS A FOLLOW-UP ON
JOHN'S COMMENT ABOUT MECHANISM
BUT ONE OF THE KIND OF STRIKING
DIFFERENCES FOR ME BETWEEN THESE
TWO STUDIES THAT WE HEARD ABOUT
IS THE FIRST ONE, DBS FOR
DEPRESSION, IS VERY HYPOTHESIS
DRIVEN.
THEY HAVE, YOU KNOW, TARGET
AREAS OF THE BRAIN WHICH HAVE
BEEN STUDIED, WHICH THEY ARE
GOING TO TRY TO INTERVENE ON,
WHEREAS THE VR STUDY STRUCK ME
AS BEING A LITTLE UNDERBAKED.
THEY DIDN'T SEEM TO HAVE AN IDEA
OF HOW THIS MIGHT WORK OTHER
THAN, YOU KNOW, IT'S MORE
DISTRACTING OR SOMETHING, THAN A
2D ENVIRONMENT MIGHT BE.
AND SO, YOU KNOW, REALLY NOT
HIGH
HYPOTHESIS DRIVEN, I TRIED TO
PUSH ON WHAT QUESTION, WHAT IS
YOUR HIGH -- HYPOTHESIS, COOL,
THEY WORK, BUT NOT UNDERSTANDING
HOW OR WHY THEY WORK, YOU KNOW,
OBVIOUSLY THE BRAIN IS INVOLVED
WHEN WE'RE TALKING ABOUT PAIN
BOTH IN TERMS OF THE SUBJECTIVE
EXPERIENCE BUT THERE ARE ALSO,
YOU KNOW, OBJECTIVE MEASURES OF
PAIN, RIGHT?
SOMEONE'S HEART RATE AND HOW
FAST THEY ARE BREATHING AND ALSO
OBVIOUSLY THINGS GOING ON IN THE
BRAIN SO THERE'S ALL KINDS OF
BIOMARKERS OR BIOFEEDBACK THEY
MIGHT BE STUDYING TO HAVE A
HYPOTHESIS ABOUT WHAT'S GOING ON
WHEN THEY ARE USING THAT.
SO, I DON'T KNOW TO WHAT EXTENT
WE WANT TO GET INTO THAT ISSUE
OF SHOULD OUR RESEARCH BE
HYPOTHESIS DRIVEN THIS WAY OR,
YOU KNOW, IS THIS JUST KIND OF
AN INTERESTING THING AND MAYBE
WE WANT TO SEE WHAT HAPPENS.
I WOULD LIKE TO SEE RESEARCHERS
WHO ARE THINKING MORE CAREFULLY
AND DEEPLY ABOUT WHY SOMETHING
MIGHT WORK AND WHY IT IS
WORKING.
WITH THE VR ONE REASON IS
BECAUSE I THINK THERE IS
POTENTIAL FOR ABUSE WITH A
COMMERCIALLY AVAILABLE PRODUCT
THAT PEOPLE MIGHT JUST SAY, HEY,
I FEEL BETTER WITH THIS, I'M
GOING TO KEEP DOING IT.
>>GOOD POINT.
SAMEER?
>>YEAH, I WANT TO PICK UP A
COUPLE THREADS, NITA, CAROLINE,
A COUPLE OTHERS, AND MAYBE KIND
OF PUT UNDER CATEGORY OF THIS
CONFLICT BETWEEN
INDIVIDUALIZATION VERSUS
GENERALIZABILITY.
SO, WE TALKED ABOUT THE WORKSHOP
BACK IN MAY, IT WAS AMAZING.
UNANIMOUSLY EVERYONE ENJOYED
HEARING FROM THE RESEARCH
SUBJECT PATIENT INDIVIDUAL AND
HEARING THEIR THOUGHTS ABOUT WHY
THEY PARTICIPATED, WHAT THEY GOT
OUT OF IT, ET CETERA, SOMEONE
COMMENTED HERE ABOUT ANDREW'S
PRESENTATION.
YOU KNOW, UNDERSTANDING THE
HUMAN -- YOU TALKED ABOUT THIS
IN THE MOUSE PSYCHIATRY THING
ABOUT, YOU KNOW, KNOWING WHAT IT
IS FROM THEIR PERSPECTIVE, WHAT
THEY FELT LIKE, WHAT THEY WENT
THROUGH.
SO, THIS IS OVER A HUMAN NATURAL
IDENTIFIABLE POIGNANT, I THINK
THE CONFLICT THERE IS PERHAPS
WITH HOW FAR DOWN THIS
INDIVIDUALIZATION RABBIT HOLE DO
WE GO VERSUS IDENTIFYING
THERAPIES THAT ARE
GENERALIZABLE, BECAUSE IF YOU GO
DOWN REALLY FAR THEN YOU'RE IN
THE SITUATION WHERE YOU HAVE TO
DO THIS VERY -- TO TAKE ANDREA'S
EXAMPLE, THIS COMPLEX IMPLANT, A
LOT OF TIME, MONEY, EFFORTS, ET
CETERA, PERHAPS EVERY SINGLE
PATIENT WHICH IS JUST NOT
FEASIBLE.
I WANTED TO ASK THE QUESTION.
WE HAVE A STUDY IN SOME WAYS
SIMILAR BUT IN THAT WAY VERY
DIFFERENT.
IT WOULD BE FUN TO TALK ABOUT
THAT.
I THINK THIS GETS INTO THE
NEUROETHICS SPACE BECAUSE IT'S A
MATTER OF ACCESS AND USE OF
RESOURCES.
SO HOW MANY -- HOW MUCH CAN WE
INVEST IN BEING SO
HYPERINDIVIDUAL THAT EVERYONE IS
SUPER DIFFERENT AND WE HAVE TO
DO SOMETHING THAT'S EXPENSIVE OR
TIME CONSUMING OR EFFORT
CONSUMING, YOU KNOW, FOR EVERY
PERSON BECAUSE WE KNOW THERE'S
GOING TO BE SLIGHT DIFFERENCES
VERSUS HOW MUCH DO WE SAY, LOOK,
WE HAVE TO FIND THINGS THAT ARE
GENERALIZABLE AND IT'S OKAY THAT
MAYBE NOT EVERY SINGLE ONE IS AN
ABSOLUTE, LIKE BOTTOM OF THE
9th GRAND SLAM BUT THERE'S
MANY THAT ARE SOLID TWO-BASE
HITS THAT STILL WIN THE GAME.
THIS I THINK CUTS THROUGH A
COUPLE DIFFERENT -- MANY OF THE
ISSUES WE TALKED ABOUT.
IT'S NOT SPECIFIC TO INVASIVE OR
NON-INVASIVE OR HUMAN OR ANIMAL,
WHATEVER.
THIS MAY SOMETHING THAT WE COULD
IDENTIFY AS MAYBE A
CROSS-CUTTING THEME THAT IS
WORTH THINKING ABOUT AT VARIOUS
DIFFERENT LEVELS.
>>DO YOU SEE WALTER'S QUESTION
FOR YOU IN THE CHAT, SAMEER?
>>THANKS, WALTER.
HOW IS THIS DIFFERENT THAN WHAT
OCCURS IN EPILEPSY?
IT'S NOT.
IT'S JUST HARDER TO FIND
DEPRESSION BECAUSE WE DON'T KNOW
WHAT WE'RE LOOKING FOR.
IT'S NOT.
THIS IS WHERE IT'S BORROWED
FROM.
WE DO THIS IN EPILEPSY, BUT DO
WE REALLY?
HOW MANY PEOPLE CAN ACTUALLY
HAVE THAT DEGREE OF ACCESS AND
SO WE DO IT THEORETICALLY AND A
LOT OF CENTERS OF COURSE DO IT
PRACTICALLY.
BUT NOW ARE ARE GOING TO DO THAT
FOR EVERY BRAIN-BASED DISORDER,
EVERY NERVOUS SYSTEM-BASED
DISORBED?
DISORDER?
WHAT CAN WE DO THAT IT'S GOING
TO BENEFIT MANY MORE PEOPLE,
MAYBE NOT TO THE Nth DEGREE
BUT ENOUGH TO GET THEM BETTER,
FUNCTIONAL.
>>GREAT POINTS.
WE TALKED ABOUT THIS AS WELL.
ON THE ONE HAND VARIABILITY
SEEMS TO BE VEXING, OBSTACLE.
