Academic Journal
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).
| Τίτλος: | 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). |
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| Συγγραφείς: | Antal A; Non-Invasive Brain Stimulation Lab, Department of Neurology, University Medical Center Göttingen, Georg August University, Göttingen, Germany., Bjekić J; Human Neuroscience Group, Centre for Neuroscience and Neuromodulation, Institute for Medical Research, University of Belgrade, Serbia. Electronic address: jovana.bjekic@imi.bg.ac.rs., Ganho-Ávila A; Faculty of Psychology and Educational Sciences, University of Coimbra, Rua do Colégio Novo, Coimbra 3000-315, Portugal; Center for Research in Neuropsychology and Cognitive Behavioral Intervention, Faculty of Psychology and Educational Sciences, University of Coimbra, Rua do Colégio Novo 3000-115 Coimbra, Portugal., Alekseichuk I; Stephen M. Stahl Center for Psychiatric Neuroscience, Department of Psychiatry and Behavioral Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA., Assecondi S; Center for Mind/Brain Sciences - CIMeC, University of Trento, Rovereto, TN, Italy., Bergmann TO; Neuroimaging Center (NIC), Focus Program Translational Neuroscience (FTN), Johannes Gutenberg University Medical Center, Mainz, Germany; Leibniz Institute for Resilience Research (LIR), Mainz, Germany., Bikson M; Department of Biomedical Engineering, The City College of New York, NY, USA., Brunelin J; CH Le Vinatier, Université Claude Bernard Lyon 1, CNRS, INSERM, Centre de Recherche en Neurosciences de Lyon CRNL U1028, UMR5292, PsyR2 Team, F-69500 Bron, France., Brunoni AR; Department of Psychiatry and Peter O'Donnell Jr. Brain Institute, UT Southwestern Medical School, Dallas, TX, USA., Charvet L; Department of Neurology, New York University Grossman School of Medicine, New York, NY, USA., Chen R; Division of Neurology, Department of Medicine, University of Toronto and Krembil Research Institute, Toronto, Ontario, Canada., Cohen Kadosh R; School of Psychology, University of Surrey, Guildford, UK; Cognite Neurotechnology Ltd, Oxford, UK., Diedrich L; Non-Invasive Brain Stimulation Lab, Department of Neurology, University Medical Center Göttingen, Georg August University, Göttingen, Germany., D'Urso G; Department of Psychiatry, University of Campania 'Luigi Vanvitelli', Naples, Italy., Ferrucci R; Department of Oncology and Emato-Oncology of University of Milan, Italy; Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy., Filipović SR; Human Neuroscience Group, Centre for Neuroscience and Neuromodulation, Institute for Medical Research, University of Belgrade, Serbia., Fitzgerald PB; School of Medicine and Psychology, Australian National University, Canberra, ACT, Australia., Flöel A; Department of Neurology, University Medicine Greifswald, Greifswald, Germany; German Center for Neurodegenerative Diseases (DZNE), Standort Rostock/Greifswald, Greifswald, Germany., Fröhlich F; Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA., George MS; Brain Stimulation Division, Medical University of South Carolina, and Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC, USA., Hamilton RH; Department of Neurology, University of Pennsylvania, Philadelphia, PA, USA., Haueisen J; Institute of Biomedical Engineering and Informatics, Technische Universität Ilmenau, Germany., Hallett M; Human Motor Control Section, National Institute of Neurological Disorders and Stroke, NIH, Bethesda, MD, USA., Herrmann CS; Experimental Psychology Lab, Department of Psychology, European Medical School, Carl von Ossietzky Universität, Oldenburg, Germany., Hummel FC; Department of Neurology, University Hospital Würzburg, Würzburg, Germany; Defitech Chair of Clinical Neuroengineering, Neuro-X Institute (INX), EPFL Valais, Clinique Romande de Réadaptation Sion, Switzerland; Clinical Neuroscience, University of Geneva Medical School, Geneva, Switzerland., Jaberzadeh S; Monash University, Victoria 3199, Australia., Langguth B; Department of Psychiatry and Psychotherapy, University of Regensburg at Bezirksklinikum, Germany., Lavidor M; Department of Psychology and the Gonda Brain Research Center, Bar Ilan University, Ramat Gan, Israel., Lefaucheur JP; Department of Clinical Neurophysiology, Henri Mondor Hospital, Assistance Publique - Hôpitaux de Paris, France; UR 4391, Nerve Excitability and Therapeutic team (ENT), Faculty of Medicine, Paris Est Créteil University, Créteil, France., Miniussi C; Center for Mind/Brain Sciences - CIMeC, University of Trento, Rovereto, TN, Italy., Moliadze V; Institute of Medical Psychology and Medical Sociology, University Medical Center Schleswig-Holstein, Kiel University, Kiel, Germany., Nikander M; Sooma Oy, Atomitie 