Regulatory Considerations for the Clinical and Research Use of Transcranial Direct Current Stimulation (tDCS): review and recommendations from an expert panel
Identifieur interne : 003564 ( Main/Exploration ); précédent : 003563; suivant : 003565Regulatory Considerations for the Clinical and Research Use of Transcranial Direct Current Stimulation (tDCS): review and recommendations from an expert panel
Auteurs : F. Fregni [États-Unis] ; Ma Nitsche [Allemagne] ; C. K. Loo [Australie] ; Ar Brunoni [Brésil] ; P. Marangolo [Italie] ; J. Leite [États-Unis, Portugal] ; S. Carvalho [États-Unis, Portugal] ; N. Bolognini [Italie] ; W. Caumo ; Nj Paik [Corée du Sud] ; M. Simis [Brésil] ; K. Ueda [Japon] ; H. Ekhitari [Iran] ; P. Luu [États-Unis] ; Dm Tucker [États-Unis] ; Wj Tyler [États-Unis] ; J. Brunelin [France] ; A. Datta [États-Unis] ; Ch Juan [Taïwan] ; G. Venkatasubramanian [Inde] ; Ps Boggio [Brésil] ; M. Bikson [États-Unis]Source :
- Clinical research and regulatory affairs [ 1060-1333 ] ; 2014.
Abstract
The field of transcranial electrical stimulation (tES) has experienced significant growth in the past 15 years. One of the tES techniques leading this increased interest is transcranial direct current stimulation (tDCS). Significant research efforts have been devoted to determining the clinical potential of tDCS in humans. Despite the promising results obtained with tDCS in basic and clinical neuroscience, further progress has been impeded by a lack of clarity on international regulatory pathways. We therefore convened a group of research and clinician experts on tDCS to review the research and clinical use of tDCS. In this report, we review the regulatory status of tDCS, and we summarize the results according to research, off-label and compassionate use of tDCS in the following countries: Australia, Brazil, France, Germany, India, Iran, Italy, Portugal, South Korea, Taiwan and United States.
Research use, off label treatment and compassionate use of tDCS are employed in most of the countries reviewed in this study.
It is critical that a global or local effort is organized to pursue definite evidence to either approve and regulate or restrict the use of tDCS in clinical practice on the basis of adequate randomized controlled treatment trials.
Url:
DOI: 10.3109/10601333.2015.980944
PubMed: 25983531
PubMed Central: 4431691
Affiliations:
- Allemagne, Australie, Brésil, Corée du Sud, France, Inde, Iran, Italie, Japon, Portugal, Taïwan, États-Unis
- Basse-Saxe, Latium, Massachusetts, Nouvelle-Galles du Sud, Oregon, Région Nord (Portugal), Région capitale de Séoul, Virginie, État de New York, État de São Paulo
- Braga, Göttingen, Rome, Sydney, São Paulo, Séoul
- Université de São Paulo, Université du Minho
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Fregni</name><affiliation wicri:level="2"><nlm:aff id="A1">Spaulding Neuromodulation Center, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, Boston, MA</nlm:aff><country xml:lang="fr">États-Unis</country><placeName><region type="state">Massachusetts</region></placeName><wicri:cityArea>Spaulding Neuromodulation Center, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, Boston</wicri:cityArea></affiliation></author><author><name sortKey="Nitsche, Ma" sort="Nitsche, Ma" uniqKey="Nitsche M" first="Ma" last="Nitsche">Ma Nitsche</name><affiliation wicri:level="3"><nlm:aff id="A2">Department of Clinical Neurophysiology, Georg-August-University, Göttingen, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Clinical Neurophysiology, Georg-August-University, Göttingen</wicri:regionArea><placeName><region type="land" nuts="2">Basse-Saxe</region><settlement type="city">Göttingen</settlement></placeName></affiliation></author><author><name sortKey="Loo, C K" sort="Loo, C K" uniqKey="Loo C" first="C. 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Loo</name><affiliation wicri:level="3"><nlm:aff id="A3">School of Psychiatry & The Black Dog Institute, University of New South Wales, Sydney, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>School of Psychiatry & The Black Dog Institute, University of New South Wales, Sydney</wicri:regionArea><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName></affiliation></author><author><name sortKey="Brunoni, Ar" sort="Brunoni, Ar" uniqKey="Brunoni A" first="Ar" last="Brunoni">Ar Brunoni</name><affiliation wicri:level="4"><nlm:aff id="A4">Service of Interdisciplinary Neuromodulation, Department and Institute of Psychiatry, University of São Paulo, São Paulo, Brazil and Division of Neurology, Santa Casa Medicak School, Sao Paulo, Brazil</nlm:aff><country xml:lang="fr">Brésil</country><wicri:regionArea>Service of Interdisciplinary Neuromodulation, Department