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. 2022 Sep:154:77-88.
doi: 10.1016/j.cortex.2022.05.015. Epub 2022 Jun 14.

Blinding efficacy and adverse events following repeated transcranial alternating current, direct current, and random noise stimulation

James G Sheffield  1 , Sumientra Ramerpresad  2 , Anna-Katharine Brem  3 , Karen Mansfield  4 , Umut Orhan  5 , Michael Dillard  5 , James McKanna  2 , Franziska Plessow  6 , Todd Thompson  7 , Emiliano Santarnecchi  8 , Alvaro Pascual-Leone  8 , Misha Pavel  2 , Santosh Mathan  5 , Roi Cohen Kadosh  9
Affiliations
Free article

Blinding efficacy and adverse events following repeated transcranial alternating current, direct current, and random noise stimulation

James G Sheffield et al. Cortex. 2022 Sep.
Free article

Abstract

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.

Keywords: Adverse events; Blinding efficacy; Multisite recording; Transcranial electric stimulation.

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Conflict of interest statement

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.

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