Publicação
Regulatory considerations for the clinical and research use of transcranial Direct Current Stimulation (tDCS): Review and recommendations from an expert panel
| Resumo: | 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. Therefore, a group of research and clinician experts on tDCS were convened to review the research and clinical use of tDCS. This report reviews the regulatory status of tDCS and summarizes 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 the US. 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. |
|---|---|
| Autores principais: | Fregni, F. |
| Outros Autores: | Nitsche, M. A.; Loo, C. K.; Brunoni, A. R.; Marangolo, P.; Leite, Jorge; Carvalho, Sandra; Bolognini, N.; Caumo, W.; Paik, N. J.; Simis, M.; Ueda, K.; Ekhtiari, H.; Luu, P.; Tucker, D. M.; Tyler, W. J.; Brunelin, J.; Datta, A.; Juan, C. H.; Venkatasubramanian, G.; Boggio, P. S.; Bikson, M. |
| Assunto: | Regulatory Safety TDCS Ciências Sociais::Psicologia |
| Ano: | 2015 |
| País: | Portugal |
| Tipo de documento: | artigo |
| Tipo de acesso: | acesso aberto |
| Instituição associada: | Universidade do Minho |
| Idioma: | inglês |
| Origem: | RepositóriUM - Universidade do Minho |
| _version_ | 1867439159360094208 |
|---|---|
| author | Fregni, F. |
| author2 | Nitsche, M. A. Loo, C. K. Brunoni, A. R. Marangolo, P. Leite, Jorge Carvalho, Sandra Bolognini, N. Caumo, W. Paik, N. J. Simis, M. Ueda, K. Ekhtiari, H. Luu, P. Tucker, D. M. Tyler, W. J. Brunelin, J. Datta, A. Juan, C. H. Venkatasubramanian, G. Boggio, P. S. Bikson, M. |
| author2_role | author author author author author author author author author author author author author author author author author author author author author |
| author_facet | Fregni, F. Nitsche, M. A. Loo, C. K. Brunoni, A. R. Marangolo, P. Leite, Jorge Carvalho, Sandra Bolognini, N. Caumo, W. Paik, N. J. Simis, M. Ueda, K. Ekhtiari, H. Luu, P. Tucker, D. M. Tyler, W. J. Brunelin, J. Datta, A. Juan, C. H. Venkatasubramanian, G. Boggio, P. S. Bikson, M. |
| author_role | author |
| contributor_name_str_mv | RepositóriUM - Universidade do Minho |
| country_str | PT |
| creators_json_txt | [{\"Person.name\":\"Fregni, F.\"},{\"Person.name\":\"Nitsche, M. A.\"},{\"Person.name\":\"Loo, C. K.\"},{\"Person.name\":\"Brunoni, A. R.\"},{\"Person.name\":\"Marangolo, P.\"},{\"Person.name\":\"Leite, Jorge\"},{\"Person.name\":\"Carvalho, Sandra\"},{\"Person.name\":\"Bolognini, N.\"},{\"Person.name\":\"Caumo, W.\"},{\"Person.name\":\"Paik, N. J.\"},{\"Person.name\":\"Simis, M.\"},{\"Person.name\":\"Ueda, K.\"},{\"Person.name\":\"Ekhtiari, H.\"},{\"Person.name\":\"Luu, P.\"},{\"Person.name\":\"Tucker, D. M.\"},{\"Person.name\":\"Tyler, W. J.\"},{\"Person.name\":\"Brunelin, J.\"},{\"Person.name\":\"Datta, A.\"},{\"Person.name\":\"Juan, C. H.\"},{\"Person.name\":\"Venkatasubramanian, G.\"},{\"Person.name\":\"Boggio, P. S.\"},{\"Person.name\":\"Bikson, M.\"}] |
| datacite.contributors.contributor.contributorName.fl_str_mv | RepositóriUM - Universidade do Minho |
| datacite.creators.creator.creatorName.fl_str_mv | Fregni, F. Nitsche, M. A. Loo, C. K. Brunoni, A. R. Marangolo, P. Leite, Jorge Carvalho, Sandra Bolognini, N. Caumo, W. Paik, N. J. Simis, M. Ueda, K. Ekhtiari, H. Luu, P. Tucker, D. M. Tyler, W. J. Brunelin, J. Datta, A. Juan, C. H. Venkatasubramanian, G. Boggio, P. S. Bikson, M. |
| datacite.date.Accepted.fl_str_mv | 2015-01-01T00:00:00Z |