and Institute of Psychiatry, University of São Paulo, São Paulo, Brazil and Division of Neurology, Santa Casa Medicak School, Sao Paulo</wicri:regionArea><placeName><settlement type="city">São Paulo</settlement><region type="state">État de São Paulo</region><settlement type="city">São Paulo</settlement></placeName><orgName type="university">Université de São Paulo</orgName></affiliation></author><author><name sortKey="Marangolo, P" sort="Marangolo, P" uniqKey="Marangolo P" first="P" last="Marangolo">P. Marangolo</name><affiliation wicri:level="3"><nlm:aff id="A5">Department of Experimental and Clinical Medicine, University Politecnica delle Marche, Ancona, and IRCCS Fondazione Santa Lucia, Roma, Italy</nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea>Department of Experimental and Clinical Medicine, University Politecnica delle Marche, Ancona, and IRCCS Fondazione Santa Lucia, Roma</wicri:regionArea><placeName><settlement type="city">Rome</settlement><region nuts="2">Latium</region></placeName></affiliation></author><author><name sortKey="Leite, J" sort="Leite, J" uniqKey="Leite J" first="J" last="Leite">J. Leite</name><affiliation wicri:level="2"><nlm:aff id="A1">Spaulding Neuromodulation Center, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, Boston, MA</nlm:aff><country xml:lang="fr">États-Unis</country><placeName><region type="state">Massachusetts</region></placeName><wicri:cityArea>Spaulding Neuromodulation Center, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, Boston</wicri:cityArea></affiliation><affiliation wicri:level="4"><nlm:aff id="A6">Neuropsychophysiology Laboratory, CIPsi, School of Psychology (EPsi), University of Minho, Campus de Gualtar, Braga, Portugal</nlm:aff><country xml:lang="fr">Portugal</country><wicri:regionArea>Neuropsychophysiology Laboratory, CIPsi, School of Psychology (EPsi), University of Minho, Campus de Gualtar, Braga</wicri:regionArea><orgName type="university">Université du Minho</orgName><placeName><settlement type="city">Braga</settlement><region>Région Nord (Portugal)</region></placeName></affiliation></author><author><name sortKey="Carvalho, S" sort="Carvalho, S" uniqKey="Carvalho S" first="S" last="Carvalho">S. Carvalho</name><affiliation wicri:level="2"><nlm:aff id="A1">Spaulding Neuromodulation Center, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, Boston, MA</nlm:aff><country xml:lang="fr">États-Unis</country><placeName><region type="state">Massachusetts</region></placeName><wicri:cityArea>Spaulding Neuromodulation Center, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, Boston</wicri:cityArea></affiliation><affiliation wicri:level="4"><nlm:aff id="A6">Neuropsychophysiology Laboratory, CIPsi, School of Psychology (EPsi), University of Minho, Campus de Gualtar, Braga, Portugal</nlm:aff><country xml:lang="fr">Portugal</country><wicri:regionArea>Neuropsychophysiology Laboratory, CIPsi, School of Psychology (EPsi), University of Minho, Campus de Gualtar, Braga</wicri:regionArea><orgName type="university">Université du Minho</orgName><placeName><settlement type="city">Braga</settlement><region>Région Nord (Portugal)</region></placeName></affiliation></author><author><name sortKey="Bolognini, N" sort="Bolognini, N" uniqKey="Bolognini N" first="N" last="Bolognini">N. Bolognini</name><affiliation wicri:level="1"><nlm:aff id="A7">Department of Psychology, University of Milano Bicocca, and Laboratory of Neuropsychology, IRCC Instituto Auxologico Italiano, Milano, Italy</nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea>Department of Psychology, University of Milano Bicocca, and Laboratory of Neuropsychology, IRCC Instituto Auxologico Italiano, Milano</wicri:regionArea><wicri:noRegion>Milano</wicri:noRegion></affiliation></author><author><name sortKey="Caumo, W" sort="Caumo, W" uniqKey="Caumo W" first="W" last="Caumo">W. Caumo</name><affiliation><nlm:aff id="A8">Laboratory of Pain & Neuromodulation at Hospital de Clínicas de Porto Alegre at UFRGS</nlm:aff></affiliation></author><author><name sortKey="Paik, Nj" sort="Paik, Nj" uniqKey="Paik N" first="Nj" last="Paik">Nj Paik</name><affiliation wicri:level="3"><nlm:aff id="A9">Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seoul, South Korea</nlm:aff><country xml:lang="fr">Corée du Sud</country><wicri:regionArea>Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seoul</wicri:regionArea><placeName><settlement type="city">Séoul</settlement><region type="capital">Région capitale de Séoul</region></placeName></affiliation></author><author><name sortKey="Simis, M" sort="Simis, M" uniqKey="Simis M" first="M" last="Simis">M. Simis</name><affiliation wicri:level="4"><nlm:aff id="A4">Service of Interdisciplinary