Siena Brain Investigation & Neuromodulation Lab (Si-BIN Lab), Department of Medicine, Surgery and Neuroscience, Neurology and Clinical Neurophysiology Section, University of Siena, Italy.
Section of Psychology, Department of Neuroscience, Psychology, Drug Research, Child Health, University of Florence, Florence, Italy.
Brain Stimul. 2020 Mar-Apr;13(2):507-516. doi: 10.1016/j.brs.2019.11.004. Epub 2019 Nov 9.
Transcranial direct current stimulation (tDCS), a non-invasive brain stimulation technique able to transiently modulate brain activity, is surging as one of the most promising therapeutic solutions in many neurological and psychiatric disorders. However, profound limitations exist in current placebo (sham) protocols that limit single- and double-blinding, especially in non-naïve subjects.
To ensure better blinding and strengthen reliability of tDCS studies and trials, we tested a new optimization algorithm aimed at creating an "active" sham tDCS condition (ActiSham hereafter) capable of inducing the same scalp sensations perceived during real stimulation while preventing currents from reaching the cortex and cause changes in brain excitability.
A novel model-based multielectrode technique - optimizing the location and currents of a set of small electrodes placed on the scalp - was used to control the relative amount of current delivered transcranially in real and placebo multichannel tDCS conditions. The presence, intensity and localization of scalp sensations during tDCS was evaluated by means of a specifically designed questionnaire administered to the participants. We compared blinding ratings by directly addressing subjects' ability to discriminate across conditions for both traditional (Bifocal-tDCS and Sham, using sponge electrodes) and our novel multifocal approach (both real Multifocal-tDCS and ActiSham). Changes in corticospinal excitability were monitored based on Motor Evoked Potentials (MEPs) recorded via concurrent Transcranial Magnetic Stimulation (TMS) and electromyography (EMG).
Participants perceived Multifocal-tDCS and ActiSham similarly in terms of both localization and intensity of scalp sensations, whereas traditional Bifocal stimulation was rated as more painful and annoying compared to its Sham counterpart. Additionally, differences in scalp localization were reported for active/sham Bifocal-tDCS, with Sham tDCS inducing more widespread itching and burning sensations. As for MEPs amplitude, a main effect of stimulation was found when comparing Bifocal-Sham and ActiSham (F = 6.67, p = .023), with higher MEPs amplitudes after the application of Bifocal-Sham.
Compared to traditional Bifocal-tDCS, ActiSham offers better participants' blinding by inducing very similar scalp sensations to those of real Multifocal tDCS both in terms of intensity and localization, while not affecting corticospinal excitability.
经颅直流电刺激(tDCS)是一种非侵入性脑刺激技术,能够短暂调节大脑活动,作为许多神经和精神疾病的最有前途的治疗方法之一而备受关注。然而,目前的安慰剂(假)方案存在深刻的局限性,限制了单盲和双盲,特别是在非新手受试者中。
为了确保更好的盲法并加强 tDCS 研究和试验的可靠性,我们测试了一种新的优化算法,旨在创建一种能够产生与真实刺激时相同的头皮感觉的“主动”假 tDCS 条件(简称 ActiSham),同时防止电流到达皮层并引起大脑兴奋性的变化。
一种新的基于模型的多电极技术——优化放置在头皮上的一组小电极的位置和电流——用于控制真实和安慰剂多通道 tDCS 条件下经颅传递的电流相对量。通过专门设计的问卷评估参与者在 tDCS 期间头皮感觉的存在、强度和定位。我们通过直接针对受试者在两种传统方法(双焦点 tDCS 和使用海绵电极的假刺激)和我们的新多焦点方法(真实多焦点 tDCS 和 ActiSham)之间进行区分的能力来比较盲法评价。通过同时进行经颅磁刺激(TMS)和肌电图(EMG)记录来监测皮质脊髓兴奋性的变化。
参与者在头皮感觉的定位和强度方面对多焦点 tDCS 和 ActiSham 的感觉相似,而传统的双焦点刺激与假刺激相比被评为更痛苦和烦人。此外,主动/假双焦点 tDCS 的头皮定位也存在差异,假刺激引起更广泛的瘙痒和烧灼感。至于 MEPs 幅度,在比较双焦点-Sham 和 ActiSham 时发现了刺激的主要效应(F=6.67,p=0.023),双焦点-Sham 后 MEPs 幅度更高。
与传统的双焦点 tDCS 相比,ActiSham 通过在强度和定位方面产生与真实多焦点 tDCS 非常相似的头皮感觉,同时不影响皮质脊髓兴奋性,为参与者提供了更好的盲法。