Journal Article (Review Article)

DZNE-2026-00245

http://join2-wiki.gsi.de/foswiki/pub/Main/Artwork/join2_logo100x88.png Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines (2017-2025: An update) - endorsed by the European Society for Brain Stimulation (ESBS) and by the International Federation for Clinical Neurophysiology (IFCN).

Antal, A. ; Bjekić, J. ; Ganho-Ávila, A. ; Alekseichuk, I. ; Assecondi, S. ; Bergmann, T. O. ; Bikson, M. ; Brunelin, J. ; Brunoni, A. R. ; Charvet, L. ; Chen, R. ; Cohen Kadosh, R. ; Diedrich, L. ; D'Urso, G. ; Ferrucci, R. ; Filipović, S. R. ; Fitzgerald, P. B. ; Flöel, A.DZNE* ; Fröhlich, F. ; George, M. S. ; Hamilton, R. H. ; Haueisen, J. ; Hallett, M. ; Herrmann, C. S. ; Hummel, F. C. ; Jaberzadeh, S. ; Langguth, B. ; Lavidor, M. ; Lefaucheur, J.-P. ; Miniussi, C. ; Moliadze, V. ; Nikander, M. ; Nikolin, S. ; Nitsche, M. A. ; Opitz, A. ; O'Shea, J. ; Padberg, F. ; Plewnia, C. ; Priori, A. ; Ramasawmy, P. ; Razza, L. B. ; Rossi, S. ; Rothwell, J. ; Rueger, M. A. ; Ruffini, G. ; Sack, A. T. ; Salvador, R. ; Schellhorn, K. ; Schuhmann, T. ; Shirota, Y. ; Siebner, H. R. ; Thielscher, A. ; Ugawa, Y. ; Uusitalo, S. ; Wexler, A. ; Paulus, W. ; Vanderhasselt, M.-A. ; Van Waes, V. ; Wessel, M. J. ; Wischnewski, M. ; Baeken, C. ; Ziemann, U.

2026
Elsevier Science Amsterdam [u.a.]

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Please use a persistent id in citations: doi:10.1016/j.clinph.2025.2111436

Abstract: This guideline summarizes updated safety data (2017-2025) and provides expert recommendations on the use of low intensity transcranial electrical stimulation (tES) in humans. tES encompasses several techniques including transcranial direct current stimulation (tDCS), oscillatory transcranial direct current stimulation (otDCS), transcranial alternating current stimulation (tACS), transcranial random noise stimulation (tRNS), transcranial temporal interference stimulation (tTIS), and their combinations or variations. Across over 300,000 sessions involving healthy individuals, patients with neuropsychiatric conditions, and other clinical populations, no tES-related serious adverse events (AEs) have been reported. Moderate AEs are rare and limited to a small range of specific applications. Mild AEs are common and include transient symptoms such as localized sensations (e.g., tingling or burning), headaches, and fatigue. Similar mild AEs are also reported by individuals receiving placebo stimulation. The frequency, magnitude, and type of AEs are comparable across healthy, clinical, and vulnerable groups, including children, elderly, or pregnant women. Combined interventions (e.g., co-application with EEG, TMS, or neuroimaging) have not shown increased safety risks. Safety is well-established for both bipolar and multichannel tES when applied up to 4 mA and up to 60 min per day. Higher intensities and longer stimulation durations may also be safe. Nevertheless, the number of studies using intensities above 4 mA or stimulating longer than 60 min is low. Home-based use of treatments is growing rapidly, leveraging remote supervision to provide patients with greater access and enable repeated, sustained dosing paradigms. We recommend using screening and AE questionnaires in future controlled studies, in particular when planning to extend the stimulation parameters applied. We discuss recent regulatory and ethical issues.

Keyword(s): Humans (MeSH) ; Transcranial Direct Current Stimulation: adverse effects (MeSH) ; Transcranial Direct Current Stimulation: standards (MeSH) ; Transcranial Direct Current Stimulation: methods (MeSH) ; Transcranial Direct Current Stimulation: ethics (MeSH) ; Societies, Medical: standards (MeSH) ; Neurophysiology: legislation & jurisprudence (MeSH) ; Neurophysiology: standards (MeSH) ; Europe (MeSH) ; Transcranial Magnetic Stimulation (MeSH) ; Brain: physiology (MeSH) ; Adverse events ; Ethics ; Regulation ; Safety ; Training ; tACS ; tDCS ; tES

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Contributing Institute(s):

1. Dementia Prevention – Mechanisms and Clinical Implementation (AG Flöel)

Research Program(s):

1. 353 - Clinical and Health Care Research (POF4-353) (POF4-353)

Appears in the scientific report 2026

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Database coverage:
; BIOSIS Previews ; Biological Abstracts ; Clarivate Analytics Master Journal List ; Current Contents - Life Sciences ; Ebsco Academic Search ; Essential Science Indicators ; IF < 5 ; JCR ; Nationallizenz ; SCOPUS ; Science Citation Index Expanded ; Web of Science Core Collection

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