Neuromodulation, Department and Institute of Psychiatry, University of São Paulo, São Paulo, Brazil and Division of Neurology, Santa Casa Medicak School, Sao Paulo, Brazil</nlm:aff><country xml:lang="fr">Brésil</country><wicri:regionArea>Service of Interdisciplinary Neuromodulation, Department and Institute of Psychiatry, University of São Paulo, São Paulo, Brazil and Division of Neurology, Santa Casa Medicak School, Sao Paulo</wicri:regionArea><placeName><settlement type="city">São Paulo</settlement><region type="state">État de São Paulo</region><settlement type="city">São Paulo</settlement></placeName><orgName type="university">Université de São Paulo</orgName></affiliation></author><author><name sortKey="Ueda, K" sort="Ueda, K" uniqKey="Ueda K" first="K" last="Ueda">K. Ueda</name><affiliation wicri:level="1"><nlm:aff id="A10">National Cardiovascular Center, Osaka, Japan</nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea>National Cardiovascular Center, Osaka</wicri:regionArea><wicri:noRegion>Osaka</wicri:noRegion></affiliation></author><author><name sortKey="Ekhitari, H" sort="Ekhitari, H" uniqKey="Ekhitari H" first="H" last="Ekhitari">H. Ekhitari</name><affiliation wicri:level="1"><nlm:aff id="A11">Translational Neuroscience Program, Institute for Cognitive Science Studies, Tehran, Iran</nlm:aff><country xml:lang="fr">Iran</country><wicri:regionArea>Translational Neuroscience Program, Institute for Cognitive Science Studies, Tehran</wicri:regionArea><wicri:noRegion>Tehran</wicri:noRegion></affiliation><affiliation wicri:level="1"><nlm:aff id="A12">Neurocognitive Laboratory, Iranian National Center for Addiction Studies, Tehran University of Medical Sciences, Tehran, Iran</nlm:aff><country xml:lang="fr">Iran</country><wicri:regionArea>Neurocognitive Laboratory, Iranian National Center for Addiction Studies, Tehran University of Medical Sciences, Tehran</wicri:regionArea><wicri:noRegion>Tehran</wicri:noRegion></affiliation></author><author><name sortKey="Luu, P" sort="Luu, P" uniqKey="Luu P" first="P" last="Luu">P. Luu</name><affiliation wicri:level="2"><nlm:aff id="A13">Electrical Geodesics, Inc., and University of Oregon, Eugene, Oregon, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Electrical Geodesics, Inc., and University of Oregon, Eugene, Oregon</wicri:regionArea><placeName><region type="state">Oregon</region></placeName></affiliation></author><author><name sortKey="Tucker, Dm" sort="Tucker, Dm" uniqKey="Tucker D" first="Dm" last="Tucker">Dm Tucker</name><affiliation wicri:level="2"><nlm:aff id="A13">Electrical Geodesics, Inc., and University of Oregon, Eugene, Oregon, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Electrical Geodesics, Inc., and University of Oregon, Eugene, Oregon</wicri:regionArea><placeName><region type="state">Oregon</region></placeName></affiliation></author><author><name sortKey="Tyler, Wj" sort="Tyler, Wj" uniqKey="Tyler W" first="Wj" last="Tyler">Wj Tyler</name><affiliation wicri:level="2"><nlm:aff id="A14">Virginia Tech Carilion Research Institute, Department of Psychiatry and Behavioral Medicine, Virginia Tech Carilion School of Medicine, and School of Biomedical Engineering and Sciences, Virginia Tech, Roanoke, VA USA</nlm:aff><country>États-Unis</country><placeName><region type="state">Virginie</region></placeName><wicri:cityArea>Virginia Tech Carilion Research Institute, Department of Psychiatry and Behavioral Medicine, Virginia Tech Carilion School of Medicine, and School of Biomedical Engineering and Sciences, Virginia Tech, Roanoke</wicri:cityArea></affiliation></author><author><name sortKey="Brunelin, J" sort="Brunelin, J" uniqKey="Brunelin J" first="J" last="Brunelin">J. Brunelin</name><affiliation wicri:level="1"><nlm:aff id="A15">EA 4615, Centre Hospitalier le Vinatier, Université de Lyon, F-69003, Université Claude Bernard Lyon I, Bron, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>EA 4615, Centre Hospitalier le Vinatier, Université de Lyon, F-69003, Université Claude Bernard Lyon I, Bron</wicri:regionArea><wicri:noRegion>Bron</wicri:noRegion><wicri:noRegion>Bron</wicri:noRegion></affiliation></author><author><name sortKey="Datta, A" sort="Datta, A" uniqKey="Datta A" first="A" last="Datta">A. Datta</name><affiliation wicri:level="2"><nlm:aff id="A16">Department of Biomedical Engineering, Neural Engineering Laboratory, The City College of the City University of New York New York, NY, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Biomedical Engineering, Neural Engineering Laboratory, The City College of the City University of New York New York, NY</wicri:regionArea><placeName><region type="state">État de New York</region></placeName></affiliation></author><author><name