ON THE OTHER HAND VARIABILITY
ONCE YOU FOLKS HAVE ENOUGH
PATIENTS THAT YOU'VE WORKED
WITH, YOU MIGHT UNDERSTAND
BETTER THE SOURCES AND
VARIABILITY, AT LEAST WHAT THEY
MEAN IN TERMS OF PATIENT'S
CONDITION AND RESPONSE TO
DIFFERENT THERAPIES.
I MEAN, NOT TO BE TOTAL
POLLYANNA BUT I THINK THESE ARE
STILL EARLY DAYS.
WE HAVE A LOT YET TO LEARN.
I SEE IN ALL AREAS OF BIOLOGY
THERE'S THE INITIAL KIND OF
REACTION TO RUN, BUT IF YOU
EMBRACE IT, IT CAN TEACH US
SOMETHING, SOMETHING TO KEEP OUR
MINDS ON.
THE OTHER THING, IF WE ARE TRULY
AS A FIELD TO DEMOCRATIZE THESE
KINDS OF TECHNOLOGIES FOR THESE
DISORDERS, YOU WON'T BE ABLE TO
IMPLANT THEM AND STUDY THEM FOR
TEN DAYS, IT'S JUST NOT GOING TO
BE I DON'T THINK FEASIBLE.
BUT TO THE EXTENT THAT YOU CAN
GENERATE GOOD DATA, UNDERSTAND
THE VARIABILITY, MAYBE ONE DAY
USING NON-INVASIVE RECORDING
METHODS MIGHT GET YOU CLOSE
ENOUGH TO HELP PEOPLE OUT.
THESE ARE ISSUES WE WANT TO KEEP
OUR EYES ON BUT THE EXPECTATION
IS THE TECHNOLOGY AND OUR
UNDERSTANDING IS NOT GOING TO BE
STATIC, RIGHT?
IF WE ASSUME THAT, WE WOULDN'T
BE DOING THIS.
IT'S IMPORTANT TO KEEP OUR EYES
KIND OF ON THAT LONGER TERM
GOAL, AND WITH THE -- REALLY
WITH THE EXPECTATION IT'S GOING
TO GET BETTER ENOUGH TO DO THIS
IN A DIFFERENT WAY MORE SCALABLE
BECAUSE ULTIMATELY WE DO NEED TO
SCALE THIS.
>>RIGHT.
THAT'S ONE ANSWER, MAYBE ONE OF
THE BETTER OR BEST ANSWERS.
YOU KNOW, LIKE, RIGHT, WE HAVE
TO DO DISCOVERY, UNDERSTAND WHAT
OF THE VARIABILITY, WHAT ARE THE
FIRST COUPLE PRINCIPLE
COMPONENTS OF IT, AND WE HAVE TO
HAVE SOME SENSE OF BREADTH
BEFORE WE CAN IDENTIFY WHAT
THOSE ARE SO MAYBE ONE POTENTIAL
ANSWER TO THE QUESTION IS WE
NEED TO THINK OF, VISUALIZE SOME
PATHWAY TOWARDS HOW THIS IS
GOING TO HELP WITH EVENTUAL
GENERALIZATION BECAUSE OF
UNPROVEN TECHNOLOGY THAT MAKES
IT COSTLY, WHATEVER, BUT THAT
KEEPS US ON TRACK SO WE DON'T
GET SO OFF THE TRAIL THAT WE'RE
LIKE REALLY FOCUSING ON ONE
INDIVIDUAL IN THE WORLD AT THE
EXPENSE OF MANY, MANY OTHERS.
>>GREAT POINT.
NITA?
>>YES, SO THIS IS A RICH AND
REALLY GREAT STARTING POINT I
THINK TO THE CONVERSATION.
FOCUSING ON WHAT IF ANYTHING
NEWG MIGHT DO IN THIS SPACE THAT
COULD BE SPECIFIC, CONCRETE,
IMPACTFUL.
I THINK THE QUESTION IS WHERE
AND HOW WE MIGHT WANT TO ENGAGE,
AND JIM MENTIONED THAT THE
REPORT TALKED THROUGH SOME OF
THE OPPORTUNITIES FOR
ENGAGEMENT, AND I WONDER IF I
MIGHT PUT HIM ON THE SPOT AND
INVITE HIM TO PUT SOME OF THOSE
ON THE TABLE FOR US TO DISCUSS
AS A STARTING PLACE RATHER THAN
REINVENTING THE WHEEL.
BUT THE QUESTION I THINK AT HAND
IS, YOU KNOW, FIRST SHOULD WE,
AND I THINK THE ANSWER TO SHOULD
WE, IF WE CAN DO SOMETHING
CONCRETE, SPECIFIC, IMPACTFUL,
COULD BE WE NEED FURTHER
CONVERSATIONS, WE'RE READY TO
DIVE INTO A PAPER OR SPECIFIC
KINDS OF RECOMMENDATIONS ACROSS
A PARTICULAR SPACE, BUT
SOMETHING THAT COULD BE USEFUL
IS MY HOPE WE'LL FOCUS OUR
EFFORTS ON.
JIM, COULD I ASK YOU TO PUT YOU
ON THE SPOT TO SAY PUT SOME OF
THOSE ON THE TABLE SO WE DON'T
REINVENT THE WHEEL OF THE
IMPORTANT WORK YOU'VE ALREADY
DONE ON THIS?
>>YOU CAN CERTAINLY ASK BUT
UNFORTUNATELY I HAVEN'T LOOKED
AT THE REPORT IN A WHILE.
WHAT I HAVE TO DO IS LOOK
THROUGH AND SEND PEOPLE AN
E-MAIL WITH, TO WHAT
RECOMMENDATIONS WERE UNLESS
KAREN OR CHRISTINE, ALSO ON THE
COMMITTEE, MIGHT REMEMBER MORE
SELECTIVELY.
WE DID HIGHLIGHT VARIOUS ISSUES
THAT MAY COME UP AND MIGHT BE
ADDRESSABLE, AND THERE WERE SOME
RECOMMENDATIONS ALONG THE WAY
BUT UNFORTUNATELY WHAT I HAVE TO
DO IS SEND AN E-MAIL FOLLOW-UP
WITH RESPECT TO IT.
SORRY, NITA.
>>THAT'S OKAY.
LET ME OPEN THE CONVERSATION
THEN --
>>I CAN ADD A FEW RELATED TO
THAT IF YOU'D LIKE.
>>PLEASE, KAREN.
>>I THINK ACTUALLY FOR FUTURE
REFERENCE, CHAPTERS 5 AND 6 ARE
PARTICULARLY HELPFUL, AND AT THE
END OF ALL OF THEM WE HAD A
GREAT STRUCTURE, THERE'S
BULLETED POINTS IN THE END,
ACTION ITEMS.
A LOT OF THEM I THINK HAVE
SPECIFIC THINGS BUT FIT AROUND
GENERAL THEMES THAT WITHIN WHAT
MOST OF US THINK NEWG SHOULD BE
DOING, AND A LOT OF THAT PROCESS
AND METHODOLOGY IS RAISING
AWARENESS, AND SOME OF THAT WILL
BE A DEVELOPMENT OF CERTAIN
RESOURCES, TOOLS, WE TALKED
ABOUT THAT FOR A LONG TIME BUT
NEUROETHICS ROADMAP DEMOCRATIZES
THAT.
THE OTHER IS ABOUT CONVENING,
SOMETHING WE'VE DONE WELL, AND I
THINK ALSO CAROLINE MENTIONED
SOMETHING IMPORTANT THAT I HOPE
COMES BACK TOO, WHICH IS
INVITATION TO INCLUDE ADVOCATES,
AND CHAPTER 5 ESPECIALLY TALKS
ABOUT REAL WORLD TRANSLATION SO
I THINK THERE'S PIECES IN THERE
THAT TALK ABOUT BUILDING
COMMUNITY THAT RAISE AWARENESS,
BUILDING TOOLS, THAT WE COULD
SPEAK TOWARDS.
TOOLS COULD BE CERTAINLY BREAD
AND BUTTER OF THIS ECOSYSTEM,
HIGH IMPACT ACADEMIC PAPER, BUT
THERE MIGHT BE SOME OTHER THINGS
THAT WE CO-CREATE TOO.
