Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines

  1. Antal, Andrea
  2. Alekseichuk, Ivan ORCID logo
  3. Bikson, Marom
  4. Brockmöller, Jürgen
  5. Russowsky Brunoni, Andre ORCID logo
  6. Chen, Robert
  7. Cohen, Leonardo G.
  8. Dowthwaite, G.
  9. Ellrich, Jens
  10. Flöel, Agnes
  11. Fregni, Felipe F.
  12. George, Mark S.
  13. Hamilton, Roy H.
  14. Haueisen, Jens ORCID logo
  15. Herrmann, Christoph ORCID logo
  16. Hummel, Friedhelm
  17. Lefaucheur, Jean-Pascal
  18. Liebetanz, David
  19. Loo, Colleen K.
  20. McCaig, Colin D.
  21. Miniussi, Carlo ORCID logo
  22. Miranda, Pedro C.
  23. Moliadze, Vera
  24. Nitsche, Michael ORCID logo
  25. Nowak, R.
  26. Padberg, Frank
  27. Pascual-Leone, Alvaro
  28. Poppendieck, Wigand
  29. Priori, Alberto
  30. Rossi, Símone
  31. Rossini, P. M.
  32. Rothwell, John C.
  33. Rueger, Maria Adele
  34. Ruffini, Giulio
  35. Schellhorn, Klaus
  36. Siebner, Hartwig Roman
  37. Ugawa, Yoshikazu
  38. Wexler, Anna
  39. Ziemann, Ulf
  40. Hallett, Mark
  41. Paulus, Walter M.

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WeightNameValue
1000 Titel
  • Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines
1000 Autor/in
  1. Antal, Andrea |
  2. Alekseichuk, Ivan |
  3. Bikson, Marom |
  4. Brockmöller, Jürgen |
  5. Russowsky Brunoni, Andre |
  6. Chen, Robert |
  7. Cohen, Leonardo G. |
  8. Dowthwaite, G. |
  9. Ellrich, Jens |
  10. Flöel, Agnes |
  11. Fregni, Felipe F. |
  12. George, Mark S. |
  13. Hamilton, Roy H. |
  14. Haueisen, Jens |
  15. Herrmann, Christoph |
  16. Hummel, Friedhelm |
  17. Lefaucheur, Jean-Pascal |
  18. Liebetanz, David |
  19. Loo, Colleen K. |
  20. McCaig, Colin D. |
  21. Miniussi, Carlo |
  22. Miranda, Pedro C. |
  23. Moliadze, Vera |
  24. Nitsche, Michael |
  25. Nowak, R. |
  26. Padberg, Frank |
  27. Pascual-Leone, Alvaro |
  28. Poppendieck, Wigand |
  29. Priori, Alberto |
  30. Rossi, Símone |
  31. Rossini, P. M. |
  32. Rothwell, John C. |
  33. Rueger, Maria Adele |
  34. Ruffini, Giulio |
  35. Schellhorn, Klaus |
  36. Siebner, Hartwig Roman |
  37. Ugawa, Yoshikazu |
  38. Wexler, Anna |
  39. Ziemann, Ulf |
  40. Hallett, Mark |
  41. Paulus, Walter M. |
1000 Erscheinungsjahr 2017
1000 LeibnizOpen
1000 Publikationstyp
  1. Artikel |
1000 Online veröffentlicht
  • 2017-06-19
1000 Erschienen in
1000 Quellenangabe
  • 128(9):1774-1809
1000 FRL-Sammlung
1000 Copyrightjahr
  • 2017
1000 Verlagsversion
  • https://doi.org/10.1016/j.clinph.2017.06.001 |
  • https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5985830/ |
1000 Publikationsstatus
1000 Sprache der Publikation
1000 Abstract/Summary
  • Low intensity transcranial electrical stimulation (TES) in humans, encompassing transcranial direct current (tDCS), transcutaneous spinal Direct Current Stimulation (tsDCS), transcranial alternating current (tACS), and transcranial random noise (tRNS) stimulation or their combinations, appears to be safe. No serious adverse events (SAEs) have been reported so far in over 18,000 sessions administered to healthy subjects, neurological and psychiatric patients, as summarized here. Moderate adverse events (AEs), as defined by the necessity to intervene, are rare, and include skin burns with tDCS due to