sortKey="Juan, Ch" sort="Juan, Ch" uniqKey="Juan C" first="Ch" last="Juan">Ch Juan</name><affiliation wicri:level="1"><nlm:aff id="A17">Institute of Cognitive Neuroscience, National Central University, Taiwan</nlm:aff><country xml:lang="fr">Taïwan</country><wicri:regionArea>Institute of Cognitive Neuroscience, National Central University</wicri:regionArea><wicri:noRegion>National Central University</wicri:noRegion></affiliation></author><author><name sortKey="Venkatasubramanian, G" sort="Venkatasubramanian, G" uniqKey="Venkatasubramanian G" first="G" last="Venkatasubramanian">G. Venkatasubramanian</name><affiliation wicri:level="1"><nlm:aff id="A18">Translational Psychiatry Laboratory, Department of Psychiatry, National Institute of Mental Health and Neurosciences, Bangalore, India</nlm:aff><country xml:lang="fr">Inde</country><wicri:regionArea>Translational Psychiatry Laboratory, Department of Psychiatry, National Institute of Mental Health and Neurosciences, Bangalore</wicri:regionArea><wicri:noRegion>Bangalore</wicri:noRegion></affiliation></author><author><name sortKey="Boggio, Ps" sort="Boggio, Ps" uniqKey="Boggio P" first="Ps" last="Boggio">Ps Boggio</name><affiliation wicri:level="3"><nlm:aff id="A19">Social and Cognitive Neuroscience Laboratory and Developmental Disorders Program, Center for Healthy and Biological Sciences, Mackenzie Presbyterian University, Sao Paulo, Brazil</nlm:aff><country xml:lang="fr">Brésil</country><wicri:regionArea>Social and Cognitive Neuroscience Laboratory and Developmental Disorders Program, Center for Healthy and Biological Sciences, Mackenzie Presbyterian University, Sao Paulo</wicri:regionArea><placeName><settlement type="city">São Paulo</settlement><region type="state">État de São Paulo</region></placeName></affiliation></author><author><name sortKey="Bikson, M" sort="Bikson, M" uniqKey="Bikson M" first="M" last="Bikson">M. Bikson</name><affiliation wicri:level="2"><nlm:aff id="A16">Department of Biomedical Engineering, Neural Engineering Laboratory, The City College of the City University of New York New York, NY, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Biomedical Engineering, Neural Engineering Laboratory, The City College of the City University of New York New York, NY</wicri:regionArea><placeName><region type="state">État de New York</region></placeName></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">25983531</idno><idno type="pmc">4431691</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4431691</idno><idno type="RBID">PMC:4431691</idno><idno type="doi">10.3109/10601333.2015.980944</idno><date when="2014">2014</date><idno type="wicri:Area/Pmc/Corpus">002105</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">002105</idno><idno type="wicri:Area/Pmc/Curation">001F59</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">001F59</idno><idno type="wicri:Area/Pmc/Checkpoint">001372</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Checkpoint">001372</idno><idno type="wicri:source">PubMed</idno><idno type="wicri:Area/PubMed/Corpus">002F05</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">002F05</idno><idno type="wicri:Area/PubMed/Curation">002E27</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Curation">002E27</idno><idno type="wicri:Area/PubMed/Checkpoint">002E27</idno><idno type="wicri:explorRef" wicri:stream="Checkpoint" wicri:step="PubMed">002E27</idno><idno type="wicri:Area/Ncbi/Merge">002581</idno><idno type="wicri:Area/Ncbi/Curation">002581</idno><idno type="wicri:Area/Ncbi/Checkpoint">002581</idno><idno type="wicri:doubleKey">1060-1333:2014:Fregni F:regulatory:considerations:for</idno><idno type="wicri:Area/Main/Merge">003581</idno><idno type="wicri:Area/Main/Curation">003564</idno><idno type="wicri:Area/Main/Exploration">003564</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Regulatory Considerations for the Clinical and Research Use of Transcranial Direct Current Stimulation (tDCS): review and recommendations from an expert panel</title><author><name sortKey="Fregni, F" sort="Fregni, F" uniqKey="Fregni F" first="F" last="Fregni">F. Fregni</name><affiliation wicri:level="2"><nlm:aff id="A1">Spaulding Neuromodulation Center, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, Boston, MA</nlm:aff><country xml:lang="fr">États-Unis</country><placeName><region type="state">Massachusetts</region></placeName><wicri:cityArea>Spaulding Neuromodulation Center, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, Boston</wicri:cityArea></affiliation></author><author><name sortKey="Nitsche, Ma" sort="Nitsche, Ma" uniqKey="Nitsche M" first="Ma" last="Nitsche">Ma Nitsche</name><affiliation wicri:level="3"><nlm:aff id="A2">Department of Clinical