Regulatory considerations for the clinical and research use of transcranial direct current stimulation (tDCS): Review and recommendations from an expert panel

F. 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, William Tyler, J. Brunelin, A. Datta, C. H. Juan, G. VenkatasubramanianP. S. Boggio, M. Bikson

Research output: Contribution to journalArticle

103 Citations (Scopus)

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. 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.

Original languageEnglish (US)
Pages (from-to)22-35
Number of pages14
JournalClinical Research and Regulatory Affairs
Volume32
Issue number1
DOIs
StatePublished - Mar 1 2015
Externally publishedYes

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Research
Compassionate Use Trials
Off-Label Use
Transcranial Direct Current Stimulation
Republic of Korea
Portugal
Neurosciences
Iran
Taiwan
Italy
France
Germany
Brazil
India
Randomized Controlled Trials
Therapeutics
Growth

Keywords

  • Regulatory
  • Safety
  • TDCS

ASJC Scopus subject areas

  • Pharmaceutical Science
  • Pharmacology
  • Pharmacology (medical)

Cite this

Regulatory considerations for the clinical and research use of transcranial direct current stimulation (tDCS) : Review and recommendations from an expert panel. / Fregni, F.; Nitsche, M. A.; Loo, C. K.; Brunoni, A. R.; Marangolo, P.; Leite, J.; Carvalho, S.; Bolognini, N.; Caumo, W.; Paik, N. J.; Simis, M.; Ueda, K.; Ekhtiari, H.; Luu, P.; Tucker, D. M.; Tyler, William; Brunelin, J.; Datta, A.; Juan, C. H.; Venkatasubramanian, G.; Boggio, P. S.; Bikson, M.

In: Clinical Research and Regulatory Affairs, Vol. 32, No. 1, 01.03.2015, p. 22-35.

Research output: Contribution to journalArticle

Fregni, F, Nitsche, MA, Loo, CK, Brunoni, AR, Marangolo, P, Leite, J, Carvalho, S, Bolognini, N, Caumo, W, Paik, NJ, Simis, M, Ueda, K, Ekhtiari, H, Luu, P, Tucker, DM, Tyler, W, Brunelin, J, Datta, A, Juan, CH, Venkatasubramanian, G, Boggio, PS & Bikson, M 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, vol. 32, no. 1, pp. 22-35. https://doi.org/10.3109/10601333.2015.980944
Fregni, F. ; Nitsche, M. A. ; Loo, C. K. ; Brunoni, A. R. ; Marangolo, P. ; Leite, J. ; Carvalho, S. ; Bolognini, N. ; Caumo, W. ; Paik, N. J. ; Simis, M. ; Ueda, K. ; Ekhtiari, H. ; Luu, P. ; Tucker, D. M. ; Tyler, William ; Brunelin, J. ; Datta, A. ; Juan, C. H. ; Venkatasubramanian, G. ; Boggio, P. S. ; Bikson, M. / Regulatory considerations for the clinical and research use of transcranial direct current stimulation (tDCS) : Review and recommendations from an expert panel. In: Clinical Research and Regulatory Affairs. 2015 ; Vol. 32, No. 1. pp. 22-35.
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