Sheffield James G, Ramerpresad Sumientra, Brem Anna-Katharine, Mansfield Karen, Orhan Umut, Dillard Michael, McKanna James, Plessow Franziska, Thompson Todd, Santarnecchi Emiliano, Pascual-Leone Alvaro, Pavel Misha, Mathan Santosh, Cohen Kadosh Roi
Wellcome Centre for Integrative Neuroimaging, Department of Experimental Psychology, University of Oxford, United Kingdom.
Department of Electrical and Computer Engineering, Northeastern University, Boston, MA, USA.
Cortex. 2022 Sep;154:77-88. doi: 10.1016/j.cortex.2022.05.015. Epub 2022 Jun 14.
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.
随着经颅电刺激（tES）方案的不断发展，该技术背后的假设需要重新检验，以确保其仍然成立。虽然刺激的安全性主要在少数几次治疗以及小样本量的情况下得到了证实，但多次治疗后的不良事件（AE）在很大程度上仍未得到检验。同样，虽然通常认为盲法程序是有效的，但多次刺激治疗对盲法程序效果的影响也仍存在疑问。这在多中心项目中尤为重要，因为方案中微小的无意差异可能导致中心间的差异。我们报告了来自1019名参与者的不良事件和盲法数据，这些参与者在英国和美国的4个地点接受了多达11次半连续的有源或假经颅交流电刺激（tACS）、直流电刺激（tDCS）和随机噪声刺激（tRNS）治疗。我们发现，不良事件往往最好由tES以外的因素预测，如测试地点或治疗次数。盲法分析结果表明，tDCS和tACS的盲法效果不如tRNS。尽管使用了较小的电极或重复给药，但不良事件的发生似乎与tES无关。然而，在皮肤感觉较高的tES条件下，盲法效果受到影响，这凸显了对替代刺激盲法方案的需求。在希望进行更高强度刺激的研究中，这可能越来越有必要。
