Tehran University of Medical Sciences

Science Communicator Platform

Stay connected! Follow us on X network (Twitter):
Share this content! On (X network) By
Regulatory Considerations for the Clinical and Research Use of Transcranial Direct Current Stimulation (Tdcs): Review and Recommendations From an Expert Panel Publisher



Fregni F1 ; Nitsche MA2 ; Loo CK3 ; Brunoni AR4 ; Marangolo P5 ; Leite J1, 6 ; Carvalho S1, 6 ; Bolognini N7, 8 ; Caumo W9 ; Paik NJ10 ; Simis M11, 12 ; Ueda K13 ; Ekhtiari H14, 15 ; Luu P16 Show All Authors
Authors
  1. Fregni F1
  2. Nitsche MA2
  3. Loo CK3
  4. Brunoni AR4
  5. Marangolo P5
  6. Leite J1, 6
  7. Carvalho S1, 6
  8. Bolognini N7, 8
  9. Caumo W9
  10. Paik NJ10
  11. Simis M11, 12
  12. Ueda K13
  13. Ekhtiari H14, 15
  14. Luu P16
  15. Tucker DM16
  16. Tyler WJ17
  17. Brunelin J18
  18. Datta A19
  19. Juan CH20
  20. Venkatasubramanian G21
  21. Boggio PS22
  22. Bikson M19
Show Affiliations
Authors Affiliations
  1. 1. Spaulding Neuromodulation Center, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, MA, United States
  2. 2. Department of Clinical Neurophysiology, Georg-August-University, Gottingen, Germany
  3. 3. School of Psychiatry, Black Dog Institute, University of New South Wales, Sydney, Australia
  4. 4. Service of Interdisciplinary Neuromodulation, Department and Institute of Psychiatry, University of Sao Paulo, Sao Paulo, Brazil
  5. 5. Department of Experimental and Clinical Medicine, University Politecnica Delle Marche, Ancona, IRCCS Fondazione Santa Lucia, Rome, Italy
  6. 6. School of Psychology (EPsi), University of Minho, Campus de Gualtar, Braga, Portugal
  7. 7. Department of Psychology, University of Milano Bicocca, Milan, Italy
  8. 8. Laboratory of Neuropsychology, IRCC Instituto Auxologico Italiano, Milan, Italy
  9. 9. Laboratory of Pain and Neuromodulation, Hospital de Clinicas de Porto Alegre, UFRGS, Porto Alegre, Brazil
  10. 10. Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seoul, South Korea
  11. 11. Institute of Physical Medicine and Rehabilitation, Clinics Hospital, University of Sao Paulo Medical School, Sao Paolo, Brazil
  12. 12. Division of Neurology, Santa Casa Medical School, Sao Paulo, Brazil
  13. 13. National Cardiovascular Center, Osaka, Japan
  14. 14. Translational Neuroscience Program, Institute for Cognitive Science Studies, Tehran, Iran
  15. 15. Neurocognitive Laboratory, Iranian National Center for Addiction Studies, Tehran University of Medical Sciences, Tehran, Iran
  16. 16. Electrical Geodesics, Inc., University of Oregon, Eugene, OR, United States
  17. 17. Virginia Tech Carilion Research Institute, Department of Psychiatry and Behavioral Medicine, School of Biomedical Engineering and Sciences, Roanoke, VA, United States
  18. 18. EA 4615, Centre Hospitalier le Vinatier, Universite de Lyon, Bron, F-69003, France
  19. 19. Department of Biomedical Engineering, Neural Engineering Laboratory, City College of the City University of New York, New York, NY, United States
  20. 20. Institute of Cognitive Neuroscience, National Central University, Taiwan
  21. 21. Translational Psychiatry Laboratory, Department of Psychiatry, National Institute of Mental Health and Neurosciences, Bangalore, India
  22. 22. Developmental Disorders Program, Center for Healthy and Biological Sciences, Mackenzie Presbyterian University, Sao Paulo, Brazil

Source: Clinical Research and Regulatory Affairs Published:2015


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. © 2014 Informa Healthcare USA, Inc. All rights reserved.
Other Related Docs
20. Fmri and Transcranial Electrical Stimulation (Tes): A Systematic Review of Parameter Space and Outcomes, Progress in Neuro-Psychopharmacology and Biological Psychiatry (2021)
35. Effects of Primary Motor Cortex Noninvasive Brain Stimulation on Post-Stroke Aphasia: A Narrative Review, Egyptian Journal of Neurology# Psychiatry and Neurosurgery (2023)
39. Tinnitus Rehabilitation Through Electrical Stimulation As a Neuromodulation Method: A Scoping Review, Indian Journal of Otolaryngology and Head and Neck Surgery (2025)