Regulatory aspects

Abstract

The increased research on transcranial direct current stimulation (tDCS) around the world refl ects 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 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.