GENERALLY THOSE ARE THINGS I
WOULD ENCOURAGE US TO LOOK AT
THOSE SPECIFIC BULLETED POINTS
AND CALL OUT BOXES AROUND THOSE
THEMATIC AREAS.
I'LL LEAVE IT AT THAT.
>>YOU MAY REMEMBER WE HAD A
LIST OF THINGS THAT CAME OUT OF
THE ROADMAP THAT WERE POSSIBLE
TOPICS FOR THE NEWG TO WORK ON.
AND I HAVE THAT LIST, I THINK.
I DON'T KNOW IF IT'S THE MOST
UP-TO-DATE ONE BUT I COULD PULL
IT UP.
IT'S GOT A LOT OF STUFF ON IT.
AS KAREN SAID, SOME OF IT IS
SPECIFIC CHAPTERS BUT THERE'S
IDEAS THROUGHOUT THE ROADMAP FOR
DIFFERENT THINGS THAT MIGHT BE
RELEVANT TO WHAT WE'RE TALKING
ABOUT TODAY.
>>IT WOULD BE GREAT TO FOLLOW
THAT UP, CHRISTINE.
WHILE YOU DO THAT, I MIGHT
INVITE US TO THINK ABOUT
WHATEVER WE LAND ON IN THIS
SPACE THAT WINSTON SAID HE WAS
TRYING TO WRAP HIS HEAD AROUND
WHAT THE SCOPE OF THE
CONVERSATION REALLY IS ABOUT.
AND I WANT TO INVITE REFLECTIONS
ON THAT, THE CONVERSATION ON
PERSUADING, MODULATING,
MANIPULATING, CHANGING THE BRAIN
WHICH, AGAIN, COULD BE AN
ENORMOUS SCOPE.
ANDREA'S POINT IT'S FOCUSED ON
HEALTH AND BRAIN IS A LIMITING
FACTOR BUT NOT PRECISELY
LIMITING FACTOR SO I WANT TO
INVITE ANY COMMENTS ON INTEREST
IN SCOPING THE PROBLEM FOR
CONSIDERATION BY NEWG.
>>JOHN, YOU HAD A HAND THAT
WENT UP FOR A MILLISECOND?
NO?
IT WAS MY EYES PLAYING TRICKS ON
ME.
JIM?
>>YEAH, THANKS, NITA.
YEAH, WITH RESPECT TO THE SCOPE,
AGAIN MAYBE GOING BACK TO WHAT I
MENTIONED AT THE VERY BEGINNING
OF THIS DISCUSSION, FOR ME
REALLY ONE OF THE MOST IMPORTANT
ASPECTS IS REVERSIBLE VERSUS
NON-REVERSIBLE.
REVERSIBLE COULD BE PROBLEMATIC
BUT SOMETHING THAT'S NOT
REVERSIBLE MAYBE THERAPEUTIC FOR
A WHILE BUT THE TRIAL STOPS AND
THERE'S NO RECOURSE FOR THE
PATIENT AFTER THAT, I THINK THEY
DO REQUIRE DIFFERENT ETHICAL
CONSIDERATIONS AND WE MAY WANT
TO LIMIT OURSELVES TO ONE VERSUS
THE OTHER, MAYBE DISCUSS
DISTINCTIONS MORE BUT I THINK
THAT'S ONE OF THE KEY ASPECTS
FOR ME.
>>THAT'S HELPFUL.
I WILL SAY ONE IS A CATEGORY IS
IMPACT, RIGHT?
AS JIM HAS PUT WITHIN THAT
IMPACT WHETHER IT'S REVERSIBLE
OR IRREVERSIBLE.
TO ME PART OF THE QUESTION IS
HOW IT'S DONE AS WELL SO THAT'S
WHY I RAISE THE OPEN LOOP VERSUS
CLOSED LOOP, BECAUSE I THINK
THAT HAS INTERESTING DIFFERENCES
AND IMPLICATIONS PARTICULARLY AS
YOU BRING MORE A.I. INTO THE
PICTURE OF CLOSED LOOP FOR WHAT
MEANS AND HOW WE MONITOR AND
EFFECTS AND POSSIBLE RISKS AS
WELL.
WINSTON?
>>IF I COULD JUMP IN TO FOLLOW
UP ON JIM'S COMMENT.
THAT'S AN IMPORTANT POINT BUT
JUST TO MAKE IT A LITTLE BIT
MORE INTERESTING I MEAN HOW WILL
WE NECESSARILY KNOW AHEAD OF
TIME WHAT WILL BE REVERSIBLE OR
NOT REVERSIBLE?
>>AND WHAT DOES THAT EVEN MEAN,
RIGHT?
>>I WAS GOING TO PIVOT OFF OF
THAT ALSO.
I THINK THAT, YOU KNOW, IT'S
MAYBE IMPORTANT TO THINK ABOUT
BUT THERE'S A CONTEXT OF OTHER
THINGS THAT PEOPLE ARE DOING TO
AFFECT BRAIN FUNCTION, AS WE
SAID BEFORE, PROBABLY WOULDN'T
FULL UNDER THE SCOPE OF THIS
TECHNOLOGY BUT HAVE WIDE RANGING
IMPACTS WE DON'T UNDERSTAND.
YOU KNOW, THE NOVEL TECHNOLOGIES
ARE IN A SPACE WHERE THOSE OTHER
THINGS THAT ARE GOING ON WHERE
WE REALLY DON'T KNOW, I THINK
THAT, YOU KNOW, FOR ALL WE SAID
ABOUT MECHANISM OF ACTION LIKE A
LOT OF MEDICATIONS WIDELY USED
IN THE BRAIN WE DON'T REALLY
UNDERSTAND MECHANISM OF ACTION
AND STATISTICS IS 1 IN 8
AMERICANS IS TAKING AN SSRI, WE
DON'T REALLY KNOW HOW THEY WORK,
THERE'S A LOT OF CONTROVERSY
ABOUT WHAT THE LONG-TERM EFFECTS
OF THESE MEDICATIONS ARE AND SO
FORTH.
OF COURSE, THE CLINICAL TRIALS
ON WHICH THEY WERE APPROVED
FOLLOWED PEOPLE FOR MUCH SHORTER
PERIODS OF TIME AND WITH A
DIFFERENT MODEL FOR
PSYCHOPHARMACOLOGIC TREATMENT
THAN IS CURRENTLY BEING USED.
THERE'S SIMILAR QUESTIONS THAT
MIGHT -- THAT WE MIGHT HAVE
ABOUT OTHER WIDESPREAD
INTERVENTIONS, THINGS LIKE
UNIVERSAL CHILDHOOD EDUCATION IS
ONE THING WITH THE MOST
INFLUENCE ON BRAIN FUNCTION, WE
SEE IT IN MY FIELD OF DEMENTIA,
WHY AGE ADJUST THE RATES ARE
FOLLOWING IN MANY PLACES,
PROBABLY HAS TO DO WITH THINGS
LIKE THAT AS WELL AS OTHER SORT
OF HEALTH BEHAVIORS.
SO, I THINK THIS ISSUE OF
DISENTANGLING LONG-TERM EFFECT
IT'S OF BRAIN INTERVENTIONS FROM
ALL KINDS OF OTHER DOWNSTREAM
EFFECTS OF LIFESTYLE CHANGES OR
CHANGES IN THE KINDS OF LINES
OPENED UP TO PEOPLE, I THINK
GETS US INTO SOME OF THE REAL
MESSINESS ABOUT TRYING TO STUDY
THE BRAIN IN THE FIRST PLACE.
>>I THINK THAT'S RIGHT.
JOHN?
>>YEAH, THANKS, WINSTON.
IN TERMS OF WHAT WOULD HELP
"BRAIN," FROM OUR POINT OF VIEW,
REALLY THIS IS I THINK NEWG'S
ROLE AND THE VALUE TO "BRAIN" IS
LET ME TRY TO SYNTHESIZE A
COUPLE POINTS RAISED.
THERE'S AN ISSUE THAT CAME UP
ABOUT HAVING MECHANISM OR EVEN
ABSENT MECHANISM AT LEAST HAVING
A HYPOTHESIS FOR WHAT MIGHT BE
GOING ON, WHETHER YOU'RE GIVING
A PATIENT, YOU KNOW, A PILL OR
IMMERSIVE EXPERIENCE OR DIRECTLY
STIMULATING THE BRAIN WITH AN
IMPLANT OR INDIRECTLY SAY
THROUGH FOCUSED ULTRASOUND,
WHATEVER THE CASE, TO THE EXTENT
THAT WE UNDERSTAND MECHANISM
WOULD HELP US TRY TO NAVIGATE
THESE ISSUES, I THINK IT'S SAFE
TO SAY THAT THE BRAIN INITIATIVE
IS A NEUROSCIENCE INITIATIVE,
NEUROTECHNOLOGY INITIATIVE, NOT
A BRAIN SCIENCE.
