Landscapeanalysisofthe

opportunitiesandchallengesfor

neurotechnology

inglobalhealth

Landscapeanalysisofthe

opportunitiesandchallengesfor

neurotechnology

inglobalhealth

worldHealthorganization

LandscapeanalysisoftheopportunitiesandchallengesforneurotechnologyinglobalhealthISBN978-92-4-010904-9(electronicversion)

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v

Contents

Acknowledgements vii

Abbreviations ix

Executivesummary x

1.Introduction 1

2.Objectivesandmethodology 2

2.1Objectives 2

2.2Landscapeanalysismethodology 2

2.2.1Developingtheresearchquestion 2

2.2.2Developingthemethod 3

2.2.3Collectingthedata 3

2.2.4Analysingandvisualizingtheresults 3

2.2.5Disseminatingthefindings 3

2.3Expertconsultation 4

2.4Limitationsofthelandscapeanalysis 4

3.Latestdevelopmentsandstateofneurotechnology 5

3.1Neuroimaging 5

3.1.1Introduction 5

3.1.2Latestdevelopmentsofneuroimaginginhumanhealth 5

3.1.3Keyfundingandinitiativesinthedevelopmentofneuroimaging 5

3.2Brain-computerinterface(BCI) 6

3.2.1Introduction 6

3.2.2LatestdevelopmentsofBCIinhumanhealth 6

3.2.3KeyfundingandinitiativesinthedevelopmentofBCI 6

3.3Neuromodulation 6

3.3.1Introduction 6

3.3.2Latestdevelopmentsofneuromodulationinhumanhealth 7

3.3.3Keyfundingandinitiativesinthedevelopmentofneuromodulation 7

3.4Neurologicaldevices 7

3.4.1Introduction 7

3.4.2Latestdevelopmentsofneurologicaldevicesinhumanhealth 7

3.4.3Keyfundingandinitiativesinthedevelopmentofneurologicaldevices 8

4.Challengesandconsiderationsinneurotechnology

translationandimplementation 9

4.1Developmentandregulatoryapprovaltowardsclinicaluse 9

4.2Accessibilityoftechnologiesonaglobalhealthscale 9

4.2.1Accessibilityofneurotechnologyfacilitiesandresources 9

4.2.2Generalizabilityoftechnologiestoglobalpopulations 10

4.2.3Currentstrategiesinimprovingaccessibilityofneurotechnology 11

4.3Safetyanddual-useconsiderations 11

4.3.1Safetyconcerns 12

4.3.2Dual-useresearch 12

5.Conclusion 14

6.Summarytable 15

References 16

vi

vii

Acknowledgements

ThislandscapeanalysiswasdevelopedaspartofacollaborationbetweentheEmergingTechnologiesResearchPrioritisationandSupport(EPS)unitoftheWorldHealthOrganization(WHO)Research

forHealthDepartment(ScienceDivision)with

theBrainHealthunit,theGlobalHealthEthicsandGovernanceunitandtheAgeingandHealthunit,undertheoverallguidanceofAnnaLauraRoss(UnitHead,EPS)andJohnReeder(Director,DepartmentofResearchforHealth).

SeanChia(Consultant)wastheleadwriter,with

supportandcoordinationofEmmanuelleTuerlings(TechnicalOfficer,EPS)andRodrigoCataldi(MentalHealthOfficer,BrainHealthunitinDepartmentofDepartmentofMentalHealth,BrainHealthand

SubstanceUse).

Thisdocumentwasdevelopedwiththeinput

gatheredfromtwomeetingsthatbroughttogetherexpertsinneurotechnology,ethicists,and

representativesfromgovernments,publichealthbodies,academiaandinternationalorganizations.WHOexpressesitssincereappreciationtoall

expertsfortheircontributionsandinputstothedevelopmentofthislandscapeanalysisthroughtheirparticipationatthesemeetings.

