Name: a protocol for the use of remotely-supervised transcranial direct current stimulation (tdcs) in multiple sclerosis (ms)
Uploaded: 2015-12-26T13:00:00.000+00:00
Duration: 8 min 18 s
Description: Watch this Scientific Journal Video about A Protocol for the Use of Remotely-Supervised Transcranial Direct Current Stimulation tDCS in Multiple Sclerosis MS at JoVE.com

Supported by The Lourie Foundation, Inc.

伦理声明:纽约州立石溪大学的机构审查委员会（IRB）批准了该协议于2015年2月10日。 1.参加者招募的远程监督TDCS的<ol><li>提供招募研究参与者与设备上的信息十天研究协议。 </li></ol> 2.包含/排除标准<ol><li>健康<ol><li>确保临床医生已经在基线访问所有登记的与会者提供体检合格证明。 </li></ol></li><li> TDCS耐受性和笔记本电脑资质<ol><li>确保参与者所熟悉的一台笔记本电脑的基本功能，以及如何将计算机连接到Wi-Fi网络。对于这两种使用笔记本电脑，而TDCS设备的设置，确保参与者（或代理），有灵巧来完成的过程。 </li><li>除了设置，在基线参观，让参与者1.5 1分钟试验剂量TDCS毫安确定的耐受性。如果参与者不能忍受这种会议，为1.0 mA的低剂量可以应用。如果没有容忍，排除参与者。 </li></ol></li><li>环境的<ol><li>确认参与者有机会获得分心自由，光线充足，整洁的环境与安全区来存储设备和设备套件。 </li></ol></li><li>合规<ol><li>如果参与者不符合预定的视频会议会话及时，排除参与者。 </li></ol></li><li>停止标准<ol><li>在每个参与者的互动，审查了一系列的规定"停止标准"，以确保参与者容忍的会议，坚持学习进度和安全操作设备无不良影响。应任何这些得到满足，排除在研究参与者（图1）。 </li></ol></li></ol> 3.材料注意:至于建议中的远程监督使用16的出版方针，精确的电极的制备和位置必须反映该诊所的协议相对于剂量的控制和持续监控。 <ol><li>设备工具包<ol><li>准备每个远程TDCS参与者相同的材料。这包括提供研究膝上型计算机与安全的视频会议软件，装置，和一个装置套件。 </li><li>设计该装置套件的易用性和白天组织它（图2）。 </li><li>制备具有大小5x5cm的带穿孔20裹海绵的口袋的试剂盒的顶部（每所需的10天的研究天），20注射器预填充用6mL的每个海绵的口袋的盐溶液，用洗瓶填充有额外的盐，备用电池的设备，以及手持镜子耳机应用。 </li><li>此外，需要研究用户拥有便携式家用电话或移动电话的工作区为每会话。 </li></ol></li><li>设备<ol><li>选择，只有通过一个一次性使用的解锁码释放会话的TDCS设备。确保研究设备具有这样一种功能后研究的技术人员所提供的代码，参与者只能管理一个会话。此外，确保在研究设备的选择，接触质量不断监测，以确保安全和正常使用。 </li></ol></li><li>视频监控<ol><li>选择一个安全的视频会议软件，以便设备，最佳的接触质量的正确安装的远程监控，并且所需的用户正在应用的会话。 </li><li>使用视频会议软件作为培训的另一种方法。指导用户如何打开设备，阅读他们的接触质量，排除接触质量差，输入一个一次性使用的解锁码，并且关机后安全地删除该设备。 </li></ol></li><li>帽子<ol><li>设计头饰的SIM卡PLE和强大的电极定位。使用单位头饰消除房间的用户错误，并帮助节省了放置蒙太奇。配置一个帽状设计，具有明确标明海绵标记以加强与所述阳极电极放置在左侧的单位置头套放置的可靠性。 </li></ol></li></ol> 4.培训注:远程研究的第一基准会议期间完成大部分参与者的培训。大约1-2小时的基线访问应该花在培训。让参与者观看一个教学TDCS视频作为自己的第一个指令。 <ol><li>教学视频<ol><li>建立教学视频下面的基线访发挥的参与者。在观看，允许参与者能够访问该设备和装置套件，并跟随在每一个步骤。 </li><li>准备先介绍particip视频蚂蚁的材料，然后过渡到一个一步一步的指导，模仿实际的学习会的流程。 </li><li>目前TDCS耳机缓慢而清晰的设置（并使其可用于重播），如果用户需要澄清。还提供了一个参与视图，使这项研究的参与者能够获得什么样的设备屏幕期望，以及如何提供一定的读数时，该设备显示将出现感。 </li></ol></li><li>视频部分 注:远程技术人员不会为设备提供解锁代码，除非适当的接触质量的实现。 <ol><li>设计教学视频细节故障排除联系信息质量差，包括施加压力和润湿海绵口袋的手段。确保视频还提供了学习材料的安全使用信息，以及该协议，以结束会话跟踪。 </li><li>指导有关程序与会者终止会话，并要求看齐ticipants保持在整个会话期间电话接入，保证在诊所安全保持在紧急情况下的电平， </li><li>之后的视频，允许参与者以尝试自己的一套与一个研究的技术人员的帮助。 </li></ol></li><li>使用手册<ol><li>准备在视频呈现的信息，以及照片和材料的图，装置的屏幕截图，和笔记本电脑的信息的转录，在手动的形式。 </li></ol></li><li>现场培训<ol><li>监视参与者，因为他们开始菜单。 </li><li>完成每个步骤（滋润海绵口袋，将电极浸入海绵，海绵固定到耳机，耳机的地方头部，中心头戴式耳机，确认研究的技术人员，并打开设备）教练参加。 </li><li>澄清过程或设备在必要。 </li></ol></li><li>与会者那段经历一系列故障排除向上难度<ol><li>如果参与者奋斗与设置，重复该方法的示范。 </li><li>如果参与者未能完成组建经过反复尝试，终止会话。这被定义为一个研究"停"的标准。 </li></ol></li></ol> 5.参与者准备学习会议<ol><li>指导参与者建立自己的研究笔记本电脑，移动电话，设备工具包，设备和耳机在干净，照明良好的区域。与会者通报拉头发向后，尽量减少干扰。 </li><li>让参与者指的是教学视频或手动一步协议的步骤指南。 </li><li>首先启动网络会议开头的设置，以便有持续监测遵守16前的研究参与者。 </li></ol>在学习会话6.设备安装<ol><li>启动视频会议结束后，指示参与者开始集U页。 </li><li>打开海绵口袋和滋润使用6毫升注射器（每个海绵口袋一个针筒）。约3毫升可用于润湿海绵的口袋的每一侧。 </li><li>应用碳橡胶电极进行电流从TDCS刺激。包住海绵口袋里的电极。将每个碳橡胶电极插入海绵的口袋里完全。注:由于橡胶电极直接接触皮肤是痛苦的，电极，装在口袋里的海绵。 </li><li>确保红色电缆连接到设备上标有"阳极"红色接收器插件。确保黑色电缆连接到设备上标有"阴极"黑接收器插件。这些电缆是永远不会从设备中删除。 </li><li>连接海绵的口袋和电极的耳机使用公共双边背外侧前额叶皮质（DLPC），与设置在左侧的阳极电极（一个连接到红色线）。注:标注耳机与红色和黑色，以确保适当的电极放置。 </li><li>使用固定在海绵上的口袋适合插入耳机槽按钮耳机。海绵口袋光滑的一面总是朝向朝前额。 注意:此提供方便可靠的电极放置和广泛的治疗应用。 </li><li>后海绵的口袋被紧固，定位在头上的耳机。掖在头部背面的槽下方的背带，并与鼻根对准中央按钮。这可以通过在设备工具包，并通过视频会议软件的研究技术人员提供的手持镜子确认。 </li><li>在这一点上，指示参与者朗读设备屏幕上的接触质量。注:中度或最佳读取所需的会话代码管理。 </li><li>如果接触质量有待提高，指导学员按照预先设定的故障排除步骤。首先，建议将压力施加到海绵的口袋。如果该DOES并不成功，让参与者施加少量的盐溶液使用洗瓶（提供任何溢出纸巾）海绵口袋里的选项。 </li><li>一旦接触良好品质实现，管理的会话一个一次性使用的解锁码。注:对于时间和幅度设定的数额这些代码进行了预编程的研究人员。 </li></ol> 7.会议结束注:在与会者进入解锁代码，该设备的屏幕上会显示倒计时的分钟，直到会议结束的计时器。该设备也将指示电极在整个会议的接触质量。当1分钟保留在计时器下，会发生在秒的倒数。 <ol><li>如果接触质量低于"温和"提供了关于如何使用6.9的故障排除步骤来改善它的说明。 </li><li>提醒参与者不要取下耳机，直到秒都充分递减计数到零，并且装置关闭（以哔噪声确认）。 </li><li>指导参与者取下耳机时，该设备会发出蜂鸣声。 </li><li>直接参与者从设备中取出海绵袋和丢弃。注射器是一次性使用，以及也应丢弃。 </li><li>确保参与者存储设备和耳机在试剂盒中。 </li><li>提醒参与者安全地存储在笔记本电脑，设备，并为下一届会议的所有材料。 </li></ol> 8.结束研究分析的<ol><li>评估使用一个参与者跟踪每个研究参与者。这可作为记录学习达标，不良事件，并会完成的方法。在研究结束时，检查每个参与者的数据，以确定研究的成功。对于这个协议的目的，研究成功将80％的参与者被定义已经完成了80％，学习班24。 </li><li>验证SES锡永成功通过日常会议签到每日疼痛评分的，审查的记录和之前和之后的刺激问卷不良事件请参阅补充代码文件抽样问卷。 注:验证的刺激的20分钟是完全可以交付试验结束时进行审查。该研究的技术人员可以访问该设备用于完成代码的确认。 </li></ol>