Neurophysiology, Georg-August-University, Göttingen, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Clinical Neurophysiology, Georg-August-University, Göttingen</wicri:regionArea><placeName><region type="land" nuts="2">Basse-Saxe</region><settlement type="city">Göttingen</settlement></placeName></affiliation></author><author><name sortKey="Loo, C K" sort="Loo, C K" uniqKey="Loo C" first="C. K." last="Loo">C. K. Loo</name><affiliation wicri:level="3"><nlm:aff id="A3">School of Psychiatry & The Black Dog Institute, University of New South Wales, Sydney, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>School of Psychiatry & The Black Dog Institute, University of New South Wales, Sydney</wicri:regionArea><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName></affiliation></author><author><name sortKey="Brunoni, Ar" sort="Brunoni, Ar" uniqKey="Brunoni A" first="Ar" last="Brunoni">Ar Brunoni</name><affiliation wicri:level="4"><nlm:aff id="A4">Service of Interdisciplinary Neuromodulation, Department and Institute of Psychiatry, University of São Paulo, São Paulo, Brazil and Division of Neurology, Santa Casa Medicak School, Sao Paulo, Brazil</nlm:aff><country xml:lang="fr">Brésil</country><wicri:regionArea>Service of Interdisciplinary Neuromodulation, Department and Institute of Psychiatry, University of São Paulo, São Paulo, Brazil and Division of Neurology, Santa Casa Medicak School, Sao Paulo</wicri:regionArea><placeName><settlement type="city">São Paulo</settlement><region type="state">État de São Paulo</region><settlement type="city">São Paulo</settlement></placeName><orgName type="university">Université de São Paulo</orgName></affiliation></author><author><name sortKey="Marangolo, P" sort="Marangolo, P" uniqKey="Marangolo P" first="P" last="Marangolo">P. Marangolo</name><affiliation wicri:level="3"><nlm:aff id="A5">Department of Experimental and Clinical Medicine, University Politecnica delle Marche, Ancona, and IRCCS Fondazione Santa Lucia, Roma, Italy</nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea>Department of Experimental and Clinical Medicine, University Politecnica delle Marche, Ancona, and IRCCS Fondazione Santa Lucia, Roma</wicri:regionArea><placeName><settlement type="city">Rome</settlement><region nuts="2">Latium</region></placeName></affiliation></author><author><name sortKey="Leite, J" sort="Leite, J" uniqKey="Leite J" first="J" last="Leite">J. Leite</name><affiliation wicri:level="2"><nlm:aff id="A1">Spaulding Neuromodulation Center, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, Boston, MA</nlm:aff><country xml:lang="fr">États-Unis</country><placeName><region type="state">Massachusetts</region></placeName><wicri:cityArea>Spaulding Neuromodulation Center, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, Boston</wicri:cityArea></affiliation><affiliation wicri:level="4"><nlm:aff id="A6">Neuropsychophysiology Laboratory, CIPsi, School of Psychology (EPsi), University of Minho, Campus de Gualtar, Braga, Portugal</nlm:aff><country xml:lang="fr">Portugal</country><wicri:regionArea>Neuropsychophysiology Laboratory, CIPsi, School of Psychology (EPsi), University of Minho, Campus de Gualtar, Braga</wicri:regionArea><orgName type="university">Université du Minho</orgName><placeName><settlement type="city">Braga</settlement><region>Région Nord (Portugal)</region></placeName></affiliation></author><author><name sortKey="Carvalho, S" sort="Carvalho, S" uniqKey="Carvalho S" first="S" last="Carvalho">S. Carvalho</name><affiliation wicri:level="2"><nlm:aff id="A1">Spaulding Neuromodulation Center, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, Boston, MA</nlm:aff><country xml:lang="fr">États-Unis</country><placeName><region type="state">Massachusetts</region></placeName><wicri:cityArea>Spaulding Neuromodulation Center, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, Boston</wicri:cityArea></affiliation><affiliation wicri:level="4"><nlm:aff id="A6">Neuropsychophysiology Laboratory, CIPsi, School of Psychology (EPsi), University of Minho, Campus de Gualtar, Braga, Portugal</nlm:aff><country xml:lang="fr">Portugal</country><wicri:regionArea>Neuropsychophysiology Laboratory, CIPsi, School of Psychology (EPsi), University of Minho, Campus de Gualtar, Braga</wicri:regionArea><orgName type="university">Université du Minho</orgName><placeName><settlement type="city">Braga</settlement><region>Région Nord (Portugal)</region></placeName></affiliation></author><author><name sortKey="Bolognini, N" sort="Bolognini, N" uniqKey="Bolognini N" first="N" last="Bolognini">N. Bolognini</name><affiliation wicri:level="1"><nlm:aff id="A7">Department of Psychology, University of Milano Bicocca, and Laboratory of