WHOconsultationforthelandscapeanalysisofthelateststatusof

neurotechnologywithaglobalhealthperspectiveon1October2024:

AndreaBeckel-Mitchener,NationalInstitutes

ofHealth,Bethesda(Maryland),UnitedStates

ofAmerica(AnyUSAcontributionsweremade

before20January2025);SahbaBesharati,

UniversityoftheWitwatersrand,Johannesburg,SouthAfricaandUniversityofSassari,Sassari,

Italy;AnitaCicero,JohnsHopkinsUniversity,

Baltimore(Maryland),UnitedStatesofAmerica

andmemberofWHOTechnicalAdvisoryGroupontheresponsibleuseofthelifesciencesanddual-useresearch;KarenHerrera-Ferrá,Asociación

MexicanadeNeuroética,MexicoCity,Mexico;DafnaFeinholz,UnitedNationsEducational,

ScientificandCulturalOrganization(UNESCO),

Paris,France;LauraVictoriaGarcia,Organisation

forEconomicCo-operationandDevelopment

(OECD),Paris,France;JudyIlles,Universityof

BritishColumbia,Vancouver,Canada;ZoeKourtzi,UniversityofCambridge,UnitedKingdomofGreatBritainandNorthernIreland;SilvestroMicera,

EcolePolytechniqueFédéraledeLausanne(EPFL),Lausanne,SwitzerlandandSant'AnnaSchoolof

AdvancedStudies(SSSA),Pisa,Italy;Abdelkader

NasreddineBelkacem,UnitedArabEmirates

University,AlAin,UnitedArabEmirates;Mu-mingPoo,ChineseAcademyofSciences,Shanghai,

China;PhilippeRyvlin,UniversityofLausanne

andtheLausanneUniversityHospital,Lausanne,

Switzerland;ChahnezCharfiTriki,Hedichaker

Hospital,SfaxUniversity,Sfax,Tunisia;Nikolaus

Weiskopf,MaxPlanckInstituteforHumanCognitiveandBrainSciences,Leipzig,Germany.

WHOdialogueforthelandscapeanalysisonneurotechnologyanddual-use

researchon5November2024:

AndreaBeckel-Mitchener,NationalInstitutesof

Health,Bethesda(Maryland),UnitedStatesof

America(AnyUSAcontributionsweremadebefore20January2025);SahbaBesharati,UniversityoftheWitwatersrand,Johannesburg,SouthAfrica

andUniversityofSassari,Sassari,Italy;RoongrojBhidayasiri,ChulalongkornUniversityandKing

ChulalongkornMemorialHospital,ThaiRed

CrossSocietyandTheRoyalSocietyofThailand,

Bangkok,Thailand;AnitaCicero,JohnsHopkins

University,Baltimore(Maryland),UnitedStatesofAmericaandmemberofWHOTechnicalAdvisoryGroupontheresponsibleuseofthelifesciencesanddual-useresearch;MalcolmDando,UniversityofBradford,UnitedKingdomofGreatBritainandNorthernIreland;KarenHerrera-Ferrá,AsociaciónMexicanadeNeuroética,MexicoCity,Mexico;JudyIlles,UniversityofBritishColumbia,Vancouver,

Canada;AbdelkaderNasreddineBelkacem,UnitedArabEmiratesUniversity,AlAin,UnitedArab

Emirates;IngaUlnicane,UniversityofBirmingham,Birmingham,UnitedKingdomofGreatBritainandNorthernIreland.

viii

WHOisgratefultothefollowing

individualswhoprovidedtechnicalcontributionsandreviewedthe

landscapeanalysis:

SahbaBesharati,UniversityoftheWitwatersrand,Johannesburg,SouthAfricaandUniversityof

Sassari,Sassari,Italy;MarcelloIenca,TechnicalUniversityofMunich,München,Germany;

ZoeKourtzi,UniversityofCambridge,United

KingdomofGreatBritainandNorthernIreland;FilippaLentzos,King’sCollegeLondon,London,UnitedKingdomofGreatBritainandNorthern

Ireland;AbdelkaderNasreddineBelkacem,

UnitedArabEmiratesUniversity,AlAin,UnitedArabEmirates;PhilippeRyvlin,Universityof

LausanneandtheLausanneUniversityHospital,Lausanne,Switzerland.

Allexternalmeetingexpertsandreviewers

declaredtheirinterestsinlinewithWHOpolicies.Noneoftheinterestsdeclaredwereassessedtobesignificant.