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A., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Impact+of+two+or+less+missing+treatment+sessions+on+tDCS+clinical+efficacy:+results+from+a+factorial,+randomized,+controlled+trial+in+major+depression.">Impact of two or less missing treatment sessions on tDCS clinical efficacy: results from a factorial, randomized, controlled trial in major depression.</a> Neuromodulation : journal of the International Neuromodulation Society. 17, 737-742 (2014).</li><li>Kurtzke, J. F. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Rating+neurologic+impairment+in+multiple+sclerosis:+an+expanded+disability+status+scale+(EDSS).">Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS).</a> Neurology. 33, 1444-1452 (1983).</li></ol>

CUNY has patents with Marom Bikson as inventor. Marom Bikson has equity in Soterix Medical Inc. CUNY has patents with Abhishek Datta as inventor. Abhishek Datta has equity in Soterix Medical Inc.

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TDC​​S。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。

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

<table><tbody><tr><td>Mini-CT transcranial direct current stimulation device</td><td>Soterix</td><td></td><td>Device to deliver direct current stimultion in a remote manner</td></tr><tr><td>Study Kit&amp;nbsp;</td><td></td><td></td><td>Provided to participant with all required setup items - device, headset, sponge pockets, pre-filled syringes, Kleenex, handheld mirro, spare batteries&amp;nbsp;</td></tr><tr><td>Laptop&amp;nbsp;</td><td></td><td></td><td>Provided to allow secure video conferecing during device setup and headset placement</td></tr><tr><td>Instruction Manual&amp;nbsp;</td><td></td><td></td><td>Transcription of instructional video and detailed instructions for protocol&amp;nbsp;</td></tr></tbody></table>

a protocol for the use of remotely-supervised transcranial direct current stimulation (tdcs) in 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.

