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)

作者：Andrea Antal, Jovana Bjekić, Ana Ganho-Ávila, Ivan Alekseichuk, Sara Assecondi, Til Ole Bergmann, Marom Bikson, Jérôme Brunelin, André R. Brunoni, Leigh Elkins Charvet, Robert E. Chen, Roi Cohen Kadosh, Lukas Diedrich, Giordano D’Urso, Roberta Ferrucci, Saša R. Filipović, Paul Bernard Fitzgerald, Agnes Flöel, Flavio Frӧhlich, Mark S. George, Roy H. Hamilton, Jens Haueisen, Mark Hallett, Christoph Siegfried Herrmann, Friedhelm Christoph Hummel, Shapour J. Jaberzadeh, B. Langguth, Michal Lavidor, Jean‐Pascal Lefaucheur, Carlo Miniussi, Vera Moliadze, Mika Nikander, Stevan Nikolin, Michael Andreas Nitsche, Alexander Opitz, Jacinta O’Shea, Frank Padberg, Christian Plewnia, Alberto Priori, Perianen Ramasawmy, Laís Boralli Razza, Símone Rossi, John C. Rothwell, Maria Adele Rueger, Giulio Ruffini, Alexander Thomas Sack, Ricardo Salvador, Klaus Schellhorn, Teresa Schuhmann, Y. Shirota, Hartwig Roman Siebner, Axel Thielscher, Yoshikazu Ugawa, Susanne Uusitalo, Anna Wexler, Walter Paulus, Marie–Anne Vanderhasselt, Vincent Van Waes, Maximilian J. Wessel, Miles Wischnewski, Chris Baeken, Ulf Ziemann · 发表于：Clinical Neurophysiology · 年份：2025 · DOI：10.1016/j.clinph.2025.2111436 · 被引用次数：42 · 研究领域：Transcranial Magnetic Stimulation Studies、Electroconvulsive Therapy Studies、Electromagnetic Fields and Biological Effects

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 studie...