WHEN WE'RE ULTIMATELY WORKING
WITH THE BRAIN IT'S BIOLOGICAL
ORGAN, BIOLOGICAL SYSTEM.
SO TO THE EXTENT WE MIGHT
CONSIDER HOW TO NOT SO MUCH
LIMIT BUT CONSTRAIN AT LEAST THE
INITIAL SET OF ARGUMENTS OR
QUESTIONS IN ORDER TO GET SOME
TRACTION I THINK IF WE STAY
WITHIN THE SPACE OF LOOKING AT
STUDIES OR FIELDS WHERE WE MAY
NOT UNDERSTAND -- WE STILL DON'T
UNDERSTAND FULLY THE MECHANISM
OF HOW THE BRAIN WORKS AND
THAT'S WHY WE'RE HERE, FOR MANY
GENERATIONS TO COME, BUT IF WE
CAN KEEP THE CONVERSATION IN THE
REALM OF WHAT'S BIOLOGICALLY
POSSIBLE AND WHAT'S
EXPERIMENTALLY TESTABLE, I THINK
THAT MIGHT KIND OF KEEP THE
CONVERSATION A LITTLE BIT MORE
REAL AND FROM, YOU KNOW, GETTING
TOO DIFFUSE BECAUSE ULTIMATELY
FROM -- I HATE TO BE
TRANSACTIONAL FROM THE BRAIN
STANDPOINT WE NEED TO UNDERSTAND
THE IMPACT OF WHAT WE'RE
SUPPORTING IN THESE DIFFERENT
AREAS THAT AFFECT HUMANS.
AND IT'S HARD FOR ME TO KIND OF
UNDERSTAND HOW WE'RE GOING DO
THAT IF WE'RE NOT THINKING ABOUT
A TESTABLE HYPOTHESES OR REALITY
OF MECHANISMS SO THAT'S MY
THOUGHTS FROM HEARING A LOT OF
YOUR INPUT HERE TODAY BASED ON
THE PRESENTATIONS AND
CONVERSATION HERE.
>>THANKS, JOHN.
TED?
>>YEAH, JOHN, TO EXTEND THAT
MORE, I'M THINKING BACK TO SOME
DISCUSSIONS WE HAD THINKING
ABOUT BRAIN-COMPUTER INTERFACE,
AND THE NEUROETHICS AROUND THAT,
THAT THAT SEEMS LIKE A MORE
CONCRETE DISCUSSION IN SOME WAYS
BECAUSE WHAT I WAS GOING TO SAY
IS WE'RE ACTUALLY ASSUMING -- I
MEAN ALL THESE THINGS AFFECT THE
BRAIN, DEPRESSION AND ET CETERA,
BUT WHAT THEY ARE AND THE NATURE
AS A DISORDER AND WHETHER THEY
ARE MICROBIOME OR OUR MOTHER'S
PLACENTA OR OUR ADRENAL OR OTHER
THINGS THAT ARE NOT NECESSARILY
MAPPED TO THE PREFRONTAL CORTEX
OR SOMETHING IS SOMETHING THAT
YOU KIND OF GET INTO WHEN YOU
THINK ABOUT THESE AS DISEASE
ENTITIES.
WHICH IS NOT WHAT WE'RE DOING,
RIGHT?
SO THAT'S I THINK WHAT YOU SAID,
JOHN, IS AN IMPORTANT AND ANDREA
CHIMED IN TO KEEP US THINKING
ABOUT THE BRAIN INITIATIVE.
THAT MAY MEAN THERE ARE
PARTICULAR ASPECTS IN THIS SPACE
WE MIGHT WANT TO FOCUS ON, AND
THE NEUROETHICS ISSUES OF THAT,
FOR EXAMPLE, THE BRAIN-COMPUTER
INTERFACE WORK.
>>PERFECT.
KAREN?
>>AGAIN, I REALLY LIKED THESE
THREE QUESTIONS.
I REALLY APPRECIATE THIS
APPROACH.
I THINK I WANT TO RESONATE WITH
OTHERS THE APPROPRIATE SCOPE
SEEMS TO BE WHATEVER "BRAIN" IS
DOING AND FUNDING, AND WHAT I
APPRECIATED CHRISTINE DID AT ONE
POINT, HANK ALSO DID AT EACH
MEETING, ASK THE RESEARCHERS WHO
WE INVITED TO ATTEND WHAT THEY
NEED AND WHAT WE CAN DO TO HELP
THEM.
AND I THINK KIND OF MY VISION,
MY PERSONAL VISION STATEMENT FOR
THIS GROUP HAS ALWAYS BEEN THAT
WE'RE EMPOWERING THE RESEARCHERS
SO THEY CAN EMPOWER THE PUBLIC
TO RECEIVE THE BENEFITS OF THEIR
SCIENCE.
THAT'S AN ORIENTATION, HOW CAN
WE HELP THE BRAIN RESEARCHERS?
AN OPEN QUESTION WHICH DOESN'T
FOCUS HERE LIKE FOR SCOPE BUT
STILL WHETHER WE WANT TO SERVE
IN A FORESIGHT FUNCTION OR EVEN
A FOUNDATIONAL ISSUE, KIND OF
ADDRESSING ISSUES LIKE WHAT IT
MEANS TO QUANTIFY THE HUMAN
EXPERIENCE.
MAYBE THIS IS DISTINCTION THAT
"BRAIN" HAS ON PURPOSE FROM THE
HUMAN BRAIN PROJECT BUT THE
HUMAN BRAIN PROJECT PUT OUT A
LOT OF MATERIALS ON THOSE TYPES
OF ISSUES THAT REALLY INTERESTED
THE SCIENTISTS IN THAT GROUP.
YOU'D BE SURPRISED.
THAT FURTHER CALLED FOR THEM TO
DEVELOP MODULES FOR THE
SCIENTISTS ON THESE SPECIFIC
TARGETED ISSUES, AND NOW WE SEE
IN THE SECOND GENERATION TOWARDS
E BRAINS, A COMMUNITY OF
RESEARCHERS READY TO BE ENGAGED.
IT'S NOT FREE OF PROBLEMS.
THEY HAVE HAD A LOT OF
CHALLENGES TOO BUT IT'S
INTERESTING MODEL.
I GUESS AS FAR AS SCOPE I THINK
I'M CLEAR ABOUT THINKING ABOUT
WHAT BRAIN RESEARCHERS WANT AND
NEED, BUT ALSO A QUESTION
WHETHER WE WANT TO THINK ABOUT
FORESIGHT AND FOUNDATIONAL
ISSUES BECAUSE IF WE'RE GOING TO
DO THOSE THINGS WE MIGHT HAVE
BROADER REACH, PARTICULARLY
WALTER KEPT PUSHING US TO ASK
ABOUT MISUSE, AND CHRISTINE ALSO
ASKED ABOUT THAT TOO.
YOU COULD SEE IT WAS QUITE
DIFFICULT FOR THEM TO GO BEYOND
HARM, LIKE THE TYPICAL RCR
COMPLIANCE TRAINING THAT WE
REQUIRE PEOPLE TO TAKE.
SO I THINK THAT'S A NON-TRIVIAL
ISSUE FOR US TO DISCUSS.
>>THANKS, KAREN.
THAT'S HELPFUL.
I AGREE, WE ALL AGREE ON SCOPE
STARTING WITH AT LEAST BRAIN,
RIGHT?
THAT'S PART OF WHY WE ROOTED
THIS CONVERSATION IN BRAIN,
GOING FORWARD OBVIOUSLY THAT'S
WHERE IT COULD BE MOST IMPACTFUL
AND HELPFUL.
AGREED ALSO WE NEED TO FIGURE
OUT FROM THE RESEARCHER'S
PERSPECTIVE, PROGRAM OFFICERS'
PERSPECTIVE, WHAT ARE THE BIG
QUESTIONS.