| datacite.date.available.fl_str_mv | 2021-02-02T07:00:57Z |
| datacite.date.embargoed.fl_str_mv | 2021-02-02T07:00:57Z |
| datacite.rights.fl_str_mv | http://purl.org/coar/access_right/c_abf2 |
| datacite.subjects.subject.fl_str_mv | Regulatory Safety TDCS Ciências Sociais::Psicologia |
| datacite.titles.title.fl_str_mv | Regulatory considerations for the clinical and research use of transcranial Direct Current Stimulation (tDCS): Review and recommendations from an expert panel |
| dc.contributor.none.fl_str_mv | RepositóriUM - Universidade do Minho |
| dc.creator.none.fl_str_mv | Fregni, F. Nitsche, M. A. Loo, C. K. Brunoni, A. R. Marangolo, P. Leite, Jorge Carvalho, Sandra Bolognini, N. Caumo, W. Paik, N. J. Simis, M. Ueda, K. Ekhtiari, H. Luu, P. Tucker, D. M. Tyler, W. J. Brunelin, J. Datta, A. Juan, C. H. Venkatasubramanian, G. Boggio, P. S. Bikson, M. |
| dc.date.Accepted.fl_str_mv | 2015-01-01T00:00:00Z |
| dc.date.available.fl_str_mv | 2021-02-02T07:00:57Z |
| dc.date.embargoed.fl_str_mv | 2021-02-02T07:00:57Z |
| dc.format.none.fl_str_mv | application/pdf |
| dc.identifier.none.fl_str_mv | https://hdl.handle.net/1822/69947 |
| dc.language.none.fl_str_mv | eng |
| dc.publisher.none.fl_str_mv | Informa Healthcare |
| dc.rights.none.fl_str_mv | http://purl.org/coar/access_right/c_abf2 |
| dc.subject.none.fl_str_mv | Regulatory Safety TDCS Ciências Sociais::Psicologia |
| dc.title.fl_str_mv | Regulatory considerations for the clinical and research use of transcranial Direct Current Stimulation (tDCS): Review and recommendations from an expert panel |
| dc.type.none.fl_str_mv | http://purl.org/coar/resource_type/c_6501 |
| description | 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. Therefore, a group of research and clinician experts on tDCS were convened to review the research and clinical use of tDCS. This report reviews the regulatory status of tDCS and summarizes 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 the US. 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. |
| dirty | 0 |
| eu_rights_str_mv | openAccess |
| format | article |
| fulltext.url.fl_str_mv | https://repositorium.uminho.pt/bitstreams/aa1aadc1-e02c-4cc6-a192-8b48e202627a/download |
| id | rum_acaaec37e83b4e3622f0009440c4e817 |
| identifier.url.fl_str_mv | https://hdl.handle.net/1822/69947 |
| instacron_str | repositorium |
| institution | Universidade do Minho |
| instname_str | Universidade do Minho |
| language | eng |
| network_acronym_str | rum |
| network_name_str | RepositóriUM - Universidade do Minho |
| oai_identifier_str | oai:repositorium.uminho.pt:1822/69947 |
| organization_str_mv | urn:organizationAcronym:repositorium |
| person_str_mv | Fregni, F. Nitsche, M. A. Loo, C. K. Brunoni, A. R. Marangolo, P. Leite, Jorge Carvalho, Sandra Bolognini, N. Caumo, W. Paik, N. J. Simis, M. Ueda, K. Ekhtiari, H. Luu, P. Tucker, D. M. Tyler, W. J. Brunelin, J. Datta, A. Juan, C. H. Venkatasubramanian, G. Boggio, P. S. Bikson, M. |
| publishDate | 2015 |
| publisher.none.fl_str_mv | Informa Healthcare |
| reponame_str | RepositóriUM - Universidade do Minho |