WHO

KennethCarswell,MentalHealthSpecialist,MentalHealthUnit,DepartmentofMentalHealth,Brain

HealthandSubstanceUse;SarahCharnaud,

TechnicalOfficer,EmergingTechnologies,ResearchPrioritisationandSupportunit,Department

ofResearchforHealth;NeerjaChowdhary,

TechnicalOfficer,BrainHealthunit,DepartmentofMentalHealth,BrainHealthandSubstance

Use;MatteoCesari,Scientist,AgeingandHealth

unit,DepartmentofMaternal,Newborn,Child,

AdolescentHealthandAgeing;TarunDua,Unit

Head,BrainHealth,DepartmentofMental

Health,BrainHealthandSubstanceUse,Geneva;LauraGarciaDiaz,Consultant,BrainHealthunit,DepartmentofMentalHealth,BrainHealthand

SubstanceUse;GhassanKaram,ProjectManager,InternationalClinicalTrialsRegistryPlatform

(ICTRP),EmergingTechnologies,Research

PrioritisationandSupportunit,Departmentof

ResearchforHealth,Geneva;KatherineLittler,

co-leadoftheHealthEthicsandGovernanceunit,DepartmentofResearchforHealth;Soatiana

Rajatonirina,TechnicalOfficer,Emerging

Technologies,ResearchPrioritisationandSupportunit,DepartmentofResearchforHealth;Anna

LauraRoss,UnitHead,EmergingTechnologies,

ResearchPrioritisationandSupport,DepartmentofResearchforHealth;KatrinSeeher,Mental

HealthSpecialist,BrainHealthunit,DepartmentofMentalHealth,BrainHealthandSubstanceUse;SebastianWinter,Consultant,BrainHealthunit,DepartmentofMentalHealth,BrainHealthand

SubstanceUse.

Thelandscapeanalysiswasconductedwiththe

financialsupportoftheGoodVenturesFoundation,OpenPhilanthropy.

Abbreviations

ABIDEAutismBrainImagingDataExchange

ADNIAlzheimer’sDiseaseNeuroimagingInitiative

AIArtificialIntelligence

BCIBrain-computerinterface

DARPADefenseAdvancedResearchProjectsAgency(UnitedStates)

DURDual-useresearch

ENIGMAEnhancingNeuroimagingGeneticsthroughMeta-Analysis

EPSEmergingTechnologies,ResearchPrioritisationandSupport

INDIInternationalNeuroimagingData-sharingInitiative

LMICsLow-andmiddle-incomecountries

MLMachinelearning

MRIMagneticresonanceimaging

OECDOrganisationforEconomicCo-operationandDevelopment

UNESCOUnitedNationsEducational,ScientificandCulturalOrganizationWHOWorldHealthOrganization

`

`

ix

x

Executivesummary

Thisreportprovidesadetailedexaminationofthe

currentlandscapeofneurotechnology,specifically

exploringbothitspotentialbenefitsandchallengesfromaglobalhealthperspective.Thelandscape

analysisfocusesonfouremergingsubcategoriesofneurotechnology,namely:neuroimaging,thebrain-computerinterface(BCI),neuromodulation,and

neurologicaldevices.

Toconductthelandscapeanalysis,acriticalreviewoftheliteratureandassociatedpublicationswas

carriedouttogleanthelatestadvancementsin

variousneurotechnologysubcategories.In

addition,twoconsultationswereheldwithexpertsandstakeholdersinordertounderstandtheir

perspectivesonvariousaspectsofneurotechnologydevelopmentanddeployment.

Clinicalapplicationofthevarioussubcategories

ofneurotechnologyhasundergonerapid

advancementinrecentyears–especiallywiththesupportofmoresophisticatedcomputationand

engineeringtechnologies.Forinstance,intheareaofneuroimaging,thedevelopmentofmethodsforhigherresolutionacquisition,aswellasmodels

basedonartificialintelligenceandmachinelearningtodeciphercomplexsignalsandpatterns,has

allowedfortheexpansionofclinicalapplications–especiallyindiagnosticsandtreatmentresponse

assessment.ForBCI,despiteitsrelativelyrecent

development,theseinterfaceshavealready

demonstratedclinicalutility,suchassupporting

therestorationofmotorfunctionandassistive

rehabilitation.Inthecaseofneuromodulation,

growthhasbeenwitnessedthroughitsextended

applicationtootherneurologicalconditions,

includingmovementdisorders,neuropsychiatric

conditionsandpainsyndromes.Additionally,

neurologicaldeviceshavealsobeendeveloped

toincludebettersensorsandrobotics,aswell

astheincorporationofdigitaltechnologiesand

wearabledevices.Severalkeyinitiativesandfundingstrategieshavecontributedtoadvancingclinical

translationandimplementationoftheseareasof

neurotechnology,notablythereleaseoflarge-scaledatasetstodrivedevelopmentwithinthefield,aswellasprivate–publicpartnershipstofurtherthelevelsoftechnologyreadinessofnovelsolutions.