BUT PART OF IT IS FORESIGHT,
KAREN, FORESIGHT WITH RESPECT TO
THE EMERGING ETHICAL ISSUES THAT
ARE BEYOND RCR, AND HELPING TO
HAVE FORESIGHT WITH RESPECT TO
WHAT THOSE ISSUES ARE.
CHRISTINE WILL SHARE WITH US
HERE JUST THE SLIDES FROM BRAIN
2.0, BUT LET ME SUGGEST BASED ON
THIS CONVERSATION GIVEN WE'RE IN
THE EARLY STAGES OF IT MAYBE A
WORKSHOP IS A GOOD NEXT STEP FOR
US TO FLESH OUT THESE ISSUES,
DOESN'T SOUND LIKE WE'RE READY
TO COALESCE AROUND CO-CREATED
PAPER OR SOMETHING TO THAT
EFFECT.
SO I'M PUTTING THAT OUT THERE
FOR A TEMPERATURE CHECK TO SEE
HOW PEOPLE FEEL ABOUT THAT AS A
POSSIBILITY FOR MOVING AHEAD.
CHRISTINE, WILL YOU SHARE THAT
IN THIS IS A DEEP DIVE,
COMPREHENSIVE WITH JUST 8
MINUTES REMAINING WE'RE NOT
GOING TO GO THROUGH ALL OF IT
BUT JUST REFRESH OUR
RECOLLECTION AS TO THE ISSUES ON
THIS.
>>SURE.
I THINK IT MIGHT TAKE US IN A
DIFFERENT DIRECTION BUT I'LL PUT
THEM UP BECAUSE IT IS WORTH
SEEING.
THIS IS FROM JANUARY OF 2021.
SO TWO YEARS AGO.
>>I WONDER IF YOU COULD DO IT
AS A SLIDE SHOW BECAUSE IT'S
SMALL.
>>I CAN.
IT TAKES ME A MINUTE TO FIGURE
IT OUT.
CAN YOU SEE THAT?
>>YES, GREAT.
>>SO, THIS WAS TWO YEARS AGO.
AND WE ASKED OURSELVES SOME OF
THE SAME QUESTIONS.
>>CAN YOU FLIP THE SCREEN?
>>WHAT THE SCREEN?
MAYBE.
>>YOU'RE IN PRESENTER MODE.
>>THAT WAY?
>>YEP, YEP.
>>OKAY.
WE WERE ASKING OURSELVES WHAT WE
SHOULD DO THEN.
THIS WAS THE SORT OF SUMMARY OF
THE ENTIRE SET OF CHAPTERS
WITHIN THE ROADMAP.
NO, SORRY.
THIS IS THE CHARGE TO THE
NEUROETHICS WORKING GROUP,
REMIND THE PEOPLE WHAT OUR
CHARGE WAS.
PRETTY FAMILIAR, I WON'T READ
THEM.
YOU CAN SEE IT IS A VERY USEFUL
SET OF REMINDERS.
THESE WHY THE CATEGORIES FROM
THE ROADMAP.
JIM, JUMP IN IF THERE'S ANYTHING
YOU SEE TO HIGHLIGHT.
THESE WERE THE CHAPTERS.
AND THEN WE LISTED, AGAIN THIS
IS -- WE LISTED SOME THINGS THAT
WERE INCLUDED IN THE CONCEPTUAL
AND EMPIRICAL SPACE, BACK FROM
THE ROADMAP INCLUDING EQUITY,
PRIVACY, VULNERABILITY,
LONG-TERM OBLIGATIONS, ANIMAL
MODELS.
AND OF COURSE HAD SOME VERY
SPECIFIC EXAMPLES OF THINGS
UNDER THOSE CATEGORIES.
I'LL GIVE YOU A MINUTE TO LOOK
AT THEM WITHOUT READING THEM.
AND THEN WE ASKED THIS QUESTION
WE HAD SOME IDEAS FOR GUIDANCE
NOT CALLED GUIDANCE, THINGS WE
COULD THINK ABOUT SPECIFICALLY
FOR RESEARCHERS RELATED TO THE
DESIGN OF RESEARCH AND CONDUCT
OF RESEARCH.
IF I'M GOING TOO FAST, TELL ME.
WE HAD IDEAS OF IMPROVEMENT AND
GUIDANCE FOR REGULATORS,
POLICYMAKERS, IRBs, FUNDERS.
>>INTERESTING WE DON'T HAVE
ANYTHING ON MODULATING CHANGING
ON THE BRAIN.
>>WE DON'T.
I MEAN, OTHER THAN THE SORT
OF -- THERE WAS GENERAL STUFF N
RISK BUT IT WASN'T SPECIFIC.
ETHICAL FRAMEWORKS.
RESOURCES.
INTEGRATING NEURAL SCIENCE AND
NEUROETHICS.
AND TRAINING IDEAS.
AND PUBLIC ENGAGEMENT.
WE ALSO HAD I THINK THE LAST
SLIDE -- OH, HERE WE GO.
POSSIBLE NEWG ACTIVITIES.
RECOMMENDING RESEARCH TOPICS,
HOLDING WORKSHOPS, SUPPORTING
CHANGES TO NEUROSCIENCE RESEARCH
OR REVIEW, AND ENDORSING
TRAINING AND INTEGRATION OF
PUBLIC ENGAGEMENT.
I THINK THERE'S A SLIDE -- I
THOUGHT THERE WAS ONE ON THE
TRANSFORMATIVE IDEAS THAT JIM
WILL REMEMBER.
>>YEAH, MAYBE I COULD JUMP IN
FOR A MOMENT, CHRISTINE.
THIS IS A GOOD HELICOPTER VIEW
OF THE REPORT BUT THERE WAS VERY
LITTLE ON CHAPTER 6, WHICH IS
WHAT ACTUALLY PRIMARILY DEALT
WITH WHAT WE DISCUSSED TODAY.
THERE ARE THINGS WITH RESPECT TO
BRAIN STIMULATION, EARLIER
CHAPTER, I THINK CHAPTER 2.
I ENCOURAGE PEOPLE TO LOOK AT
CHAPTER 6 IN PARTICULAR, AND
CHAPTER 5 AS KAREN MENTIONED,
DEALING MORE WITH THE ISSUE OF
DIFFERENT RANGE OF TECHNOLOGIES
IN PARTICULAR CONSUMER POTENTIAL
TECHNOLOGIES, SUCH AS VR AND
TRYING TO, YOU KNOW, ASSESS SOME
OF THE ISSUES THAT MIGHT COME UP
AND SOME PARTICULAR
RECOMMENDATIONS SO THOSE WEREN'T
SPECIFICALLY IN THIS
PRESENTATION SINCE CHAPTER 6
SEEMED TO BE A LITTLE BIT BEYOND
WHAT NEWG MIGHT BE ADDRESSING AT
THE MOMENT WHEN THIS WAS PUT
TOGETHER.
>>I THINK IT ALSO GOES BACK TO
SOMETHING WE JUST DISCUSSED
TODAY.
I DO HAVE NOTES ON THESE THINGS
THAT SAID, YOU KNOW, SOME OF THE
TOPICS RAISED IN CHAPTER 6 WERE
SPECIFICALLY ABOUT USING NEURAL
TECHNOLOGIES OUTSIDE OF THE
CLINICAL SPACE, YOU KNOW, IN
EDUCATION, LEGAL AREAS, ET
CETERA, EMPLOYMENT, NATIONAL
SECURITY.
AND THE DISCUSSION AT THE TIME
WE DISCUSSED THIS A COUPLE YEARS
AGO WAS THAT WAS OUTSIDE THE
SCOPE OF BRAIN.
>>WELL, THAT'S A LOT FOR US TO
DIGEST.
WE PUT A PARTICULAR TOPIC THAT
ISN'T ON THE CLEAR LIST THERE
BUT THIS GIVES US A LOT OF SCOPE
TO THINK ABOUT THAT.
I MIGHT SUGGEST THAT FOLKS -- WE
WON'T MAKE ANY DECISIONS I DON'T
THINK HERE IN A MINUTE AND 15
SECONDS, BUT I WOULD SUGGEST
THAT WE, YOU KNOW, RECIRCULATE
THAT POWERPOINT AND IT WOULD BE
TERRIFIC TO HAVE PEOPLE WEIGH IN
BY QUICK E-MAIL,ER WHO NEXT ST,
MODULATING, CHOOSING SOMETHING,
THINKING ABOUT SPECIFIC CONCRETE
IMPACTFUL CONTRIBUTIONS THAT WE
COULD MAKE IN NEWG FOR THE BRAIN
INITIATIVE.
