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@ARTICLE{Antal:285468,
      author       = {Antal, Andrea and Bjekić, Jovana and Ganho-Ávila, Ana and
                      Alekseichuk, Ivan and Assecondi, Sara and Bergmann, Til Ole
                      and Bikson, Marom and Brunelin, Jerome and Brunoni, Andre R
                      and Charvet, Leigh and Chen, Robert and Cohen Kadosh, Roi
                      and Diedrich, Lukas and D'Urso, Giordano and Ferrucci,
                      Roberta and Filipović, Saša R and Fitzgerald, Paul B and
                      Flöel, Agnes and Fröhlich, Flavio and George, Mark S and
                      Hamilton, Roy H and Haueisen, Jens and Hallett, Mark and
                      Herrmann, Christoph S and Hummel, Friedhelm C and
                      Jaberzadeh, Shapour and Langguth, Berthold and Lavidor,
                      Michal and Lefaucheur, Jean-Pascal and Miniussi, Carlo and
                      Moliadze, Vera and Nikander, Mika and Nikolin, Stevan and
                      Nitsche, Michael A and Opitz, Alexander and O'Shea, Jacinta
                      and Padberg, Frank and Plewnia, Christian and Priori,
                      Alberto and Ramasawmy, Perianen and Razza, Lais B and Rossi,
                      Simone and Rothwell, John and Rueger, Maria A and Ruffini,
                      Giulio and Sack, Alexander T and Salvador, Ricardo and
                      Schellhorn, Klaus and Schuhmann, Teresa and Shirota,
                      Yuichiro and Siebner, Hartwig Roman and Thielscher, Axel and
                      Ugawa, Yoshikazu and Uusitalo, Susanne and Wexler, Anna and
                      Paulus, Walter and Vanderhasselt, Marie-Anne and Van Waes,
                      Vincent and Wessel, Maximilian J and Wischnewski, Miles and
                      Baeken, Chris and Ziemann, Ulf},
      title        = {{L}ow intensity transcranial electric stimulation:
                      {S}afety, ethical, legal regulatory and application
                      guidelines (2017-2025: {A}n update) - endorsed by the
                      {E}uropean {S}ociety for {B}rain {S}timulation ({ESBS}) and
                      by the {I}nternational {F}ederation for {C}linical
                      {N}europhysiology ({IFCN}).},
      journal      = {Clinical neurophysiology},
      volume       = {184},
      issn         = {1388-2457},
      address      = {Amsterdam [u.a.]},
      publisher    = {Elsevier Science},
      reportid     = {DZNE-2026-00245},
      pages        = {2111436},
      year         = {2026},
      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.},
      subtyp        = {Review Article},
      keywords     = {Humans / Transcranial Direct Current Stimulation: adverse
                      effects / Transcranial Direct Current Stimulation: standards
                      / Transcranial Direct Current Stimulation: methods /
                      Transcranial Direct Current Stimulation: ethics / Societies,
                      Medical: standards / Neurophysiology: legislation $\&$
                      jurisprudence / Neurophysiology: standards / Europe /
                      Transcranial Magnetic Stimulation / Brain: physiology /
                      Adverse events (Other) / Ethics (Other) / Regulation (Other)
                      / Safety (Other) / Training (Other) / tACS (Other) / tDCS
                      (Other) / tES (Other)},
      cin          = {AG Flöel},
      ddc          = {610},
      cid          = {I:(DE-2719)5000081},
      pnm          = {353 - Clinical and Health Care Research (POF4-353)},
      pid          = {G:(DE-HGF)POF4-353},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:41622107},
      pmc          = {pmc:PMC7618810},
      doi          = {10.1016/j.clinph.2025.2111436},
      url          = {https://pub.dzne.de/record/285468},
}