However,whileneurotechnologyhasshown

feasibilityincasestudiesforvariousneurological

conditions,large-scaleclinicalvalidationstudies

demonstratingtheefficacyofneurotechnology

inclinicalsettingsremainlimited.Importantly,

accessibilityremainsasignificantchallengein

translatingandintegratingneurotechnology

applicationsintoexistingclinicalworkflowsand

settings.Coreissuesrelatetoinfrastructureand

resourcerequirements,aswellastheapplicabilityandgeneralizabilityofsuchapplicationsto

populationsglobally,particularlyinlow-andmiddle-incomecountries(LMICs).Humanandpublicsafetyanddual-useimplicationsinneurotechnology

constituteadditionalcriticalissues,withtheneedtonavigatethroughmaximizingbeneficialapplicationswhileminimizingharmfulones.Inlightofthese

concerns,strategieshavebeendevelopedrecentlytoimproveaccessibilityandtomitigatedual-useconsiderations,includingthedevelopmentofmorecost-efficientequipmentwithsimilarfunctionalityfortheformer,andincreasingawarenessfordual-usepotentialthroughkeypublications,reportsandworkshopsforthelatter.

Inconclusion,neurotechnologyhaswitnessed

arapidgrowthintermsofbothitstechnical

developmentanditsapplicationacrossvarious

neurologicalconditions.Tofacilitatetranslation

ofneurotechnologyadvancementstoclinical

settingsforthepopulationglobally,thereisa

needforlarge-scaleclinicaltrialsandbetter

infrastructuretosupportresearchanduptake,

includingworkforcetrainedonthesesophisticatedtechnologies.Additionally,developmentofcost-

efficientandportabletechnologieswouldsupporttheiraccessibility,especiallyinthecontextofLMICs.Overcomingidentifiedchallengesnecessitate

enhanceddatasharingandtheimplementation

ofethicalandregulatorysafeguardstoprotect

againstmisuse,ensurepatientsafety,andmitigatedual-useconcerns.Asimportantly,toensure

responsibleuseofneurotechnology,increasing

publicandpatientawarenessaboutthebenefits

andriskofneurotechnologyisneeded.Whileseveralavenuesandinitiativeshavebeenintroducedby

variousstakeholderstoadvanceneurotechnology

1

uptakeandovercomeidentifiedissues,the

successfuldevelopmentandimplementation

ofneurotechnologyrequiresacollaborative,

multiprongedandevidence-informedapproach.Jointeffortsbetweenresearchers,policy-makers,

industrystakeholdersandthepublicwillallowtheoverallresponsibleandbeneficialadvancementofneurotechnologytowardstheultimateimprovementofglobalhealthoutcomes.

CHAPTER1

Introduction

Advancesinlifescienceandassociatedtechnologyplayacriticalrolefornewandimprovedways

toaddressglobalhealth,supporthealthier

populationsworldwideandpromotinghealth

equityforalltoachievethehealth-relatedUnitedNationsSustainableDevelopmentGoals.Science

andtechnologyhaveanundisputedroleinworkingtowardsthe14thGeneralProgrammeofWorkof

theWorldHealthOrganization

(1)

.Theoverarchinggoalofthe14thGeneralProgrammeofWorkistopromote,provideandprotectthehealthandwell-beingofallpeople,everywhere.Neurotechnologyisemergingasanessentialtooltosupportactionstoaddresstheincreasingglobalburdenand

debilitatingimpactworldwideofneurologicaldisorderswhichnowcomprisetheleadingcauseofdisability-adjustedlifeyearsandprematuremortality

(2)

.