5C, Helsinki, Finland., Nikolin S; University of New South Wales, Sydney, Australia., Nitsche MA; Department of Psychology and Neurosciences, Leibniz Research Centre for Working Environment and Human Factors, Dortmund, Germany; German Centre for Mental Health (DZPG), Bochum, Germany; Bielefeld University, University Hospital OWL, Protestant Hospital of Bethel Foundation, University Clinic of Psychiatry and Psychotherapy, Germany., Opitz A; Department of Biomedical Engineering, University of Minnesota, Minneapolis, USA., O'Shea J; Oxford Centre for Human Brain Activity (OHBA), Department of Psychiatry, Warneford Hospital, University of Oxford, OX3 7JX, UK., Padberg F; Department of Psychiatry and Psychotherapy, Center for Neurostimulation (CNS), LMU University Hospital, Munich, Germany; DZPG (German Center for Mental Health), Partner Site Munich-Augsburg, Munich, Germany., Plewnia C; Department of Psychiatry and Psychotherapy, Neurophysiology & Interventional Neuropsychiatry, University of Tübingen, Germany; German Center for Mental Health (DZPG), Germany., Priori A; Clinica Neurologica III, ASST Santi Paolo e Carlo di Milano, Dipartimento di Scienze della Salute, Università degli Studi di Milano, Italy., Ramasawmy P; Non-Invasive Brain Stimulation Lab, Department of Neurology, University Medical Center Göttingen, Georg August University, Göttingen, Germany., Razza LB; Ghent Experimental Psychiatry (GHEP) Lab, Faculty of Medicine and Health Sciences, Department of Head and Skin, Ghent University, Ghent, Belgium., Rossi S; Department of Medicine, Surgery and Neuroscience, Neurology and Clinical Neurophysiology Section, Brain Investigation & Neuromodulation Lab, University of Siena, Italy., Rothwell J; UCL Institute of Neurology, London, UK., Rueger MA; University of Cologne, Faculty of Medicine and University Hospital, Department of Neurology, Cologne, Germany., Ruffini G; Neuroelectrics, Av. Tibidabo 47bis, 08035 Barcelona, Spain., Sack AT; Department of Cognitive Neuroscience, Faculty of Psychology and Neuroscience, Maastricht University, Netherlands (the)., Salvador R; Neuroelectrics, Av. Tibidabo 47bis, 08035 Barcelona, Spain., Schellhorn K; Neurocare Group AG, Albert-Einstein-Str. 3, Ilmenau, Germany., Schuhmann T; Department of Cognitive Neuroscience, Faculty of Psychology and Neuroscience, Maastricht University, Netherlands (the)., Shirota Y; Department of Clinical Laboratory, the University of Tokyo Hospital, Tokyo, Japan., Siebner HR; Danish Research Centre for Magnetic Resonance, Department of Radiology and Nuclear Medicine, Copenhagen University Hospital Amager and Hvidovre, Hvidovre, Denmark; Department of Neurology, Copenhagen University Hospital Bispebjerg and Frederiksberg, Copenhagen, Denmark; Institute for Clinical Medicine, Faculty of Health Sciences, University of Copenhagen, Copenhagen, Denmark., Thielscher A; Danish Research Centre for Magnetic Resonance, Department of Radiology and Nuclear Medicine, Copenhagen University Hospital Amager and Hvidovre, Hvidovre, Denmark; Department of Health Technology, Technical University of Denmark, Kongens Lyngby, Denmark., Ugawa Y; Department of Human Neurophysiology, Fukushima Medical University, Japan., Uusitalo S; Department of History, Culture and Communication Studies/ Philosophy, University of Oulu, Finland., Wexler A; Department of Medical Ethics and Health Policy, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA., Paulus W; Department of Neurology, Ludwig Maximilians University, Munich, Germany., Vanderhasselt MA; Ghent University, Ghent, Belgium., Van Waes V; Université Marie et Louis Pasteur, INSERM, UMR 1322 LINC, F-25000 Besançon, France., Wessel MJ; Department of Neurology, University Hospital Würzburg, Würzburg, Germany., Wischnewski M; Department of Psychology, University of Groningen, Groningen, Netherlands (the)., Baeken C; Ghent Experimental Psychiatry (GHEP) Lab, Faculty of Medicine and Health Sciences, Department of Head and Skin, Ghent University, Ghent, Belgium; Department of Psychiatry, University Hospital Brussel (UZ Brussel), Brussels, Belgium; Neuroprotection and Neuromodulation Research Group (NEUR), Center for Neurosciences (C4N), Vrije Universiteit Brussel (VUB), Brussels, Belgium; Department of Electrical Engineering, Eindhoven University of Technology, Eindhoven, Netherlands (the)., Ziemann U; Department of Neurology & Stroke, and Hertie Institute for Clinical Brain Research, University of Tübingen, Tübingen, Germany. |
| Πηγή: | Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology [Clin Neurophysiol] 2026 Apr; Vol. 184, pp. 2111436. Date of Electronic Publication: 2025 Nov 23. |
| Τύπος έκδοσης: | Journal Article; Review |
| Γλώσσα: | English |
