Buchanan Derrick M, Amare Sarah, Gaumond Genevieve, D'Angiulli Amedeo, Robaey Philippe
Department of Neuroscience, Carleton University, Ottawa, ON K1S 5B6, Canada.
Neuroscience of Imagination Cognition Emotion Research Lab, Carleton University, Ottawa, ON K1S 5B6, Canada.
J Clin Med. 2023 Jun 28;12(13):4346. doi: 10.3390/jcm12134346.
Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique with substantial evidence for its safety and tolerability in adults. However, less than 5% of published tDCS research is in pediatrics. Our primary objective was to investigate tDCS safety, tolerability, and acceptability in a sample of children and adults. We hypothesized that children and adults would be equal with regard to tDCS safety, tolerability, and acceptability. We tested this hypothesis using a Bayesian approach. Sixty participants aged 6-45 (balanced for sex) participated in a randomized double-blind controlled trial. They were randomly assigned to two ten-minute tDCS sessions with varying amperages and electrode locations. The primary outcome measure of this study was the intensity of 13 potential side effects evaluated at six different time points spanning two weeks. Independent sample Bayes factor tests were conducted between children/adults, males/females, clinical/healthy, and low/high amperage groups. As predicted, there was moderate support for the null hypothesis in all between-group analyses. There were no serious adverse events or dropouts, and the number needed to treat for an additional harmful outcome was 23. This study provided evidence supporting the overall short-term safety, tolerability, and acceptability of tDCS including amperages up to 2 mA and different electrode placements.
经颅直流电刺激（tDCS）是一种非侵入性脑刺激技术，在成人中其安全性和耐受性有大量证据支持。然而，已发表的tDCS研究中儿科研究不到5%。我们的主要目标是在儿童和成人样本中研究tDCS的安全性、耐受性和可接受性。我们假设儿童和成人在tDCS安全性、耐受性和可接受性方面是等同的。我们使用贝叶斯方法检验了这一假设。60名年龄在6至45岁（性别均衡）的参与者参加了一项随机双盲对照试验。他们被随机分配到两个为期十分钟的tDCS疗程，电流强度和电极位置各不相同。本研究的主要结局指标是在两周内六个不同时间点评估的13种潜在副作用的强度。在儿童/成人、男性/女性、临床/健康以及低/高电流强度组之间进行了独立样本贝叶斯因子检验。如预期的那样，在所有组间分析中对零假设都有适度支持。没有严重不良事件或退出情况，额外出现有害结局的治疗所需人数为23。本研究提供了证据支持tDCS的总体短期安全性、耐受性和可接受性，包括高达2 mA的电流强度和不同的电极放置。
