Regulation and Ethics of Transcranial Electrical Stimulation: A General View
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Neurophysiology, Vol. 52, No. 3, May, 2020
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Regulation and Ethics of Transcranial Electrical Stimulation: A General View A. Molero-Chamizo,1 M. Á. S. Sánchez,1 R. M. Riquel,2 C. Gutiérrez Lérida,1 and G. N. Rivera-Urbina3 Received February 21, 2020 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.
Keywords: non-invasive brain stimulation, transcranial electrical stimulation, ethics, health, safety, legal regulation.
INTRODUCTION In humans, the use of electrical stimuli of suf ficiently low intensities applied transcranially is a non-invasive and safe procedure to induce changes in the cortical excitability [1–5]. The capability of this technique to alter the state of excitability of cortical neurons has been used for research and clinical purposes for some years. Hospitals, medical and clinical centers, universities, and research centers around the world have used different versions of the transcranial electrical stimulation (tES) procedure (Table 1), such as transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), transcranial pulsed current stimulation (tPCS), transcranial random noise stimulation (tRNS), or even transcutaneous spinal direct current stimulation (tsSDCS), and this
Department of Psychology, University of Huelva, Huelva, Spain; Department of Psychology, University of Córdoba, Córdoba, Spain; 3 Autonomous University of Baja California, Mexicali, México. Correspondence should be addressed to A. Molero-Chamizo (e-mail: [email protected]). 1 2
use has been increasing in an exceptional way. The simplicity of the device in inducing alte rations of the cortical excitability, the relatively low cost compared to that of other stimulation techniques, and portability and easy handling of the tES devices have ensured that this procedure is widely used all over the world and that its application is increasingly extended. Recently, even magnetic resonance imaging (MR
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