The goal of this pilot study is to describe a protocol for the remotely-supervised delivery of transcranial direct current stimulation (tDCS) so that the procedure maintains standards of in-clinic practice, including safety, reproducibility, and tolerability. The feasibility of this protocol was tested in participants with multiple sclerosis (MS).
Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation technique that uses low amplitude direct currents to alter cortical excitability. With well-established safety and tolerability, tDCS has been found to have the potential to ameliorate symptoms such as depression and pain in a range of conditions as well as to enhance outcomes of cognitive and physical training. However, effects are cumulative, requiring treatments that can span weeks or months and frequent, repeated visits to the clinic. The cost in terms of time and travel is often prohibitive for many participants, and ultimately limits real-world access.
Following guidelines for remote tDCS application, we propose a protocol that would allow remote (in-home) participation that uses specially-designed devices for supervised use with materials modified for patient use, and real-time monitoring through a telemedicine video conferencing platform. We have developed structured training procedures and clear, detailed instructional materials to allow for self- or proxy-administration while supervised remotely in real-time. The protocol is designed to have a series of checkpoints, addressing attendance and tolerability of the session, to be met in order to continue to the next step. The feasibility of this protocol was then piloted for clinical use in an open label study of remotely-supervised tDCS in multiple sclerosis (MS). This protocol can be widely used for clinical study of tDCS.
tDCS is a relatively recent therapy that operates through the use of low amplitude (2.0 mA or less) direct current to modulate cortical excitability 1. Hundreds of clinical trials have demonstrated tDCS to be safe and well-tolerated2-4. tDCS is easier to use, lower in cost, and better tolerated when compared to other methods such as transcranial magnetic stimulation (e.g., tDCS has not been associated with the development of seizures 5,6). Multiple tDCS sessions are required for benefit, especially when administered with the goal of enhancing rehabilitation outcomes.7-10
It is not yet known how many tDCS sessions are necessary or optimal, but the effects are cumulative with little evidence that tDCS over a single session produces behaviorally meaningful changes.2,11 For example, studies of depression have found 30 or more sessions needed for full benefit in some participants. 12,13 Multiple sessions are especially important when pairing tDCS with a behavioral therapy, which only occurs with rigorous repetition across many sessions. 14
For many patients and caregivers, traveling to the outpatient facility to receive repeated tDCS treatment sessions is a major obstacle in terms of time, cost and travel arrangements. This real-world limitation has resulted in studies with small sample sizes and without adequate power or design to draw conclusions that can lead to clinical use.15 Remote tDCS delivery would allow for participation in study protocols from home or other locations, and reach those patients who otherwise would not have access to these trials. Further, it allows the possibility for testing “on-demand” application for indications such as epilepsy and migraines.
We have worked with a diverse group of clinical investigators interested in remotely-supervised tDCS to develop guidelines and standards for remotely-supervised tDCS delivery including specialized equipment and specific training requirements both for staff and study participants16. Here, we developed a protocol to follow these guidelines and test for feasibility in patients with multiple sclerosis (MS), a disorder where tDCS may be a useful tool for the management of its symptoms. 11,17-23
在协议中的关键步骤
由于远程监督TDCS是从一个临床医生,入选和排除标准的设计直接监督管理的路程,以保证参与者有没有禁忌的健康状况或环境的干扰,并且完全有能力使用一台笔记本电脑(包括自适应技术),用于研究小组沟通。此外,参加者必须能够忍受TDCS会议,并提交到预定的会议时间学习的时间。
而远程TDCS提供方便的治疗的研究和管理,自导参与者使用是不可取的,由于双方的安全问题以及无法监视和标准化所递送的刺激。相反,我们的协议遵循的标准和准则进行远程监督TDCS 16延长CL通过交付在偏远地区INIC标准。该准则确保科研人员经过适当培训的学员的互动,使用户有机会参加远程TDCS适当的能力,并有持续的培训材料,以及在研究的每个步骤中的参与者的评估。刺激是一致的和可重复使用的1.5毫安整整20分钟,在每一个会议上发表,而不需要通过会话或个人的任何中断或变化。
修改协议和故障排除提示
该协议包括一些小的修改。首先,我们扩大了使用这种协议来MS参与者有一个EDSS评分超过6.5在有访问管理每个剂量的代理实例。此外,我们还实施了一项程序,使我们远程访问参加者提供学习的笔记本电脑发起网络confe伦斯为那些谁需要耐受性的额外支持和审查措施,并通过一个共享的文件学习经验。未来的修改目前的协议包括允许不同程度的远程监控,使参与者证明谁最有能力的技术将只需要初期督导,以确认设备的设置和接收解锁代码。
该技术的局限性
虽然我们的初步研究结果支持该协议的可行性,样本大小是有限的。作为注册的扩展,分析将被用于在训练间隙制成,如何简化会话,增强教学视频,和使该技术更容易获得那些具有运动功能障碍(即,自适应老鼠计算机使用中,海绵的口袋/耳机修改以进一步缓解应用程序)。在EDSS一些与会者的范围低于6.5(不需要代理),可能还是会遇到一些DIFficulty在耳机的准备和故障排除的计算机相关的问题。此外,虽然这项研究建议在所有会话完整的远程监控的参与者,未来的研究可能会认为一些与会者充分的训练来操作设备,而无需监管对话的全部内容。
该方法相对于现有方法的意义
这些初步结果表明我们的协议进行远程监督TDCS交付的临床试验,下面的一组指导原则和标准,必须采用安全的可行性,并有效地管理远程监督下TDCS。该协议被设计为具有决策树一系列关卡以“停止”的准则(上文2.5.1节),必须以继续在每一步被清除(见图1)。这些检查点解决痛苦或不良反应的耐受性(经验s到治疗)及合规(及时的会议出席率和适当的技术)。对于每个会话1到10,参与者完成简短的不良事件报告前,他们的课程后(与在以前的试验中最常见的TDCS的副作用列表导出项目)。此外,与会者完成了自我报告的措施来解决耐受性(之前和之后的会议),并可以完成症状库存为好。这项研究是在它建立了一个技术审查MS疗法提供足够的功率,同时也提供了一个TDCS处理更广泛的访问显著。
该技术的未来应用
一旦方法进行远程监督TDCS已在MS人群得到了充分的驾驶,更大规模,随机对照试验,可以发起针对症状的管理。通过使用教学培训材料和结构周围的日常参与者INTERActions,远程监督TDCS可以通过更广泛的患者人群进行访问,并扩大该技术的临床研究。
The authors have nothing to disclose.
Supported by The Lourie Foundation, Inc.
Mini-CT transcranial direct current stimulation device | Soterix | Device to deliver direct current stimultion in a remote manner | |
Study Kit | NA | Provided to participant with all required setup items – device, headset, sponge pockets, pre-filled syringes, Kleenex, handheld mirro, spare batteries | |
Laptop | NA | Provided to allow secure video conferecing during device setup and headset placement | |
Instruction Manual | NA | Transcription of instructional video and detailed instructions for protocol |