KAREN, YOU GET THE LAST WORD ON
THIS TOPIC.
>>I WAS JUST GOING TO SUGGEST
ACTUALLY WORKSHOP FOR NEWG IN
ITS NEW COMPOSITION AND NEW
LEADERSHIP TO INTERNALLY THINK
ABOUT HOW TO ALIGN OUR DESIRED
IMPACT WITH THE EXPECTED IMPACT
THAT OUR STAKEHOLDERS MIGHT HAVE
FOR US, AND I THINK USING YOUR
RUBRIC OF THE THREE QUESTIONS
WOULD BE WONDERFUL AND ALSO
GOING BACK TO WHAT A LOT OF
GREAT STUFF THAT WAS IN THE
NEUROETHICS ROAD MAP.
THANKS AGAIN TO JIM, HEROIC
LEADER OF THAT EFFORT.
>>THANKS, KAREN.
THAT'S A GREAT SUGGESTION.
WE'LL SUGGEST EVERYBODY TAKE
THAT INTO CONSIDERATION AND ALSO
TAKE INTO CONSIDERATION THE
CONVERSATION TODAY AS WELL AS
WHAT RECIRCULATES, WEIGH IN ON
YOUR NEXT STEPS, MINI VIRTUAL
RETREAT AS WE DO EXACTLY THAT
WHICH IS TO FIGURE OUT OUR NEXT
STEPS TOGETHER.
SHOULD I CLOSE US OUT,
CHRISTINE?
OKAY.
WELL, THANK YOU, EVERYBODY, FOR
JOINING US TODAY.
THIS HAS BEEN A RICH AND
VALUABLE CONVERSATION,
STIMULATED A LOT OF THINKING AND
CHANGED MY BRAIN.
HA, HA.
I HOPE IT CHANGED ALL OF YOURS
IN WAYS THAT ARE BENEFICIAL.
AS ALWAYS, GRATEFUL FOR YOUR
TIME AND CONTRIBUTIONS, AND
SERVICE, IN THIS EFFORT.
THANKS, EVERYBODY.
LOOKING FORWARD TO THE CONTINUED
CONVERSATIONS ON THIS TOPIC.
>>COME BACK FOR THE CLOSED
SESSION.
>>WAIT, CHRISTINE, WE HAVE ONE
MORE ITEM ON THE AGENDA.
>>OH, YES, SORRY, SORRY.
NITA WILL RETURN THAT.
>>YOUR CHARTER IS WAITING FOR
YOU.
>>I'VE GOT TO GO, GREAT TO SEE
YOU ALL.
>>TAKE PICTURES, SEND PICTURES.
>>I WILL.
>>SO JUST BEFORE THE BREAK
WE'RE GOING TO DO OUR ROUNDTABLE
UPDATE TO SEE WHAT ALL THE NEWG
MEMBERS HAVE BEEN UP TO IN THE
SPACE.
SO I'LL CALL ON FOLKS ONE BY
ONE, FEEL FREE TO SHARE AND LET
US KNOW WHAT'S BEEN HAPPENING
SINCE THE LAST TIME WE MET.
NITA, WE'LL START WITH YOU.
>>THANKS, EVERYBODY.
I'VE ENJOYED A LOT OF RICH
CONVERSATIONS IN THE SPACE
AROUND NEUROTECHNOLOGIES, MOST
RECENTLY, AND THE LAST WEEK WAS
AT THE WORLD ECONOMIC FORUM IN
DAVOS WHERE I HAD AN OPPORTUNITY
TO PRESENT ON BRAIN TRANSPARENCY
AS A TOPIC, THERE WAS A LOT OF
INTEREST I THINK FROM DIFFERENT
STAKEHOLDERS ACROSS THE WORLD
ENGAGING ON THAT TOPIC, ALSO HAD
AN OPPORTUNITY TO ENGAGE IN A
PANEL ABOUT REIMAGINING HEALTH
CARE AND TRANSFORMATIVE ISSUES
IN THAT SPACE.
I THINK TOP OF MIND FOR A LOT OF
PEOPLE ARE ISSUES AROUND
PRIVACY, AND THINKING ABOUT DATA
SHARING AND HOW WE MIGHT MOVE TO
A PLACE IN WHICH DATA SHARING
COULD BE SOMETHING THAT IS DONE
CONFIDENTLY BY INDIVIDUALS WHILE
SAFEGUARDING AGAINST RISK OF
MISUSE.
THAT'S WHAT I'VE BEEN UP TO, AND
MY BOOK, THE BATTLE FOR YOUR
BRAIN, COMES OUT IN MARCH, I'LL
BE ON THE ROAD TALKING ABOUT
THAT OVER THE NEXT COUPLE OF
MONTHS.
>>WINSTON?
>>MAJOR UPDATES FOR ME IS I'VE
BEEN NAMED EXECUTIVE DIRECTOR OF
BIOETHICS AT UCSF, THINKING
ABOUT THE RELATIONSHIP BETWEEN
SOME QUESTIONS WE'RE ASKING IN
NEUROETHICS AND A LONG HISTORY
OF SCHOLARSHIP AND BIOETHICS
THAT IS OVERLAPPING.
SO, HOW TO INCORPORATE
PARTICULARLY AS WE'RE TALKING
ABOUT THINGS LIKE CLINICAL OR
HEALTH-RELATED APPLICATIONS OF
NEUROTECHNOLOGY, THERE'S A LOT
TO DRAW ON, AND THERE'S A LOT OF
OVERLAP ALSO WITH OUR COLLEAGUES
IN GERIATRICS AND PEDIATRICS,
YOU THINK ABOUT BRAIN
DEVELOPMENT THROUGHOUT THE
LIFESPAN.
>>THANKS, WINSTON.
JIM?
>>THIS WILL BE SHORT.
I HAVE NO NEUROETHICS UPDATE FOR
EVERYONE.
>>THANKS, JIM.
SYD?
>>I'VE HAD A COUPLE OF PAPERS
ON -- A PAPER AND A BOOK CHAPTER
ON BRAIN DEATH RECENTLY, AND
MONDAY I'LL BE IN D.C. FOR A
CONGRESSIONAL BRIEFING WHICH
I'VE NEVER DONE BEFORE, AND SO
KIND OF EXCITED AND ANXIOUS
ABOUT THAT.
THAT'S GOING TO BE ON ANIMAL
RESEARCH.
>>THANKS, SYD.
COME SAY HI TO NIH IF YOU'RE IN
THE AREA.
CAROLINE?
>>YEAH, THANK YOU, NINA.
A LOT OF UPDATES ACTUALLY COMING
FROM OUR SIDE.
IT'S BEEN A BUSY SET OF MONTHS
SINCE WE LAST MET.
MANY PEOPLE ON THE CALL ARE
AWARE THE DANA FOUNDATION
REFINED ITS MISSION TO ADVANCING
NEUROSCIENCE THAT BENEFITS
SOCIETY AND REFLECTS ASPIRATIONS
OF ALL PEOPLE, AND SO UNDER THAT
MISSION AREA WE'VE DEVELOPED OUR
THREE PROGRAMMATIC PILLARS,
PROGRAMMATIC STRATEGIES LED BY
KAREN RAMOS FORMERLY AT NIH,
VERY GLAD TO HAVE HER, ALSO THE
PROGRAMMATIC PILLARS ARE DINA
EDUCATION, NEXT GEN AND DINA
FRONTIERS, AND SO A FEW RELEVANT
I THINK NEWG UPDATES, JUST
UPDATES FROM THE NEUROETHICS
COMMUNITY, ONE OF THEM COMING
FROM THE DINA EDUCATION PILLAR
IS BRAIN AWARENESS WEEK WHICH
THE FOUNDATION SPONSORS, COMING
UP MARCH 13-19.
YOU MIGHT HAVE DIFFERENT
ACTIVITIES AT THAT TIME, SO WE
TRY TO HELP PROMOTE ALL OF THOSE
ACTIVITIES.
