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Regulatory Aspects

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Transcranial Direct Current Stimulation in Neuropsychiatric Disorders

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Abstract

The increased research on transcranial direct current stimulation (tDCS) around the world reflects its potential as a therapeutic tool for many neuropsychiatric disorders. The simple technology and positive results on safety and efficacy have led to its increased use in research and clinical practice. However, there is no current regulation of tDCS by the Food and Drug Administration (FDA) in the USA for clinical use. Most of the tDCS studies are considered of minimal risk, requiring only the Internal Review Board (IRB) approval to conduct a research study. Uses other than research include off-label and compassionate treatments. Special considerations on patient selection and the application of tDCS must be taken into account to optimize the technique and guarantee a safe practice. Further knowledge of tDCS experience in other countries and their combined efforts can help to promote the appropriate and safe use of this technique.

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Abbreviations

CE:

Conformité Européene

CES:

Cranial electrotherapy stimulation

FDA:

Food and Drug Administration

HD-tDCS:

High-definition transcranial direct current stimulation

IDE:

Investigational device exemption

IRB:

Institutional Review Board

NIBS:

Noninvasive brain stimulation

NSR:

Nonsignificant risk

PMA:

Premarket approval

SR:

Significant risk

tDCS:

Transcranial direct current stimulation

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Author information

Authors and Affiliations

  1. Spaulding Neuromodulation Center, Spaulding Rehabilitation Hospital, Harvard Medical School, Charlestown, MA, USA

    Alejandra Vasquez & Felipe Fregni

Authors
  1. Alejandra Vasquez
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  2. Felipe Fregni
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Correspondence to Felipe Fregni .

Editor information

Editors and Affiliations

  1. Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil

    André R. Brunoni

  2. Department of Psychology and Neurosciences, Leibniz Research Centre for Working Environment and Human Factors, Dortmund, Germany

    Michael A. Nitsche

  3. Black Dog Institute & School of Psychiatry, University of New South Wales, Sydney, Australia

    Colleen K. Loo

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Vasquez, A., Fregni, F. (2021). Regulatory Aspects. In: Brunoni, A.R., Nitsche, M.A., Loo, C.K. (eds) Transcranial Direct Current Stimulation in Neuropsychiatric Disorders. Springer, Cham. https://doi.org/10.1007/978-3-030-76136-3_40

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  • DOI: https://doi.org/10.1007/978-3-030-76136-3_40

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