suboptimal electrode-skin contact. Very rarely mania or hypomania was induced in patients with depression (11 documented cases), yet a causal relationship is difficult to prove because of the low incidence rate and limited numbers of subjects in controlled trials. Mild AEs (MAEs) include headache and fatigue following stimulation as well as prickling and burning sensations occurring during tDCS at peak-to-baseline intensities of 1–2 mA and during tACS at higher peak-to-peak intensities above 2 mA. The prevalence of published AEs is different in studies specifically assessing AEs vs. those not assessing them, being higher in the former. AEs are frequently reported by individuals receiving placebo stimulation. The profile of AEs in terms of frequency, magnitude and type is comparable in healthy and clinical populations, and this is also the case for more vulnerable populations, such as children, elderly persons, or pregnant women. Combined interventions (e.g., co-application of drugs, electrophysiological measurements, neuroimaging) were not associated with further safety issues. Safety is established for low-intensity ‘conventional’ TES defined as <4 mA, up to 60 min duration per day. Animal studies and modeling evidence indicate that brain injury could occur at predicted current densities in the brain of 6.3–13 A/m2 that are over an order of magnitude above those produced by tDCS in humans. Using AC stimulation fewer AEs were reported compared to DC. In specific paradigms with amplitudes of up to 10 mA, frequencies in the kHz range appear to be safe. In this paper we provide structured interviews and recommend their use in future controlled studies, in particular when trying to extend the parameters applied. We also discuss recent regulatory issues, reporting practices and ethical issues. These recommendations achieved consensus in a meeting, which took place in Göttingen, Germany, on September 6–7, 2016 and were refined thereafter by email correspondence.
1000 Sacherschließung
lokal TES
lokal tACS
lokal tDCS
lokal safety
lokal adverse events
1000 Fächerklassifikation (DDC)
1000 Liste der Beteiligten
  1. https://frl.publisso.de/adhoc/creator/QW50YWwsIEFuZHJlYQ==|https://orcid.org/0000-0002-2205-4910|https://frl.publisso.de/adhoc/creator/Qmlrc29uLCBNYXJvbQ==|https://frl.publisso.de/adhoc/creator/QnJvY2ttw7ZsbGVyLCBKw7xyZ2Vu|https://orcid.org/0000-0002-6310-3571|https://frl.publisso.de/adhoc/creator/Q2hlbiwgUm9iZXJ0|https://frl.publisso.de/adhoc/creator/Q29oZW4sIExlb25hcmRvIEcu|https://frl.publisso.de/adhoc/creator/RG93dGh3YWl0ZSwgRy4=|https://frl.publisso.de/adhoc/creator/RWxscmljaCwgSmVucw==|https://frl.publisso.de/adhoc/creator/IEZsw7ZlbCwgQWduZXM=|https://frl.publisso.de/adhoc/creator/RnJlZ25pLCBGZWxpcGUgRi4=|https://frl.publisso.de/adhoc/creator/R2VvcmdlLCBNYXJrIFMu|https://frl.publisso.de/adhoc/creator/SGFtaWx0b24sIFJveSBILg==|https://orcid.org/0000-0003-3871-2890|https://orcid.org/0000-0003-0323-2272|https://frl.publisso.de/adhoc/creator/IEh1bW1lbCwgRnJpZWRoZWxt|https://frl.publisso.de/adhoc/creator/TGVmYXVjaGV1ciwgSmVhbi1QYXNjYWw=|https://frl.publisso.de/adhoc/creator/TGllYmV0YW56LCBEYXZpZA==|https://frl.publisso.de/adhoc/creator/TG9vLCBDb2xsZWVuIEsu|https://frl.publisso.de/adhoc/creator/TWNDYWlnLCBDb2xpbiBELg==|https://orcid.org/0000-0002-5436-4745|https://frl.publisso.de/adhoc/creator/TWlyYW5kYSwgUGVkcm8gQy4=|https://frl.publisso.de/adhoc/creator/TW9saWFkemUsIFZlcmE=|https://orcid.org/0000-0002-2207-5965|https://frl.publisso.de/adhoc/creator/Tm93YWssIFIu|https://frl.publisso.de/adhoc/creator/UGFkYmVyZywgRnJhbms=|https://frl.publisso.de/adhoc/creator/UGFzY3VhbC1MZW9uZSwgQWx2YXJv|https://frl.publisso.de/adhoc/creator/UG9wcGVuZGllY2ssIFdpZ2FuZA==|https://frl.publisso.de/adhoc/creator/UHJpb3JpLCBBbGJlcnRv|https://frl.publisso.de/adhoc/creator/Um9zc2ksIFPDrW1vbmU=|https://frl.publisso.de/adhoc/creator/Um9zc2luaSwgUC4gTS4=|https://frl.publisso.de/adhoc/creator/Um90aHdlbGwsIEpvaG4gQy4=|https://frl.publisso.de/adhoc/creator/IFJ1ZWdlciwgTWFyaWEgQWRlbGU=|https://frl.publisso.de/adhoc/creator/UnVmZmluaSwgR2l1bGlv|https://frl.publisso.de/adhoc/creator/U2NoZWxsaG9ybiwgS2xhdXM=|https://frl.publisso.de/adhoc/creator/U2llYm5lciwgSGFydHdpZyBSb21hbg==|https://frl.publisso.de/adhoc/creator/VWdhd2EsIFlvc2hpa2F6dQ==|https://frl.publisso.de/adhoc/creator/V2V4bGVyLCBBbm5h|https://frl.publisso.de/adhoc/creator/WmllbWFubiwgVWxm|https://frl.publisso.de/adhoc/creator/SGFsbGV0dCwgTWFyaw==|https://frl.publisso.de/adhoc/creator/UGF1bHVzLCBXYWx0ZXIgTS4=
1000 Hinweis
  • Preprint submitted to Clin Neurophysiol. Finally published in Clin Neurophysiol. 2017 Sep; 128(9): 1774–1809. https://doi.org/10.1016/j.clinph.2017.06.001
1000 Label
1000 Förderer
  1. German Federal Ministry for Education and Research |
  2. European Union |
  3. National Institutes of Health (NIH) |
  4. Labuschagne Foundation |
  5. National Institute of Neurological Disorders and Stroke (NINDS) |
1000 Fördernummer
  1. 01EE1403C, 01GQ1424E
  2. 686764
  3. R01NS101362-01, 1R01MH111896-01,1R01NS095123-01, 1R01MH109289-01
  4. -
  5. -
1000 Förderprogramm
  1. GCBS grant, TRAINSTIM grant
  2. FET program LUMINOUS
  3. -
  4. -
  5. -
1000 Dateien
  2. Open access options - Clinical Neurophysiology
    Open access options - Clinical Neurophysiology
1000 Förderung
  1. 1000 joinedFunding-child
    1000 Förderer German Federal Ministry for Education and Research |
    1000 Förderprogramm GCBS grant, TRAINSTIM grant
    1000 Fördernummer 01EE1403C, 01GQ1424E
  2. 1000 joinedFunding-child
    1000 Förderer European Union |
    1000 Förderprogramm FET program LUMINOUS
    1000 Fördernummer 686764
  3. 1000 joinedFunding-child
    1000 Förderer National Institutes of Health (NIH) |
    1000 Förderprogramm -
    1000 Fördernummer R01NS101362-01, 1R01MH111896-01,1R01NS095123-01, 1R01MH109289-01
  4. 1000 joinedFunding-child
    1000 Förderer Labuschagne Foundation |
    1000 Förderprogramm -
    1000 Fördernummer -
  5. 1000 joinedFunding-child
    1000 Förderer National Institute of Neurological Disorders and Stroke (NINDS) |
    1000 Förderprogramm -
    1000 Fördernummer -
1000 Objektart article
1000 Beschrieben durch
1000 @id frl:6413151.rdf
1000 Erstellt am 2019-02-28T16:34:50.720+0100
1000 Erstellt von 254
1000 beschreibt frl:6413151
1000 Bearbeitet von 317
1000 Zuletzt bearbeitet Mon Jan 08 11:59:02 CET 2024
1000 Objekt bearb. Mon Jan 08 11:59:01 CET 2024
1000 Vgl. frl:6413151
1000 Oai Id
  1. oai:frl.publisso.de:frl:6413151 |
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