Neuropsychology, IRCC Instituto Auxologico Italiano, Milano, Italy</nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea>Department of Psychology, University of Milano Bicocca, and Laboratory of Neuropsychology, IRCC Instituto Auxologico Italiano, Milano</wicri:regionArea><wicri:noRegion>Milano</wicri:noRegion></affiliation></author><author><name sortKey="Caumo, W" sort="Caumo, W" uniqKey="Caumo W" first="W" last="Caumo">W. Caumo</name><affiliation><nlm:aff id="A8">Laboratory of Pain & Neuromodulation at Hospital de Clínicas de Porto Alegre at UFRGS</nlm:aff></affiliation></author><author><name sortKey="Paik, Nj" sort="Paik, Nj" uniqKey="Paik N" first="Nj" last="Paik">Nj Paik</name><affiliation wicri:level="3"><nlm:aff id="A9">Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seoul, South Korea</nlm:aff><country xml:lang="fr">Corée du Sud</country><wicri:regionArea>Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seoul</wicri:regionArea><placeName><settlement type="city">Séoul</settlement><region type="capital">Région capitale de Séoul</region></placeName></affiliation></author><author><name sortKey="Simis, M" sort="Simis, M" uniqKey="Simis M" first="M" last="Simis">M. Simis</name><affiliation wicri:level="4"><nlm:aff id="A4">Service of Interdisciplinary Neuromodulation, Department and Institute of Psychiatry, University of São Paulo, São Paulo, Brazil and Division of Neurology, Santa Casa Medicak School, Sao Paulo, Brazil</nlm:aff><country xml:lang="fr">Brésil</country><wicri:regionArea>Service of Interdisciplinary Neuromodulation, Department and Institute of Psychiatry, University of São Paulo, São Paulo, Brazil and Division of Neurology, Santa Casa Medicak School, Sao Paulo</wicri:regionArea><placeName><settlement type="city">São Paulo</settlement><region type="state">État de São Paulo</region><settlement type="city">São Paulo</settlement></placeName><orgName type="university">Université de São Paulo</orgName></affiliation></author><author><name sortKey="Ueda, K" sort="Ueda, K" uniqKey="Ueda K" first="K" last="Ueda">K. Ueda</name><affiliation wicri:level="1"><nlm:aff id="A10">National Cardiovascular Center, Osaka, Japan</nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea>National Cardiovascular Center, Osaka</wicri:regionArea><wicri:noRegion>Osaka</wicri:noRegion></affiliation></author><author><name sortKey="Ekhitari, H" sort="Ekhitari, H" uniqKey="Ekhitari H" first="H" last="Ekhitari">H. Ekhitari</name><affiliation wicri:level="1"><nlm:aff id="A11">Translational Neuroscience Program, Institute for Cognitive Science Studies, Tehran, Iran</nlm:aff><country xml:lang="fr">Iran</country><wicri:regionArea>Translational Neuroscience Program, Institute for Cognitive Science Studies, Tehran</wicri:regionArea><wicri:noRegion>Tehran</wicri:noRegion></affiliation><affiliation wicri:level="1"><nlm:aff id="A12">Neurocognitive Laboratory, Iranian National Center for Addiction Studies, Tehran University of Medical Sciences, Tehran, Iran</nlm:aff><country xml:lang="fr">Iran</country><wicri:regionArea>Neurocognitive Laboratory, Iranian National Center for Addiction Studies, Tehran University of Medical Sciences, Tehran</wicri:regionArea><wicri:noRegion>Tehran</wicri:noRegion></affiliation></author><author><name sortKey="Luu, P" sort="Luu, P" uniqKey="Luu P" first="P" last="Luu">P. Luu</name><affiliation wicri:level="2"><nlm:aff id="A13">Electrical Geodesics, Inc., and University of Oregon, Eugene, Oregon, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Electrical Geodesics, Inc., and University of Oregon, Eugene, Oregon</wicri:regionArea><placeName><region type="state">Oregon</region></placeName></affiliation></author><author><name sortKey="Tucker, Dm" sort="Tucker, Dm" uniqKey="Tucker D" first="Dm" last="Tucker">Dm Tucker</name><affiliation wicri:level="2"><nlm:aff id="A13">Electrical Geodesics, Inc., and University of Oregon, Eugene, Oregon, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Electrical Geodesics, Inc., and University of Oregon, Eugene, Oregon</wicri:regionArea><placeName><region type="state">Oregon</region></placeName></affiliation></author><author><name sortKey="Tyler, Wj" sort="Tyler, Wj" uniqKey="Tyler W" first="Wj" last="Tyler">Wj Tyler</name><affiliation wicri:level="2"><nlm:aff id="A14">Virginia Tech Carilion Research Institute, Department of Psychiatry and Behavioral Medicine, Virginia Tech Carilion School of Medicine, and School of Biomedical Engineering and Sciences, Virginia Tech, Roanoke, VA USA</nlm:aff><country>États-Unis</country><placeName><region type="state">Virginie</region></placeName><wicri:cityArea>Virginia Tech Carilion Research Institute, Department of Psychiatry and Behavioral Medicine, Virginia