| Στοιχεία περιοδικού: | Publisher: Elsevier Country of Publication: Netherlands NLM ID: 100883319 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1872-8952 (Electronic) Linking ISSN: 13882457 NLM ISO Abbreviation: Clin Neurophysiol Subsets: MEDLINE |
| Imprint Name(s): | Original Publication: Amsterdam : Elsevier, c1999- |
| Ιατρικοί όροι (MeSH): | Transcranial Direct Current Stimulation*/adverse effects , Transcranial Direct Current Stimulation*/methods , Transcranial Direct Current Stimulation*/standards , Transcranial Direct Current Stimulation*/ethics , Neurophysiology*/legislation & jurisprudence , Brain*/physiology, Humans ; Europe |
| Περίληψη: | 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. (Copyright © 2025 The Author(s). Published by Elsevier B.V. All rights reserved.) |
| Competing Interests: | Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: AA is the vice president of the European Society for Brain Stimulation, Member-at-Large at the EMEAC – IFCN, she serves as a paid consultant at NeuroConn, Ilmenau, and she is a paid advisor at Electromedical Products International (Pulvinar), USA. Member of the advisory board at PlatoScience, has non-financial support from Sooma Medical, she is Paid Editor by Elsevier. AGA has nonfinancial support for research from Flow Neuroscience and Sooma Medical. ATS is Chief Scientific Advisor of PlatoScience, Scientfic Advisor of Alphasys, Funder and Dierector of the Academy of Brain Stimulation and the AoBS Foundation as well as the International Clinical TMS Certification Course, receiving equpment support from MagVenture, MagStim, Deymed, Yingchi, Brainsway. CSH holds a patent on transcranial brain stimulation. FF is a paid consultant and shareholder of Electromedical Products International (EPI) and is the inventor of non-invasive brain stimulation technology for which he receives royalty payments from UNC. FP is a member of the European Scientific Advisory Board of BrainsWay Inc. (Jerusalem, Israel), and the International Scientific Advisory Board of Sooma (Helsinki, Finland); he has received speaker honoraria from Mag&More GmbH, and the neuroCare Group (Munich, Germany); his lab has received support with equipment from neuroConn GmbH (Ilmenau, Germany), Mag&More GmbH, and BrainsWay Inc. HRS has received honoraria as speaker and consultant from Lundbeck AS, Denmark, and as editor (Neuroimage Clinical) from Elsevier Publishers, Amsterdam, The Netherlands. He has received royalties as book edi ni mi tor from Springer Publishers, Stuttgart, Germany, Oxford University Press, Oxford, UK, and from Gyldendal Publishers, Copenhagen, Denmark. KS is an employee and shareholder of Neurocare group AG. LC has received speaker fees from Soterix Medical and serves as a consultant for Syntropic Medical and Ceragem. LD has received nonfinancial support for research from NeuroCare. He has received honorarium from NeuroCare for a training course. MAN is a member of the Scientific Advisory Boards of Neuroelectrics and Precisis. MSG serves as a consultant to Abbott (DBS), Livanova (VNS) and Neuralief (trigeminal). He has ongoing grants from Livanova and Abbott. In the last 3 years PBF has received equipment for research from Neurosoft and Nexstim. He has served on a scientific advisory board for Magstim and received speaker fees from Otsuka. He has also acted as a founder and board member for TMS Clinics Australia and Resonance Therapeutics. PR has received nonfinancial support for research from Sooma Medical™, NeuroCare, and QuantalX Neuroscience. He has received honorarium from NeuroCare for a training course. RCK serves on the scientific advisory boards of Neuroelectrics Inc., Innosphere Inc., is the founder and shareholder of Cognite Neurotechnology Ltd. RF and AP are shareholder of Newronika SpA, Italy. SA is named inventor on a patent application (WO/2022/106850) jointly submitted by the University of Birmingham (UK), and Dalhousie University (CA), titled “Improving cognitive function”. SR is member of the advisory board of Sinaptica therapeutics. UZ serves on the scientific advisory board of CorTec GmbH (Freiburg, Germany). Other authors have no conflict of interest to declare. |
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| Grant Information: | 215451 United Kingdom WT_ Wellcome Trust |
| Contributed Indexing: | Keywords: Adverse events; Ethics; Regulation; Safety; Training; tACS; tDCS; tES |
| Entry Date(s): | Date Created: 20260201 Date Completed: 20260706 Latest Revision: 20261001 |
| Update Code: | 20261001 |
| PubMed Central ID: | PMC7618810 |
| DOI: | 10.1016/j.clinph.2025.2111436 |
| PMID: | 41622107 |
| Βάση Δεδομένων: | MEDLINE |
| ISSN: | 1872-8952 |
|---|---|
| DOI: | 10.1016/j.clinph.2025.2111436 |