我们已经适应了这个协议中的MS使用。我们有针对性的十TDCS刺激会交付提供了两个多星期，十9,10的前两个会议是面对面的培训课程，并在以下八个被远程监督（图3），第二届由一个环境适宜的评估那里的研究技术人员参观了参与者的家，确认相应的设定。 要完成以下远程监督会议，与会者提供了TDCS设备专门设计的用于远程使用和修改的易用性，引导正确电极放置了一个耳机。的装置试剂盒提供并包括在设备和耳机，一次性使用海绵的口袋的电极和注射器填充有生理盐水的需要为每个海绵所测量的量，与由天和器官单独标记的所有项目美化版的易用性。电极10 9,10放置成与阳极电极放置在左侧的双边背外侧前额叶皮质（DLPC）位置。这提供易于可靠电极放置，宽治疗应用。根据我们的目标1.5 mA的20分钟之前的研究会话。该协议9,10允许电流降低至1.0 mA的基线，如果这改善了整体的主题耐受性。 参加者给予配置为研究对象，包括方便的教学视频和链接，随着研究的技术人员安全的视频会议连接的一项研究提供的笔记本电脑。这款笔记本电脑还包括一个用于远程监控所有计算机活动和程序来远程访问计算机的技术支持。对于操作的详细说明书，使用由参与者和研究的技术人员都和粘合剂为自-R<html>提供了EPORT措施。 共有n个= 20 MS参与者完成了这项研究。纳入标准指定一个扩展残疾状态量表* 25 6.0或以下或6.5以上或具有代理（EDSS），以确保最小的马达要求进行操作的设备。注册已经代表，在MS的范围减值（运动障碍，认知障碍，或两者）的。所有的20名学员中，n = 4的代理，成功地训练自我应用TDCS会话和192会话总数已经完成。 如图4，40 the192会话包括培训;其余152人专门进行远程监督会议。在远程监督会议，100％是有成功放置电极，设备操作和刺激耐受性良好的传递正确执行。 负载/ 53542 / 53542fig1.jpg"/&gt; 图1.停止标准流程 。下图详细介绍了各种标准，表明参与者无法再进行或参与远程监督TDCS的研究。 <a href="https://www.jove.com/files/ftp_upload/53542/53542fig1large.jpg" target="_blank">请点击此处查看该图的放大版本。</a> <img alt="图2" src="/files/ftp_upload/53542/53542fig2.jpg" /> 图2.设备工具包。这种观点说明与独立包装海绵口袋里的设备工具包，每人每天海绵1生理盐水充式注射器，手持镜设备支架，备用生理盐水，设备与头盔。 <a href="https://www.jove.com/files/ftp_upload/53542/53542fig2large.jpg" target="_blank">请点击这里查看一个更大的版本这个数字。</a> <imgALT ="图3"SRC ="/文件/ ftp_upload / 53542 / 53542fig3.jpg"/&gt; 图3.参与者学习时间表 。这个时间表展示了一种方法，通过研究各10天参加招生周期研究试剂盒和设备。 <a href="https://www.jove.com/files/ftp_upload/53542/53542fig3large.jpg" target="_blank">请点击此处查看该图的放大版本。</a> <img alt="图4" src="/files/ftp_upload/53542/53542fig4.jpg" /> 图跨越N = 20名学员4.自申请TDCS会议。这个数字说明了完成的，自申请会跨越N = 20名学员参加了学习。初始会话完成的诊所，而其余九个交易日都通过远程监控，在参与者的家中完成。 <a href="https://www.jove.com/files/ftp_upload/53542/53542fig4large.jpg" target="_blank">请点击此处查看大v</a>版为这一数字的。

Watch this Scientific Journal Video about A Protocol for the Use of Remotely-Supervised Transcranial Direct Current Stimulation tDCS in Multiple Sclerosis MS at JoVE.com

A Protocol for the Use of Remotely-Supervised Transcranial Direct Current Stimulation tDCS in Multiple Sclerosis MS

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).

一个协议，用于远程监督经颅直流电刺激（TDCS）在多发性硬化症的使用（MS）

Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation technique that uses low amplitude direct currents to alter cortical ...

a-protocol-for-use-remotely-supervised-transcranial-direct-current

Research

JoVE Journal

Medicine

A Protocol for the Use of Remotely-Supervised Transcranial Direct Current Stimulation (tDCS) in Multiple Sclerosis (MS)

17.2K 次观看.  NYU Langone Medical Center. 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). 