Tech Carilion School of Medicine, and School of Biomedical Engineering and Sciences, Virginia Tech, Roanoke</wicri:cityArea></affiliation></author><author><name sortKey="Brunelin, J" sort="Brunelin, J" uniqKey="Brunelin J" first="J" last="Brunelin">J. Brunelin</name><affiliation wicri:level="1"><nlm:aff id="A15">EA 4615, Centre Hospitalier le Vinatier, Université de Lyon, F-69003, Université Claude Bernard Lyon I, Bron, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>EA 4615, Centre Hospitalier le Vinatier, Université de Lyon, F-69003, Université Claude Bernard Lyon I, Bron</wicri:regionArea><wicri:noRegion>Bron</wicri:noRegion><wicri:noRegion>Bron</wicri:noRegion></affiliation></author><author><name sortKey="Datta, A" sort="Datta, A" uniqKey="Datta A" first="A" last="Datta">A. Datta</name><affiliation wicri:level="2"><nlm:aff id="A16">Department of Biomedical Engineering, Neural Engineering Laboratory, The City College of the City University of New York New York, NY, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Biomedical Engineering, Neural Engineering Laboratory, The City College of the City University of New York New York, NY</wicri:regionArea><placeName><region type="state">État de New York</region></placeName></affiliation></author><author><name sortKey="Juan, Ch" sort="Juan, Ch" uniqKey="Juan C" first="Ch" last="Juan">Ch Juan</name><affiliation wicri:level="1"><nlm:aff id="A17">Institute of Cognitive Neuroscience, National Central University, Taiwan</nlm:aff><country xml:lang="fr">Taïwan</country><wicri:regionArea>Institute of Cognitive Neuroscience, National Central University</wicri:regionArea><wicri:noRegion>National Central University</wicri:noRegion></affiliation></author><author><name sortKey="Venkatasubramanian, G" sort="Venkatasubramanian, G" uniqKey="Venkatasubramanian G" first="G" last="Venkatasubramanian">G. Venkatasubramanian</name><affiliation wicri:level="1"><nlm:aff id="A18">Translational Psychiatry Laboratory, Department of Psychiatry, National Institute of Mental Health and Neurosciences, Bangalore, India</nlm:aff><country xml:lang="fr">Inde</country><wicri:regionArea>Translational Psychiatry Laboratory, Department of Psychiatry, National Institute of Mental Health and Neurosciences, Bangalore</wicri:regionArea><wicri:noRegion>Bangalore</wicri:noRegion></affiliation></author><author><name sortKey="Boggio, Ps" sort="Boggio, Ps" uniqKey="Boggio P" first="Ps" last="Boggio">Ps Boggio</name><affiliation wicri:level="3"><nlm:aff id="A19">Social and Cognitive Neuroscience Laboratory and Developmental Disorders Program, Center for Healthy and Biological Sciences, Mackenzie Presbyterian University, Sao Paulo, Brazil</nlm:aff><country xml:lang="fr">Brésil</country><wicri:regionArea>Social and Cognitive Neuroscience Laboratory and Developmental Disorders Program, Center for Healthy and Biological Sciences, Mackenzie Presbyterian University, Sao Paulo</wicri:regionArea><placeName><settlement type="city">São Paulo</settlement><region type="state">État de São Paulo</region></placeName></affiliation></author><author><name sortKey="Bikson, M" sort="Bikson, M" uniqKey="Bikson M" first="M" last="Bikson">M. Bikson</name><affiliation wicri:level="2"><nlm:aff id="A16">Department of Biomedical Engineering, Neural Engineering Laboratory, The City College of the City University of New York New York, NY, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Biomedical Engineering, Neural Engineering Laboratory, The City College of the City University of New York New York, NY</wicri:regionArea><placeName><region type="state">État de New York</region></placeName></affiliation></author></analytic><series><title level="j">Clinical research and regulatory affairs</title><idno type="ISSN">1060-1333</idno><idno type="eISSN">1532-2521</idno><imprint><date when="2014">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p id="P1">The field of transcranial electrical stimulation (tES) has experienced significant growth in the past 15 years. One of the tES techniques leading this increased interest is transcranial direct current stimulation (tDCS). Significant research efforts have been devoted to determining the clinical potential of tDCS in humans. Despite the promising results obtained with tDCS in basic and clinical neuroscience, further progress has been impeded by a lack of clarity on international regulatory pathways. We therefore convened a group of research and clinician experts on tDCS to review the research and clinical use of tDCS. In this report, we review the regulatory status of tDCS, and we summarize the results according to research, off-label and compassionate use of tDCS in the following countries: Australia, Brazil, France, Germany, India, Iran, Italy, Portugal, South Korea, Taiwan and United States.