PMID- 35759817 OWN - NLM STAT- MEDLINE DCOM- 20220830 LR - 20220927 IS - 1973-8102 (Electronic) IS - 0010-9452 (Linking) VI - 154 DP - 2022 Sep TI - Blinding efficacy and adverse events following repeated transcranial alternating current, direct current, and random noise stimulation. PG - 77-88 LID - S0010-9452(22)00162-9 [pii] LID - 10.1016/j.cortex.2022.05.015 [doi] AB - As transcranial electrical stimulation (tES) protocols advance, assumptions underlying the technique need to be retested to ensure they still hold. Whilst the safety of stimulation has been demonstrated mainly for a small number of sessions, and small sample size, adverse events (AEs) following multiple sessions remain largely untested. Similarly, whilst blinding procedures are typically assumed to be effective, the effect of multiple stimulation sessions on the efficacy of blinding procedures also remains under question. This is especially relevant in multisite projects where small unintentional variations in protocol could lead to inter-site difference. We report AE and blinding data from 1,019 participants who received up to 11 semi-consecutive sessions of active or sham transcranial alternating current stimulation (tACS), direct current stimulation (tDCS), and random noise stimulation (tRNS), at 4 sites in the UK and US. We found that AEs were often best predicted by factors other than tES, such as testing site or session number. Results from the blinding analysis suggested that blinding was less effective for tDCS and tACS than tRNS. The occurrence of AEs did not appear to be linked to tES despite the use of smaller electrodes or repeated delivery. However, blinding efficacy was impacted in tES conditions with higher cutaneous sensation, highlighting a need for alternative stimulation blinding protocols. This may be increasingly necessary in studies wishing to deliver stimulation with higher intensities. CI - Copyright (c) 2022 The Author(s). Published by Elsevier Ltd.. All rights reserved. FAU - Sheffield, James G AU - Sheffield JG AD - Wellcome Centre for Integrative Neuroimaging, Department of Experimental Psychology, University of Oxford, United Kingdom. FAU - Ramerpresad, Sumientra AU - Ramerpresad S AD - Department of Electrical and Computer Engineering, Northeastern University, Boston, MA, USA. FAU - Brem, Anna-Katharine AU - Brem AK AD - University Hospital of Old Age Psychiatry, University of Bern, Bern, Switzerland; Department of Old Age Psychiatry, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, United Kingdom. FAU - Mansfield, Karen AU - Mansfield K AD - Department of Psychiatry, University of Oxford, Oxford, UK. FAU - Orhan, Umut AU - Orhan U AD - Honeywell Labs, Honeywell Aerospace, Redmond, WA, USA. FAU - Dillard, Michael AU - Dillard M AD - Honeywell Labs, Honeywell Aerospace, Redmond, WA, USA. FAU - McKanna, James AU - McKanna J AD - Department of Electrical and Computer Engineering, Northeastern University, Boston, MA, USA. FAU - Plessow, Franziska AU - Plessow F AD - Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA. FAU - Thompson, Todd AU - Thompson T AD - Department of Brain and Cognitive Sciences, Massachusetts Institute of Technology, Cambridge, MA, USA. FAU - Santarnecchi, Emiliano AU - Santarnecchi E AD - Berenson-Allen Center for Noninvasive Brain Stimulation and Division for Cognitive Neurology, Department of Neurology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA. FAU - Pascual-Leone, Alvaro AU - Pascual-Leone A AD - Berenson-Allen Center for Noninvasive Brain Stimulation and Division for Cognitive Neurology, Department of Neurology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA. FAU - Pavel, Misha AU - Pavel M AD - Department of Electrical and Computer Engineering, Northeastern University, Boston, MA, USA. FAU - Mathan, Santosh AU - Mathan S AD - Honeywell Labs, Honeywell Aerospace, Redmond, WA, USA. FAU - Cohen Kadosh, Roi AU - Cohen Kadosh R AD - School of Psychology, University of Surrey, Guildford, UK. Electronic address: r.cohenkadosh@surrey.ac.uk. LA - eng GR - WT_/Wellcome Trust/United Kingdom PT - Journal Article PT - Research Support, Non-U.S. Gov't PT - Research Support, U.S. Gov't, Non-P.H.S. DEP - 20220614 PL - Italy TA - Cortex JT - Cortex; a journal devoted to the study of the nervous system and behavior JID - 0100725 SB - IM MH - Humans MH - Sensation MH - Skin MH - *Transcranial Direct Current Stimulation OTO - NOTNLM OT - Adverse events OT - Blinding efficacy OT - Multisite recording OT - Transcranial electric stimulation COIS- Declaration of competing interest Alvaro Pascual-Leone serves on the scientific advisory boards for Starlab Neuroscience, Neuroelectrics, Constant Therapy, Cognito, and Neosync; and is listed as an inventor on several issued and pending patents on the real-time integration of transcranial magnetic stimulation (TMS) with electroencephalography (EEG) and magnetic resonance imaging (MRI). Roi Cohen Kadosh serves on the scientific advisory boards for Neuroelectrics and Innosphere, and is the founder, director and shareholder of Cognite Neurotechnology and listed as an inventor on a pending patent that allows personalisation of neuromodulation. There are no other known conflicts of interest associated with this publication and there has been no significant financial support for this work that could have influenced its outcome. EDAT- 2022/06/28 06:00 MHDA- 2022/08/31 06:00 CRDT- 2022/06/27 18:13 PHST- 2021/10/10 00:00 [received] PHST- 2022/04/10 00:00 [revised] PHST- 2022/05/03 00:00 [accepted] PHST- 2022/06/28 06:00 [pubmed] PHST- 2022/08/31 06:00 [medline] PHST- 2022/06/27 18:13 [entrez] AID - S0010-9452(22)00162-9 [pii] AID - 10.1016/j.cortex.2022.05.015 [doi] PST - ppublish SO - Cortex. 2022 Sep;154:77-88. doi: 10.1016/j.cortex.2022.05.015. Epub 2022 Jun 14.