ANOTHER RELATED UPDATE IS COMING
FROM THE DINA NEXT GEN PROGRAM,
THE SIGNATURE OF THAT PROGRAM IS
THE CENTERS IN NEUROSCIENCE AND
SOCIETY WHICH I SHARED ABOUT
WITH EVERYBODY HERE DURING OUR
LAST MEETING, WE WERE VERY HAPPY
LAST FALL TO AWARD 11 PLANNING
GRANTS FOR THE DINA CENTERS, IN
THE PROCESS OF COMPLETING
DEMONSTRATION PROJECTS, TO
ILLUSTRATE THE SPIRIT OF THE
KIND OF WORK THE DINA CENTERS
SHOULD THEY BE ESTABLISHED THERE
WOULD BE UNDERGOING, AND SO THE
TIMELINE, PLAN TO SELECT TWO
CENTERS BY THIS COMING FALL.
AND WE -- A SHOUT OUT TO THE
SUMMIT HELD TODAY FUNDING GRANTS
APPLICANTS FROM HARVARD, HOSTED
A REALLY INTERESTING SET OF
TALKS THAT ARE RELATED TO SOME
OF THE WORK THEY WOULD BE
PROPOSING FOR A DANA CENTER, AND
FROM THE DANA FRONTIERS PROGRAM
FOCUSING ON GROWING CAPACITY FOR
INFORMED PUBLIC REFLECTION ON
NEUROSCIENCE AND NEUROSCIENCE IN
SOCIETY, SOMETHING THAT MIGHT BE
OF INTEREST TO FOLKS HERE IS A
PUBLIC POLLING -- PUBLIC SURVEY
WE DID IN COLLABORATION WITH
RESEARCH AMERICA, TO TEST OUR
ASSUMPTION, QUESTION OUR OWN
ASSUMPTION OF PUBLIC PERCEPTION
AND UNDERSTANDING AROUND
NEUROSCIENCE, INTERESTING FOR US
TO GO THROUGH THE PROCESS SO IT
COULD HELP INFORM OUR STRATEGY
AROUND WHAT THE NEEDS ARE IN
PUBLIC ENGAGEMENT.
WE FOUND THAT THERE'S A DESIRE
FOR AN INCREASE IN PATIENT
VOICES IN SETTING RESEARCH
PRIORITIES WHICH IS VERY
RELEVANT TO THE CONVERSATIONS
WE'VE BEEN HAVING TODAY.
AND SO I THINK THAT'S IT IN A
NUTSHELL SOME THINGS HAPPENING
HERE.
YOU'LL FIND OUT MORE ABOUT THIS
FROM A NEW WEBSITE THAT WE'RE
LAUNCHING THIS SUMMER
ENCAPSULATING VISION MISSION,
PILLARS AND ACTIVITIES THAT
WE'RE HAVING BUT IT'S ALL VERY
RELATED TO THIS GROUP AND WE'RE
SO EXCITED TO THINK ABOUT HOW WE
CAN COMPLEMENT AND PARTNER WITH
ALL OF YOU IN HELPING TO PUSH
FORTH THE ELEVATED VISIBILITY OF
THE NEEDS IN NEUROSCIENCE AND
SOCIETY.
I'LL END WITH THAT.
>>THANKS, CAROLINE.
KAREN?
>>GREAT.
I THINK WHAT I'D LIKE TO SHARE
ARE SOME UPDATES ON THE
INTERNATIONAL STAGE, AND THEN
ONE MORE NATIONALLY ORIENTED
UPDATE.
ON THE INTERNATIONAL FRONT
THERE'S BEEN A LOT OF DISCUSSION
IN REGULATION AND POLICY AND
GUIDANCE AROUND NEUROTECHNOLOGY
IN SPECIFIC, SEEMS TO BE
PROLIFERATING RAPIDLY MORE THAN
I'VE SEEN IN THE PAST.
WHAT YOU MAY HAVE HEARD ABOUT IS
AN INFAMOUS NEURAL RIGHTS
CONVERSATION, THAT PROPOSES
NOVEL HUMAN RIGHTS RELATED TO
NEUROTECHNOLOGY AND
NEUROSCIENCE.
AND IN I THINK IT WAS NOVEMBER
OR DECEMBER THE UNESCO
INTERNATIONAL BIOETHICS
COMMUNITY CREATED A
NEUROTECHNOLOGY REPORT THAT
TALKED ABOUT A NUMBER OF
RECOMMENDATIONS FOR
NEUROTECHNOLOGY, SOME RESONATE
WITH SOME OF THE ACTIVITIES
WE'VE PROPOSED IN WHAT CHRISTINE
SHOWED, BUT ALSO CONCLUDES
THERE'S NO NEED FOR NEW RIGHTS
BUT A NEED TO TAILOR EXISTING
REGULATION.
NITA SPOKE AT OECD EVENT, DO WE
NEED NEURAL RIGHTS, THAT WAS
FINALIZED IN EARLIER -- ACTUALLY
IN DECEMBER, EARLIER THIS YEAR,
COMING OUT SOON WITH A SERIES OF
VIDEOS AND, AGAIN, THE
FINDING
IS THE SAME.
AROUND DATA, MAYBE OUR
CONVERSATION HERE TODAY IS MORE
RELEVANT THAN WE MIGHT
ANTICIPATE.
AND SO WE DO KNOW THAT ACTUALLY
YOU MAY BE AWARE MANY OF YOU
WERE INVOLVED IN OECD
RECOMMENDATION ON RESPONSIBLE
INNOVATION AND NEUROTECHNOLOGY
ADOPTED AS A LEGAL INSTRUMENT IN
DECEMBER 2019, BY 2024 ALL
MEMBER COUNTRIES ARE -- ALL 38
MEMBER COUNTRIES ARE EXPECTED TO
DEMONSTRATE HOW THEY HAVE
IMPLEMENTED THIS DOCUMENT.
OECD CONSIDERS THIS FIRST
INTERNATIONAL STANDARD IN
RESPONSIBLE INNOVATION IN
NEUROTECHNOLOGY BUT REALLY IT'S
A BUNCH OF PRINCIPLES THAT NEED
TRANSLATION AND IMPLEMENTATION.
SO WE'VE JUST WORKED THROUGH THE
FIRST IMPLEMENTATION GUIDE WHICH
SHOULD BE -- IS BEING FINALIZED
TO BE FORTH COMING SOON.
I WON'T MENTION OTHER ENTITIES
AND WILL GO STRAIGHT TO
NATIONAL.
FEBRUARY 16 AND 17 THE
DEPARTMENT OF COMMERCE, SOME OF
YOU WILL BE INVOLVED IN THAT
EVENT, HOSTING A WORKSHOP,
PUBLICLY WEBCAST EVENT ON BCI
EXPERT CONTROL REGULATION,
WHAT'S THE STATE OF THE ART AND
WHAT MIGHT BE NEEDED FOR EXPERT
CONTROL REGULATION, AND THERE
WILL NEED TO BE MORE RELATED TO
THAT.
I DON'T THINK YOU CAN FIND
ANYTHING ONLINE ABOUT IT YET BUT
THEY DO HAVE THEIR CALL FOR
COMMENT IN THE FEDERAL REGISTER
FOR BCI EXPERT CONTROL CLOSED
NOVEMBER 21, COMPILED RESPONSES,
DIDN'T GET A LOT LIKE WE DON'T
GET A LOT WHEN WE ASK FOR
RESPONSES AT NIH, AND THEN ARE
TRYING TO FIGURE OUT HOW TO
ENGAGE MORE OF A BROAD AUDIENCE
FOR THIS EVENT.
THAT'S IT.
>>THANKS, KAREN.
ELBA?
>>SORRY I'M LATE.
THIS IS A BIG TEACHING DAY FOR
ME.
GOOD TO SEE EVERYBODY.
WHAT I HAVE TO SHARE IS
TANGENTALLY RELATED, THE SOCIETY
FOR NEUROSCIENCE OFFERS RESPONSE
CONDUCT IN RESEARCH WORKSHOPS,
THE ONE IN THE FALL WAS
OUTSTANDING.
IT WAS ON DATA SCIENCE, DATA
MANAGEMENT, DATA CURATION, RIGOR
AND REPRODUCIBILITY, PROTECTION,
ALL THE ISSUES THAT ARE JUST
GOING TO ESCALATE REGARDING THE
AVAILABILITY OF DATA,
ORGANIZATION OF DATA, META DATA
TAGGING AND OF COURSE PROTECTION
OF HUMAN SUBJECTS DATA.
