Regulation and Ethics of Transcranial Electrical Stimulation: A General View

Abstract

Transcranial application of low-intensity electrical stimuli is a non-invasive brain stimulation procedure, which allows one to alter the excitability of cortical cells in both humans and animals. There is a broad consensus regarding the safety of this approach in humans, and different versions and protocols of this technique have been used in basic research and clinical studies for years. In this review, we aim to provide updated information on regulatory and ethical issues concerning the use of different versions of transcranial electrical stimulation (tES). This information may be critical due to its implications on the welfare and health of patients. Although tES is a safe and effective method with potential clinical and research utilities, the legal regulation criteria concerning the use different versions of tES are of critical relevance due to implications of brain stimulation for human health and well-being. Recent publications that review and describe all regulatory and safety aspects regarding the use of tES offer a practical vision about the most up-to-date information in this field and more relevant ethical implications.