</p><p id="P2">Research use, off label treatment and compassionate use of tDCS are employed in most of the countries reviewed in this study.</p><p id="P3">It is critical that a global or local effort is organized to pursue definite evidence to either approve and regulate or restrict the use of tDCS in clinical practice on the basis of adequate randomized controlled treatment trials.</p></div></front></TEI><affiliations><list><country><li>Allemagne</li><li>Australie</li><li>Brésil</li><li>Corée du Sud</li><li>France</li><li>Inde</li><li>Iran</li><li>Italie</li><li>Japon</li><li>Portugal</li><li>Taïwan</li><li>États-Unis</li></country><region><li>Basse-Saxe</li><li>Latium</li><li>Massachusetts</li><li>Nouvelle-Galles du Sud</li><li>Oregon</li><li>Région Nord (Portugal)</li><li>Région capitale de Séoul</li><li>Virginie</li><li>État de New York</li><li>État de São Paulo</li></region><settlement><li>Braga</li><li>Göttingen</li><li>Rome</li><li>Sydney</li><li>São Paulo</li><li>Séoul</li></settlement><orgName><li>Université de São Paulo</li><li>Université du Minho</li></orgName></list><tree><noCountry><name sortKey="Caumo, W" sort="Caumo, W" uniqKey="Caumo W" first="W" last="Caumo">W. Caumo</name></noCountry><country name="États-Unis"><region name="Massachusetts"><name sortKey="Fregni, F" sort="Fregni, F" uniqKey="Fregni F" first="F" last="Fregni">F. Fregni</name></region><name sortKey="Bikson, M" sort="Bikson, M" uniqKey="Bikson M" first="M" last="Bikson">M. Bikson</name><name sortKey="Carvalho, S" sort="Carvalho, S" uniqKey="Carvalho S" first="S" last="Carvalho">S. Carvalho</name><name sortKey="Datta, A" sort="Datta, A" uniqKey="Datta A" first="A" last="Datta">A. Datta</name><name sortKey="Leite, J" sort="Leite, J" uniqKey="Leite J" first="J" last="Leite">J. Leite</name><name sortKey="Luu, P" sort="Luu, P" uniqKey="Luu P" first="P" last="Luu">P. Luu</name><name sortKey="Tucker, Dm" sort="Tucker, Dm" uniqKey="Tucker D" first="Dm" last="Tucker">Dm Tucker</name><name sortKey="Tyler, Wj" sort="Tyler, Wj" uniqKey="Tyler W" first="Wj" last="Tyler">Wj Tyler</name></country><country name="Allemagne"><region name="Basse-Saxe"><name sortKey="Nitsche, Ma" sort="Nitsche, Ma" uniqKey="Nitsche M" first="Ma" last="Nitsche">Ma Nitsche</name></region></country><country name="Australie"><region name="Nouvelle-Galles du Sud"><name sortKey="Loo, C K" sort="Loo, C K" uniqKey="Loo C" first="C. K." last="Loo">C. K. Loo</name></region></country><country name="Brésil"><region name="État de São Paulo"><name sortKey="Brunoni, Ar" sort="Brunoni, Ar" uniqKey="Brunoni A" first="Ar" last="Brunoni">Ar Brunoni</name></region><name sortKey="Boggio, Ps" sort="Boggio, Ps" uniqKey="Boggio P" first="Ps" last="Boggio">Ps Boggio</name><name sortKey="Simis, M" sort="Simis, M" uniqKey="Simis M" first="M" last="Simis">M. Simis</name></country><country name="Italie"><region name="Latium"><name sortKey="Marangolo, P" sort="Marangolo, P" uniqKey="Marangolo P" first="P" last="Marangolo">P. Marangolo</name></region><name sortKey="Bolognini, N" sort="Bolognini, N" uniqKey="Bolognini N" first="N" last="Bolognini">N. Bolognini</name></country><country name="Portugal"><region name="Région Nord (Portugal)"><name sortKey="Leite, J" sort="Leite, J" uniqKey="Leite J" first="J" last="Leite">J. Leite</name></region><name sortKey="Carvalho, S" sort="Carvalho, S" uniqKey="Carvalho S" first="S" last="Carvalho">S. Carvalho</name></country><country name="Corée du Sud"><region name="Région capitale de Séoul"><name sortKey="Paik, Nj" sort="Paik, Nj" uniqKey="Paik N" first="Nj" last="Paik">Nj Paik</name></region></country><country name="Japon"><noRegion><name sortKey="Ueda, K" sort="Ueda, K" uniqKey="Ueda K" first="K" last="Ueda">K. Ueda</name></noRegion></country><country name="Iran"><noRegion><name sortKey="Ekhitari, H" sort="Ekhitari, H" uniqKey="Ekhitari H" first="H" last="Ekhitari">H. Ekhitari</name></noRegion><name sortKey="Ekhitari, H" sort="Ekhitari, H" uniqKey="Ekhitari H" first="H" last="Ekhitari">H. Ekhitari</name></country><country name="France"><noRegion><name sortKey="Brunelin, J" sort="Brunelin, J" uniqKey="Brunelin J" first="J" last="Brunelin">J. Brunelin</name></noRegion></country><country name="Taïwan"><noRegion><name sortKey="Juan, Ch" sort="Juan, Ch" uniqKey="Juan C" first="Ch" last="Juan">Ch Juan</name></noRegion></country><country name="Inde"><noRegion><name sortKey="Venkatasubramanian, G" sort="Venkatasubramanian, G" uniqKey="Venkatasubramanian G" first="G" last="Venkatasubramanian">G. Venkatasubramanian</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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