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| spelling | engInforma HealthcareporThe 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. Therefore, a group of research and clinician experts on tDCS were convened to review the research and clinical use of tDCS. This report reviews the regulatory status of tDCS and summarizes 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 the US. 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.application/pdfporRegulatory considerations for the clinical and research use of transcranial Direct Current Stimulation (tDCS): Review and recommendations from an expert panelFregni, F.Nitsche, M. A.Loo, C. K.Brunoni, A. R.Marangolo, P.Leite, JorgeCarvalho, SandraBolognini, N.Caumo, W.Paik, N. J.Simis, M.Ueda, K.Ekhtiari, H.Luu, P.Tucker, D. M.Tyler, W. J.Brunelin, J.Datta, A.Juan, C. H.Venkatasubramanian, G.Boggio, P. S.Bikson, M.HostingInstitutionOrganizationalRepositóriUM - Universidade do Minhoe-mailmailto:repositorium@usdb.uminho.ptrepositorium@usdb.uminho.ptCITATIONF. Fregni, M. A. Nitsche, C. K. Loo, A. R. Brunoni, P. Marangolo, J. Leite, S. Carvalho, N. Bolognini, W. Caumo, N. J. Paik, M. Simis, K. Ueda, H. Ekhtiari, P. Luu, D. M. Tucker, W. J. Tyler, J. Brunelin, A. Datta, C. H. Juan, G. Venkatasubramanian, P. S. Boggio & M. Bikson (2015) Regulatory considerations for the clinical and research use of transcranial direct current stimulation (tDCS): Review and recommendations from an expert panel, Clinical Research and Regulatory Affairs, 32:1, 22-35, DOI: 10.3109/10601333.2015.980944ISSNIsPartOf1060-1333EISSNIsPartOf1532-2521DOIIsPartOf10.3109/10601333.2015.9809442021-02-02T07:00:57Z20152021-01-31T15:01:19Z2015-01-01T00:00:00ZHandlehttps://hdl.handle.net/1822/69947http://purl.org/coar/access_right/c_abf2open accessRegulatorySafetyTDCShttp://www.oecd.org/science/inno/38235147.pdfFields of Science and Technology (FOS)Ciências Sociais::Psicologia214792 bytesliteraturehttp://purl.org/coar/resource_type/c_6501journal articlehttp://purl.org/coar/access_right/c_abf2application/pdffulltexthttps://repositorium.uminho.pt/bitstreams/aa1aadc1-e02c-4cc6-a192-8b48e202627a/download |
| spellingShingle | Regulatory considerations for the clinical and research use of transcranial Direct Current Stimulation (tDCS): Review and recommendations from an expert panel Fregni, F. Regulatory Safety TDCS Ciências Sociais::Psicologia |
| status | SINGLETON |
| subject.fl_str_mv | Regulatory Safety TDCS |
| subject.other.fl_str_mv | Ciências Sociais::Psicologia |
| title | Regulatory considerations for the clinical and research use of transcranial Direct Current Stimulation (tDCS): Review and recommendations from an expert panel |
| title_full | Regulatory considerations for the clinical and research use of transcranial Direct Current Stimulation (tDCS): Review and recommendations from an expert panel |
| title_fullStr | Regulatory considerations for the clinical and research use of transcranial Direct Current Stimulation (tDCS): Review and recommendations from an expert panel |
| title_full_unstemmed | Regulatory considerations for the clinical and research use of transcranial Direct Current Stimulation (tDCS): Review and recommendations from an expert panel |
| title_short | Regulatory considerations for the clinical and research use of transcranial Direct Current Stimulation (tDCS): Review and recommendations from an expert panel |
| title_sort | Regulatory considerations for the clinical and research use of transcranial Direct Current Stimulation (tDCS): Review and recommendations from an expert panel |
| topic | Regulatory Safety TDCS Ciências Sociais::Psicologia |
| topic_facet | Regulatory Safety TDCS Ciências Sociais::Psicologia |
| url | https://hdl.handle.net/1822/69947 |
| visible | 1 |