Guidelines
Safety,ethicalconsiderations,andapplicationguidelinesfortheuseof
transcranialmagneticstimulationinclinicalpracticeandresearchq
SimoneRossia,*,MarkHallettb,PaoloM.Rossinic,d,AlvaroPascual-Leoneeand
TheSafetyofTMSConsensusGroup1
aDipartimentodiNeuroscienze,SezioneNeurologia,UniversitàdiSiena,ItalybHumanMotorControlSection,NINDS,NIH,Bethesda,USAcUniversitàCampusBiomedico,Roma,ItalydCasadiCuraS.Raffaele,Cassino,ItalyeBerenson-AllenCenterforNoninvasiveBrainStimulation,BethIsraelDeaconessMedicalCenterandHarvardMedicalSchool,Boston,USA
articleinfo
Articlehistory:Accepted21August2009Availableonline14October2009
Keywords:TranscranialmagneticstimulationTMSrTMSSafetyabstract
Thisarticleisbasedonaconsensusconference,whichtookplaceinCertosadiPontignano,Siena(Italy)onMarch7–9,2008,intendedtoupdatetheprevioussafetyguidelinesfortheapplicationoftranscranialmagneticstimulation(TMS)inresearchandclinicalsettings.OverthepastdecadethescientificandmedicalcommunityhashadtheopportunitytoevaluatethesafetyrecordofresearchstudiesandclinicalapplicationsofTMSandrepetitiveTMS(rTMS).IntheseyearsthenumberofapplicationsofconventionalTMShasgrownimpressively,newparadigmsofstim-ulationhavebeendeveloped(e.g.,patternedrepetitiveTMS)andtechnicaladvanceshaveledtonewdevicedesignsandtothereal-timeintegrationofTMSwithelectroencephalography(EEG),positronemissiontomography(PET)andfunctionalmagneticresonanceimaging(fMRI).ThousandsofhealthysubjectsandpatientswithvariousneurologicalandpsychiatricdiseaseshaveundergoneTMSallowingabetterassessmentofrelativerisks.Theoccurrenceofseizures(i.e.,themostseriousTMS-relatedacuteadverseeffect)hasbeenextremelyrare,withmostofthefewnewcasesreceivingrTMSexceedingpre-viousguidelines,ofteninpatientsundertreatmentwithdrugswhichpotentiallylowertheseizurethreshold.ThepresentupdatedguidelinesreviewissuesofriskandsafetyofconventionalTMSprotocols,addresstheundesiredeffectsandrisksofemergingTMSinterventions,theapplicationsofTMSinpatientswith
1388-2457/$36.00Ó2009InternationalFederationofClinicalNeurophysiology.PublishedbyElsevierIrelandLtd.Allrightsreserved.doi:
10.1016/j.clinph.2009.08.016qAConsensusStatementfromtheInternationalWorkshopon‘‘PresentandFutureofTMS:SafetyandEthicalGuidelines”,Siena,March7–9,2008.*Correspondingauthor.Tel.:+390577585401;fax:+390577270260.E-mailaddress:rossisimo@unisi.it(S.Rossi).1GiulianoAvanzini,NeurocienzeCliniche,IstitutoNazionaleNeurologico‘‘C.Besta,Milano,Italy.SvenBestmann,SobellDepartmentofMotorNeuroscienceandMovementDisorders,UCLInstituteofNeurology,London,UK.AlfredoBerardelli,DepartmentofNeurologicalSciencesandNeuromedInstitute,UniversityofRome‘‘LaSapienza”,Roma,Italy.CarmenBrewer,NationalInstituteonDeafnessandotherCommunicationDisorders,NationalInstitutesofHealth,Bethesda,MD,USA.TurhanCanli,DepartmentofPsychology,StonyBrookUniversity,NewYork,USA.RobertoCantello,DipartimentodiMedicinaClinicaeSperimentale,SezioneNeurologia,UniversitàdelPiemonteOrientale‘‘A.Avogadro”,Novara,Italy.RobertChen,TorontoWesternResearchInstituteandDivisionofNeurology,DepartmentofMedicine,UniversityofToronto,Canada.JosephClassen,DepartmentofNeurology,UniversityofLeipzig,Germany.MarkDemitrack,Neuronetics,Inc.,Malvern,PA,USA.VincenzoDiLazzaro,InstituteofNeurology,UnivesitàCattolica,Roma,Italy.CharlesM.Epstein,DepartmentofNeurology,EmoryUniversitySchoolofMedicine,Atlanta,USA.MarkS.George,MedicalUniversityofSouthCarolina,Charleston,SC,USA.FelipeFregni,Berenson-AllenCenterforNoninvasiveBrainStimulation,BethIsrael.DeaconessMedicalCenter,HarvardMedicalSchool,Boston,MA,USA.RistoIlmoniemi,DepartmentBiomed.Eng.andComputationalScience(BECS),Helsinki,Finland.RezaJalinous,MagstimCompany,Boston,MA,USA.BarbaraKarp,CombinedNeuroScienceIRB,NationalInstitutesofHealth,Bethesda,MD,USA.Jean-PascalLefaucheur,ServicePhysiologie,ExplorationsFonctionnelles,HôpitalHenriMondor,Créteil,France.SarahLisanby,DivisionofBrainStimulation&TherapeuticModulation,ColumbiaUniversityCollegeofPhysiciansandSurgeons,NewYorkStatePsychiatricInstitute,NewYork,NY,USA.SabineMeunier,ServicedeRéadaptationFonctionnelle,HôpitaldelaSalpêtrière,Paris,France.CarloMiniussi,CognitiveNeuroscienceSection,IRCCSSanGiovannidiDioFatebenefratelli,Brescia,Italy.PedroMiranda,InstituteofBiophysicsandBiomedicalEngineering,FacultyofScience,UniversityofLisbon,Portugal.FrankPadberg,KlinikfürPsychiatrieundPsychotherapie,Ludwig-Maximilians-UniversitätMünchen,Germany.WalterPaulus,DepartmentofClinicalNeurophysiology,UniversityofGoettingen,Germany.AngelPeterchev,DivisionofBrainStimulationandTherapeuticModulation,DepartmentofPsychiatryandDepartmentofElectricalEngineering,ColumbiaUniversity,NewYork,NY,USA.CorinnaPorteri,BioethicsUnit,IRCCSSanGiovannidiDioFatebenefratelli,Brescia,Italy.MiriamProvost,MedicalDevicesBiologicsConsultingGroup,Inc.,Athens,GA,USA.AngeloQuartarone,DipartimentodiNeuroscienze,ScienzePsichiatricheedAnestesiologiche,UniversitàdiMessina,Italy.AlexanderRotenberg,DepartmentofNeurology,DivisionofEpilepsyandClinicalNeurophysiology,Children’sHospital,HarvardMedicalSchool,Boston,MA,USA.JohnRothwell,SobellDepartment,InstituteofNeurology,QueenSquare,London,UK.JarmoRuohonen,NexstimLtd.,Helsinki,Finland.HartwigSiebner,DanishResearchCentreforMagneticResonance,CopenhagenUniversityHospitalHvidovre,Denmark.GregorThut,CentreforCognitiveNeuroimaging,DepartmentofPsychology,UniversityofGlasgow,UK.JosepValls-Solè,NeurologyDepartment,HospitalClínic,UniversityofBarcelona,SpainVincentWalsh,InstituteofCognitiveNeuroscienceandDepartmentofPsychologyUniversityCollegeLondon,London,UK.YoshikatzuUgawa,DepartmentofNeurology,SchoolofMedicine,FukushimaMedicalUniversity,Japan.AbrahamZangen,DepartmentofNeurobiology,TheWeizmannInstituteofScience,Rehovot,Israel.UlfZiemann,KlinikumderJohannWolfgangGoethe-UniversitätFrankfurtamMain,
Germany.ClinicalNeurophysiology120(2009)2008–2039
ContentslistsavailableatScienceDirect
ClinicalNeurophysiology
journalhomepage:www.elsevier.com/locate/clinph
