Differences in the experience of active and sham transcranial direct current stimulation.

Differences in the experience of active and sham transcranial direct current stimulation.
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DOI:
10.1016/j.brs.2011.02.007
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发表时间:
2012-04
期刊:
影响因子:
7.7
通讯作者:
Hamilton, Roy H.
Hamilton, Roy H.
中科院分区:
医学1区
文献类型:
--
作者:
Kessler, Sudha Kilaru;Turkeltaub, Peter E.;Benson, Jennifer G.;Hamilton, Roy H.

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有限数量的研究表明,使用经颅直流电刺激(tDCS)调节皮质兴奋性是安全和可耐受的。很少有人直接评估假刺激和主动刺激是否无法区分。我们的目的是证明tDCS的安全性和耐受性在一个大的队列,并比较假刺激和积极刺激会话之间的副作用的发生率和严重程度。接受277次tDCS治疗的131名健康受试者在刺激期间和刺激后对副作用的感知进行1至5级评分。使用Fisher精确检验比较与副作用相关的活性和假治疗的比例,使用Kruskal-Wallis检验比较严重程度等级的分布。未发生严重不良反应。最常见的副作用是刺痛(76%),瘙痒(68%),灼热(54%)和疼痛(25%)。副作用的严重程度是轻微的,只有不到2%的反应表明在刺激期间除了刺痛(15%)、瘙痒(20%)、烧灼感(7%)、疼痛(5%)和疲劳(3%)之外的所有问题的严重程度>3。与假手术组相比,主动刺激组的感觉副作用发生率在统计学上显著更高。其他刺激参数对副作用发生率无统计学显著影响。TDCS是一种安全、耐受性良好的技术,没有证据表明存在严重不良反应的风险。感官副作用很常见,但严重程度通常很低。由于与假tDCS相比,主动刺激的感觉副作用更频繁且更严重,因此目前的假刺激方法可能不是某些研究的适当对照条件。
A limited number of studies have shown that modulation of cortical excitability using transcranial direct current stimulation (tDCS) is safe and tolerable. Few have directly evaluated whether sham and active stimulation are indistinguishable. We aimed to demonstrate tDCS safety and tolerability in a large cohort, and to compare the occurrence and severity of side effects between sham and active stimulation sessions. 131 healthy subjects undergoing 277 tDCS sessions rated on a 1 to 5 scale the perception of side effects during and after stimulation. Proportions of active and sham sessions associated with side effects were compared using Fisher’s exact test, and distributions of severity ratings were compared using the Kruskal-Wallis test. No serious adverse effects occurred. Side effects most commonly reported were tingling (76%), itching (68%), burning (54%), and pain (25%). Side effect severity was mild, with fewer than two percent of responses indicating a severity >3 on all questions except tingling (15%), itching (20%), burning (7%), pain (5%) and fatigue (3%) during stimulation. Rates of sensory side effects were statistically significantly higher in active stimulation sessions compared to sham sessions. No other stimulation parameters had a statistically significant impact on side effect occurrence. TDCS is a safe well-tolerated technique with no evidence of risk for serious adverse effects. Sensory side effects are common, but the severity is typically low. Because sensory side effects are more frequent and more severe in active compared to sham tDCS, the current method of sham stimulation may not be an adequate control condition for some studies.
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