Forthepurposeofthislandscapeanalysis,

neurotechnologyisunderstoodasrepresentingmethodsordevicesthatcanrecord,interpretand/ormodulateneuralactivitywithinthecentralandperipheralnervoussystem.Itisarapidlygrowingareabothforbasicneuroscienceresearchand

fortranslationalworktowardsimprovinghumanhealth

(3–5)

.Inparticular,whileadvancementsinneurotechnologyhavedemonstrated

significanttherapeuticbenefitsforthoselivingwithneurologicalormentalhealthconditions,

unresolvedglobalhealthchallengesincludetheneedtoensureequitableaccesstothewider

community–particularlylow-andmiddle-incomecountries(LMICs)–aswellasmitigatingsafety

risks,ethicalconcerns,andthepotentialfordual-useofthesetechnologies.

Inlightofsuchrapidadvancement,theEmergingTechnologies,ResearchPrioritisationandSupport(EPS)unitwithinWHOhasstartedworkingon

neurotechnologyasakeyareathatwarrantsin-

depthexaminationofitsassociatedopportunities,gapsandrisks,especiallyfromaglobalhealth

perspective.Neurotechnologyisoneoftheareasinvestigatedforapplyingforesightapproaches

specificallyinordertoanticipate,optimizeand

accelerateitspositiveimpactforpopulations

whoneedit–particularlypopulationswhose

needsaretoofrequentlyneglected.Inadditiontoimprovingpreparednessandriskmanagement,thecontributionofthisprojectmayalsobeconsideredintermsofstrategyandpolicyplanning.ThroughtheworkofvariousteamsacrosstheOrganization

–notonlyEPSbutalsotheBrainHealthunit,theGlobalHealthEthicsandGovernanceunitandtheAgeingandHealthunit–WHOaimstounderstandandhighlightprogressinneurotechnology,andconsiderdevelopmentsinthisfieldinthecontextofefficacy,safety,accessibilityandriskfactors.

CHAPTER2

Objectivesandmethodology

2.1Objectives

Acrucialinitialstepindocumentingthe

developmentofneurotechnologyisalandscapeanalysiswherebytheextentandnatureofthe

progressofneurotechnologyisreviewedand

analysed.Theoverallaimofthelandscapeanalysisistoassesstheimpactofneurotechnology’s

progressonglobalhealthbyidentifyingcurrentopportunities,gapsandrisksacrossthefourselectedneurotechnologysubcategories.

2.2Landscapeanalysismethodology

Thelandscapeanalysiswasperformedinfive

stagesinaccordancewithWHO’sPerforminga

landscapeanalysis:understandinghealthproductresearchanddevelopment:aquickguide

(6)

,asdescribedbelow.

2.2.1Developingtheresearchquestion

Consideringthebroadapplicationand

developmentofneurotechnologyacrossmanyareas,thescopeoftheanalysiswasfocusedonthekeysubcategoriesthathavewitnessedrecentsignificantgrowth,particularlyinthenumberofclinicaltrialsthathaveutilizedsuchtechnologies(Fig.1),namely:

1.Neuroimaging

2.Brain-computerinterface(BCI)

3.Neuromodulation

4.Neurologicaldevices.

Figure1.Numberofclinicaltrialsassociatedwithneuroimaging,BCI,neuromodulationandneurologicaldevices,1999–2024

2500

2000

1500

1000

500

0

1999

2000

2001

2002

2003

2004

2005

2006

2007

2008

2009

2010

2011

2012

2013

2014

2015

2016

2017

2018

2019

2020

2021

2022

2023

2024

Total

Source:WorldHealthOrganizationInternationalClinicalTrialsRegistryPlatform(ICTRP)andWorldHealthOrganizationGlobalObservatoryonHealthResearchandDevelopment(GOHRD)

2

3

Foreachsubcategory,principalfactors

contributingtotheirprogressanddevelopmentwereanalysedasfollows:

1.Whatarethecurrentefficacyindicatorsandthe

latestdevelopmentsinhumanhealthconditionsineachsubcategoryofneurotechnology?

2.Whatarethelatestkeyfundingandinitiativeswithineachsubcategoryofneurotechnology?

3.Whatarethechallengesandconsiderationsfor

neurotechnologytranslationandimplementation,particularlyfromaglobalhealthperspective?

4.Whatarethesafetyindicationsandsafetyconcernsinneurotechnology?

