Remotely-supervised transcranial direct current stimulation (tDCS) for clinical trials: guidelines for technology and protocols.
Remotely-supervised transcranial direct current stimulation (tDCS) for clinical trials: guidelines for technology and protocols.
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DOI：
10.3389/fnsys.2015.00026
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发表时间：
2015
影响因子：
3
通讯作者：
Bikson M
中科院分区：
文献类型：
--
作者：
Charvet LE;Kasschau M;Datta A;Knotkova H;Stevens MC;Alonzo A;Loo C;Krull KR;Bikson M
经颅直流电刺激（tDCS）的效果是累积的。治疗方案通常需要持续数周或数月的多次连续治疗。然而，前往诊所进行tDCS会话可能会给受试者及其护理人员带来障碍。通过改进设备和头套，tDCS治疗可以在临床监督下远程实施，可能会增加招募、吞吐量和便利性。在这里，我们提出了使用远程监督tDCS的临床试验的标准和方案，目的是在临床之外提供安全、可重复和耐受性良好的刺激治疗。建议包括：(1)对工作人员进行tDCS治疗和监督方面的培训；(2)评估用户远程参与tDCS的能力；(3)持续的培训程序和材料，包括对使用者和/或护理人员的评估；(4)简单、安全的电极制备技术和tDCS头套；（五）严格控制每一疗程的剂量；(6)持续监测以量化依从性（器械制备、电极饱和/放置、刺激方案），并按要求采取相应的纠正措施；(7)监测治疗后出现的不良反应；(8)终止治疗和/或研究参与的指导方针，包括根据治疗人群的需要水平量身定制的紧急故障安全程序。这些指南旨在为寻求在专业治疗中心以外应用tDCS的临床试验提供最低程度的方法学严谨性。根据这些建议，我们概述了特定适应症的应用（注意缺陷多动障碍、抑郁症、多发性硬化症、姑息治疗），这些建议支持评估远程监督tDCS的耐受性和可重复性的标准化框架，一旦建立，将允许将tDCS临床试验转化为更大规模和范围的患者群体。
The effect of transcranial direct current stimulation (tDCS) is cumulative. Treatment protocols typically require multiple consecutive sessions spanning weeks or months. However, traveling to clinic for a tDCS session can present an obstacle to subjects and their caregivers. With modified devices and headgear, tDCS treatment can be administered remotely under clinical supervision, potentially enhancing recruitment, throughput, and convenience. Here we propose standards and protocols for clinical trials utilizing remotely-supervised tDCS with the goal of providing safe, reproducible and well-tolerated stimulation therapy outside of the clinic. The recommendations include: (1) training of staff in tDCS treatment and supervision; (2) assessment of the user’s capability to participate in tDCS remotely; (3) ongoing training procedures and materials including assessments of the user and/or caregiver; (4) simple and fail-safe electrode preparation techniques and tDCS headgear; (5) strict dose control for each session; (6) ongoing monitoring to quantify compliance (device preparation, electrode saturation/placement, stimulation protocol), with corresponding corrective steps as required; (7) monitoring for treatment-emergent adverse effects; (8) guidelines for discontinuation of a session and/or study participation including emergency failsafe procedures tailored to the treatment population’s level of need. These guidelines are intended to provide a minimal level of methodological rigor for clinical trials seeking to apply tDCS outside a specialized treatment center. We outline indication-specific applications (Attention Deficit Hyperactivity Disorder, Depression, Multiple Sclerosis, Palliative Care) following these recommendations that support a standardized framework for evaluating the tolerability and reproducibility of remote-supervised tDCS that, once established, will allow for translation of tDCS clinical trials to a greater size and range of patient populations.