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

• Published in: Clinical neurophysiology Vol. 128; no. 9; pp. 1774 - 1809
• Main Authors: Antal, A, Alekseichuk, I, Bikson, M, Brockmöller, J, Brunoni, A.R, Chen, R, Cohen, L.G, Dowthwaite, G, Ellrich, J, Flöel, 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, Paulus, W
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier B.V 01.09.2017
• Subjects: Adverse events; Animals; Brain - physiology; Burns, Electric - etiology; Burns, Electric - prevention & control; Humans; Neurology; Practice Guidelines as Topic - standards; Safety; tACS; tDCS; TES; Transcranial Direct Current Stimulation - adverse effects; Transcranial Direct Current Stimulation - ethics; Transcranial Direct Current Stimulation - standards; Repetitive Transcranial magnetic stimulation; Randomized clinical trial; TES; M1; Central nervous system; Code of Federal Regulations; Neuron specific enolase; HD-tDCS; MDD; PFC; Inferior frontal gyrus; transcranial direct current stimulation; Transcranial electrical stimulation; Temporoparietal junction; Magnetic resonance spectroscopy; N-Methyl-D-Aspartate; DBS; tRNS; safety; Deep Brain Stimulation; Vmem; Functional magnetic resonance imaging; EC; Food and Drug Administration; High-Definition tDCS; Major Depressive Disorder; EF; NSE; AC; AD; Alzheimer’s disease; AE; EEG; Adverse event; Do it yourself; MEG; Primary motor cortex; MAE; AR; fMRI; Direct Current; SAE; Alternating Current; MEP; Mini Mental State Examination; International Council on Harmonisation (before 2015: International Conference on Harmonisation); Probability Learning Task; transcutaneous spinal Direct Current Stimulation; FDA; PPC; RCT; tsDCS; tACS; CNS; Electroencephalography; Mild adverse event; IFG; transcranial alternating current stimulation; European Commission; CFR; MRS; TPJ; Dorsolateral prefrontal cortex; ONS; MMSE; Optic nerve stimulation; Serious adverse event; NMDA; PLT; Transmembrane potential; Posterior Parietal Cortex; Adverse reaction; Electroconvulsive therapy; Transcranial magnetic stimulation; DLPFC; Magnetoencephalography; adverse events; ICH; Prefrontal Cortex; Motor Evoked Potential; Electric field; PD; DIY; tDCS; ECT; TMS; rTMS; Parkinson’s disease; Transcranial random noise stimulation; DC; Adverse events; Safety
• ISSN: 1388-2457; 1872-8952
• DOI: 10.1016/j.clinph.2017.06.001

Highlights • The application of low intensity TES in humans appears to be safe. • The profile of AEs in terms of frequency, magnitude and type is comparable in different populations. • Structured checklists and interviews as recommended procedures are provided in this paper.