5.Whatisthepotentialfordual-useof

neurotechnologyandhowisthiscurrentlybeingaddressedbyvariousstakeholders?

2.2.2Developingthemethod

Aliteraturereviewaggregatingneurotechnologydevelopmentwasperformedacrossseveral

electronicdatabases(Scopus,EBSCO,ProQuest

databases,Scopus,WebofScience).Thisincluded

bothresearchstudiesandreviews,aswellasotherrelevantdocumentsfromcommitteesandinitiativeswithintheareaofneurotechnology.Abroader

searchonneurotechnologydevelopment,includingthefourspecificsubcategories,wasconducted

first,followedbyamorefocusedsearchthat

targetedtheprincipalfactors,theirprogressandtheirdevelopment.

2.2.3Collectingthedata

Datasourceswerescreenedandreviewedaccordingtotheirrelevancetothescopeofthelandscape

analysis.Thesesourcesincludedefficacyindicators,fundingandinitiatives,accessibilityfactors,

safetyindicationsandconcerns,andthedual-usepotentialforeachofthefoursubcategoriesof

neurotechnology.Datasourcesfrom2019onwardswereprioritizedinordertoreflectthemostrecentadvancementsintheareaofneurotechnology.

Theevidenceshowedthatthepastfiveyears

weremarkedbyarapidgrowthinthenumberofpublicationsassociatedwithneurotechnology,thussuggestinggreaterresearcheffortsinits

development(Fig.2).

Figure2.Numberofpublicationsassociatedwithneurotechnology,2010–2023

Numberofassociatedpublications

800

600

400

200

0

2010

2011

2012

2013

2014

2015

2016

2017

2018

2019

2020

2021

2022

2023

Source:NationalInstitutesofHealth.Pubmed.Bethesda(Maryland):NationalLibraryofMedicine(USA),NationalCenterforBiotechnologyInformation(NCBI)

2.2.4Analysingandvisualizingtheresults

Therelevantinformationanddatarequiredwereextractedfromthevarioussourcesandincludedtheyearofpublication,relevantneurotechnologysubcategory,aims,methodology,resultsand

findings,aswellastheiroveralloutcomes.

2.2.5Disseminatingthefindings

Theanalyseddataandfindingsaresummarized

inthislandscapeanalysiswhichpresentsan

overviewofcurrentopportunities,risksandgapsinneurotechnologydevelopment,particularlyfromaglobalhealthperspective.

2.3Expertconsultation

On1October2024,WHOorganizedaglobal

consultationwith15expertsandkeystakeholdersinneurotechnology.Theconsultationinvolved

expertsrepresentingallsixWHOregionsand

importantconsiderationwasgiventoensuringagenderbalanceamongtheexperts.DeclarationsofinterestwerereceivedfromallexpertsandwereassessedbyWHO’ssecretariatwhichconcludedthattheinterestsoftheselectedpersonswould

notdetractfromthevalidityoftheconsultation.Allparticipantswereinformedofthedeclarationsofinterestatthestartoftheconsultation.

Duringtheconsultation,expertsontheselectedsubjectmatterfirstgaveshortpresentations

(so-called“l(fā)ightningtalks”)ondevelopment

inneuroimaging,BCI,neuromodulation,

neurologicaldevices,andtheoverallaccessibilityofneurotechnology.Inthesecondhalfof

theconsultation,participantsweredivided

intobreakoutroomstoaddressthedifferent

subcategoriesofneurotechnology.The

participantsthendiscussedvariousconsiderationsintheirneurotechnologysubcategory–mainly

thecurrentefficacyindications,accessibilityconsiderationsandsafetyfactors,including

theriskofdual-use.Thediscussionswerethencompiledandfurtherdiscussedbyallexperts.Asecondconsultationwasheldon5November2024withninesubjectmatterexpertsto

furtherdiscussthedual-usepotentialandotherconsiderationsofneurotechnology.Alldiscussionswereconsolidatedfrombothconsultations.Key

pointsandperspectivesofthedifferentexperts

weretakenintoconsiderationandsubstantiated

withrelevantpublicationsanddocumentsinordertoprovideaholisticanalysisoftheseideas.The

analysiswasthenincludedinthisreport.

2.4Limitationsoft