I'LL POST THAT IN THE CHAT AND I
DON'T KNOW IF THERE WOULD BE AN
OPPORTUNITY FOR THIS COMMUNITY
OR THIS GROUP TO PERHAPS
SPONSOR, ASSEMBLE ON A PAGE
SCIENTISTS DEALING WITH DATA.
I CANNOT PUBLISH ANYTHING
WITHOUT MAKING ALL THE DATA
AVAILABLE ON A WEBSITE LIKE
DRYAD, SO THIS IS A NEW
REQUIREMENT AND IT'S A REALLY
IMPORTANT ONE.
SO THAT'S IT.
>>THANKS, ELBA.
AND SAMEER?
>>YEAH, TWO QUICK THINGS.
THERE'S APPARENTLY A FLASH FLOOD
OUTSIDE MY WINDOW, TWO INCHES OF
WATER, THIS WILL BE FUN.
THE OTHER ONE MORE RELEVANT IS
IN PARALLEL, I HAD THE PLEASURE,
REALLY LEARNED A LOT FROM
WORKING WITH A PARALLEL GROUP,
NEUROETHICS WORKING GROUP IN A
BRANCH WITHIN "BRAIN," WE PUT
OUT A PAPER A YEAR AGO, NOW
WE'RE OFF TO THE NEXT PROJECT, A
FUN PROJECT, LOOKING AT ISSUES
AROUND DATA SHARING, DATA REUSE,
WHAT ARE THE ADVANTAGES,
DISADVANTAGES FROM ALL THE
DIFFERENT PERSPECTIVES.
DOING THIS WITH AMY MAGUIRE
HERE, DIRECTOR OF CENTER FOR
MEDICAL ETHICS AT BAYLOR WHO I
WORK WITH A LOT THROUGH THE
SHARED R01, BRAIN SHARE THROUGH
BRAIN, THIS IS NEAT BECAUSE IT
ADDRESSES A LOT OF ISSUES WE
TALKED ABOUT TODAY, A COUPLE
THINGS IN THE CHAT, AND SPANS A
BUNCH OF AREAS, WE'RE FOCUSING
LARGELY ON THE ROH ITSELF,
INVASIVE OPPORTUNITIES IN HUMANS
TO LEARN HOW THE BRAIN WORKS,
AND THINGS WE'VE TALKED ABOUT
EVEN RELATED TO THIS DEPRESSION
PROJECT, DATA THAT COMES FROM
THIS, HOW IS IT USED, HOW SHOULD
IT BE USED, WHO HAS ACCESS, WHO
OWNS IT, AND HOW CAN WE
INCENTIVIZE REUSE OF DATA, FROM
THE PERSPECTIVE OF INVESTIGATORS
AND JOURNALS, THE PUBLIC,
PATIENT, PARTICIPANTS, ET
CETERA.
THIS IS ONGOING.
WE HAVE A WORKING GROUP ASSIGNED
TO THIS, IN THE PROCESS OF
SKETCHING OUT A DRAFT WITH
CERTAIN CASE USES, PERHAPS THREE
SPECIFIC CASE USES THAT SPAN
DIFFERENT ASPECTS OF THIS TOPIC.
STAY TUNED.
NEXT TIME WE MEET IT WILL BE
PUBLISHED HOPEFULLY.
PROBABLY NOT.
BUT FURTHER THAN IT IS NOW.
>>I'M GOING TO TOSS TO SASKIA
BRIEFLY.
>>IT MIGHT BE A GOOD TIME TO
MENTION WE'RE WORKING A WORKSHOP
FOR THE NEUROETHICS WORKING
GROUP RELATED TO DATA AND
PRIVACY AND DATA SHARING.
WE'RE HOPING TO HAVE IT THIS
SUMMER, I THINK THE SAVE THE
DATES WILL GO OUT SOON-ISH.
YEAH, WE HOPE TO PULL TOGETHER
ALL OF THE THREADS THAT WE'VE
HEARD IN THE LAST COUPLE OF
MINUTES ABOUT DATA AND PRIVACY.
>>THANKS.
YEAH, STAY TUNED.
I'LL TURN IT NOW OVER TO JOHN
AND ANDREA TO CLOSE US OUT.
>>GO AHEAD, JOHN.
I'LL DO THE HOUSEKEEPING WHEN
YOU'RE DONE.
>>YOU'LL HAVE THE TIME WORD,
THE IMPORTANT PART.
THANKS.
IT'S BEEN A GREAT SET OF
DISCUSSIONS, AND REALLY ENJOYED
THE PRESENTATIONS AND
DISCUSSIONS THAT FOLLOWED.
I THINK WE SURFACED A LOT OF
IMPORTANT ISSUES, AND I ASK YOU
AS YOU LEAVE HERE AND THINK
ABOUT WHAT WE TALKED ABOUT IN
TERMS OF WHAT CAN NEWG DO AND
HOW CAN NEWG HELP TO CONSIDER
THE THINGS THAT CAME UP ABOUT
ONE BEING KIND OF LET'S -- WE
CAN START WITH BRAIN AS OUR
FOCUS, NOT TO SAY THAT WE
WOULDN'T WANT THE IMPACT TO BE
MUCH LARGER BUT ONE COOL THING
ABOUT THE BRAIN INITIATIVE, SOME
THINGS WE START HERE ARE
APPLICABLE MORE PRODUCTLY IN NOT
JUST NEUROSCIENCE BUT ACROSS
BIOMEDICINE, FOR EXAMPLE MANY
ISSUES COMING UP ACUTELY IN THE
POST-TRIAL SPACE ARE DISCUSSED
ACROSS NIH AND BIOMEDICINE.
AND AGAIN TO THINK ABOUT THIS AS
A NEUROSCIENCE INITIATIVE WHERE
WE'RE LOOKING AT BUILDING TOOLS
ETHICALLY TO UNDERSTAND
MECHANISM AND IF YOU UNDERSTAND
MECHANISM YOU GET A LOT FURTHER
IN ALL WE DO.
AND FINALLY I THINK BRAIN
INITIATIVE FROM THE OUTSET HAS
MADE THE ETHICAL CONSIDERATIONS
TO BE INTEGRAL TO WHAT WE DO AND
HENCE WHY WE'RE ALL HERE TODAY
AND REALLY THE VALUE OF THE NEWG
AND HOW CAN WE MORE FULLY
INTEGRATE THESE VIEWS INTO THE
RESEARCH NOT AS AN ADD-ON AT THE
END BECAUSE BY THEN WE ALL KNOW
IT'S TOO LITTLE TOO LATE.
WE CAN WORK TOWARDS AN
INTERESTING AND PRODUCTIVE
CONVERSATION IN THE FUTURE,
WHETHER HERE AT NEWG MEETINGS OR
IN WRITING UP SOME SCHOLARLY
PAPERS, TRYING TO FIGURE OUT OR
TO SOLICIT INTERESTING
APPLICATIONS TO FUND IN THE
NEUROETHICS SPACE AND ALSO OF
COURSE HOLDING WORKSHOPS THAT
DIG IN DEEPER.
WE LOOK FORWARD TO YOUR INPUT AS
WE CHART FORWARD IN THE NEXT
YEAR PLUS.
I'LL HAND IT OVER TO ANDREA WITH
MY THANKS FOR YOUR PARTICIPATION
AND ATTENTION TODAY.
>>JOHN GETS THE MORE FUN
CLOSING REMARKS.
MY JOB IS TO LET YOU KNOW THAT
WE ARE CONCLUDING THE OPEN
SESSION OF THE NEUROETHICS WORK
GROUP, TRANSITIONING TO CLOSED
SESSION AT 45 MINUTES PAST THE
HOUR, THE ZOOM ROOM WILL BE OPEN
EARLY TO GET STARTED ON TIME.
FOR NEWG MEMBERS, INVITED
GUESTS, YOU HAVE A SEPARATE LINK
IN YOUR MEETING INVITATION OR
E-MAIL OR PROBABLY BOTH.
ALSO A QUICK PLUG, MULTI-COUNCIL
WORK GROUP TOMORROW, OPEN
SESSION AT NOON EASTERN TIME.
SO FOR NOW WE ADJOURN OUR OPEN
SESSION, AND WE WILL SEE NEWG
MEMBERS FOR CLOSED SESSION AGAIN
AT 45 MINUTES PAST THE HOUR.
THANK YOU ALL.