Review and regulation of clinical and research applications of tDCS
Clin Res Regul Aff, Early Online: 1–14
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, W. J. Tyler, J. Brunelin, A. Datta, C. H. Juan, G. Venkatasubramanian, P. S. Boggio, and M. Bikson
tES electrical brain stimulation has experienced significant growth in the last 15 years. One of the methods of electrical stimulation that has had the greatest impact on this growth is stimulation using direct current. Significant research efforts have been made to determine the clinical potential of this method, and despite the promising results in clinical and basic neurosciences, the lack of specific international supervision has prevented its further progress. For this purpose, a group of researchers and therapists specializing in this field reviewed and investigated the applications of this method in the field of research and treatment. This review article has looked at the status of tDCS in Australia, Brazil, France, Germany, India, Iran, Italy, Portugal, South Korea, Taiwan and the United States and summarized the results based on research use and off-label treatment.
It is necessary to organize a global or regional effort to pursue definitive evidence to approve, regulate, and limit the use of tDCS.
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.