Antal, A., Alekseichuk, I., Bikson, M., Brockmoeller, J., Brunoni, A. R., Chen, R., Cohen, L. G., Dowthwaite, G., Ellrich, J., Floeel, A., Fregni, F., George, M. S., Hamilton, R., Haueisen, J., Herrmann, C. S., Hummel, F. C., Lefaucheur, J. P., Liebetanz, D., Loo, C. K., McCaig, C. D., Miniussi, C., Miranda, P. C., Moliadze, V., Nitsche, M. A., Nowak, R., Padberg, F., Pascual-Leone, A., Poppendieck, W., Priori, A., Rossi, S., Rossini, P. M., Rothwell, J., Rueger, M. A., Ruffini, G., Schellhorn, K., Siebner, H. R., Ugawa, Y., Wexler, A., Ziemann, U., Hallett, M. and Paulus, W. (2017). Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines. Clin. Neurophysiol., 128 (9). S. 1774 - 1810. CLARE: ELSEVIER IRELAND LTD. ISSN 1872-8952

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Abstract

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.& para;& para;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.& para;& para;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 Afin(2) 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.& para;& para;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 Gottingen, Germany, on September 6-7, 2016 and were refined thereafter by email correspondence. (C) 2017 International Federation of Clinical Neurophysiology. Published by Elsevier Ireland Ltd. All rights reserved.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Antal, A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Alekseichuk, I.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bikson, M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Brockmoeller, J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Brunoni, A. R.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Chen, R.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Cohen, L. G.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Dowthwaite, G.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ellrich, J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Floeel, A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fregni, F.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
George, M. S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hamilton, R.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Haueisen, J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Herrmann, C. S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hummel, F. C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lefaucheur, J. P.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Liebetanz, D.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Loo, C. K.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
McCaig, C. D.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Miniussi, C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Miranda, P. C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Moliadze, V.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Nitsche, M. A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Nowak, R.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Padberg, F.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Pascual-Leone, A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Poppendieck, W.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Priori, A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rossi, S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rossini, P. M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rothwell, J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rueger, M. A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ruffini, G.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schellhorn, K.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Siebner, H. R.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ugawa, Y.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wexler, A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ziemann, U.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hallett, M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Paulus, W.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-220666
DOI: 10.1016/j.clinph.2017.06.001
Journal or Publication Title: Clin. Neurophysiol.
Volume: 128
Number: 9
Page Range: S. 1774 - 1810
Date: 2017
Publisher: ELSEVIER IRELAND LTD
Place of Publication: CLARE
ISSN: 1872-8952
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
ALTERNATING-CURRENT STIMULATION; NONINVASIVE BRAIN-STIMULATION; DORSOLATERAL PREFRONTAL CORTEX; RANDOM NOISE STIMULATION; RETINAL GANGLION-CELLS; MAGNETIC STIMULATION; MOTOR CORTEX; DOUBLE-BLIND; CEREBRAL-PALSY; DC STIMULATIONMultiple languages
Clinical Neurology; NeurosciencesMultiple languages
Refereed: Yes
URI: http://kups.ub.uni-koeln.de/id/eprint/22066

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