视频: A Protocol for the Use of Remotely-Supervised Transcranial Direct Current Stimulation tDCS in Multiple Sclerosis MS

Simultaneous EEG Monitoring During Transcranial Direct Current Stimulation

Transcranial direct current stimulation (tDCS) is a technique that delivers weak electric currents through the scalp. This constant electric current induces shifts in neuronal membrane excitability, resulting in secondary changes in cortical activity. Although tDCS has most of its neuromodulatory effects on the underlying cortex, tDCS effects can also be observed in distant neural networks. Therefore, concomitant EEG monitoring of the effects of tDCS can provide valuable information on the mechanisms of tDCS. In addition, EEG findings can be an important surrogate marker for the effects of tDCS and thus can be used to optimize its parameters. This combined EEG-tDCS system can also be used for preventive treatment of neurological conditions characterized by abnormal peaks of cortical excitability, such as seizures. Such a system would be the basis of a non-invasive closed-loop device. In this article, we present a novel device that is capable of utilizing tDCS and EEG simultaneously. For that, we describe in a step-by-step fashion the main procedures of the application of this device using schematic figures, tables and video demonstrations. Additionally, we provide a literature review on clinical uses of tDCS and its cortical effects measured by EEG techniques.

Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that has shown initial therapeutic effects in several neurological conditions. The main mechanism underlying these therapeutic effects is the modulation of cortical excitability. Therefore, online monitoring of cortical excitability would help guide stimulation parameters and optimize its therapeutic effects. In the present article we review the use of a novel device that combines simultaneous tDCS and EEG monitoring in real time.

同时脑电图监测在经颅直流电刺激

Transcranial  direct current stimulation (tDCS) is a technique that delivers weak electric  currents through the scalp. This constant electric current ...

科研

行为学

Transcranial Direct Current Stimulation and Simultaneous  Functional Magnetic Resonance Imaging

Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation technique that uses weak electrical currents administered to the scalp to manipulate cortical excitability and, consequently, behavior and brain function. In the last decade, numerous studies have addressed short-term and long-term effects of tDCS on different measures of behavioral performance during motor and cognitive tasks, both in healthy individuals and in a number of different patient populations. So far, however, little is known about the neural underpinnings of tDCS-action in humans with regard to large-scale brain networks. This issue can be addressed by combining tDCS with functional brain imaging techniques like functional magnetic resonance imaging (fMRI) or electroencephalography (EEG).
In particular, fMRI is the most widely used brain imaging technique to investigate the neural mechanisms underlying cognition and motor functions. Application of tDCS during fMRI allows analysis of the neural mechanisms underlying behavioral tDCS effects with high spatial resolution across the entire brain. Recent studies using this technique identified stimulation induced changes in task-related functional brain activity at the stimulation site&#160;and also in more distant brain regions, which were associated with behavioral improvement. In addition, tDCS administered during resting-state fMRI allowed identification of widespread changes in whole brain functional connectivity.
Future studies using this combined protocol should yield new insights into the mechanisms of tDCS action in health and disease and new options for more targeted application of tDCS in research and clinical settings. The present manuscript describes this novel technique in a step-by-step fashion, with a focus on technical aspects of tDCS administered during fMRI.

Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation technique. It has successfully been used in basic research and clinical settings to modulate brain function in humans. This article describes the implementation of tDCS and simultaneous functional magnetic resonance imaging (fMRI), to investigate the neural basis of tDCS effects.

经颅直流电刺激和同步功能磁共振成像

Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation technique that uses weak electrical currents administered to the scalp ...

Effects of Transcranial Alternating Current Stimulation on the Primary Motor Cortex by Online Combined Approach with Transcranial Magnetic Stimulation

Transcranial Alternating Current Stimulation (tACS) is a neuromodulatory technique able to act through sinusoidal electrical waveforms in a specific frequency and in turn modulate ongoing cortical oscillatory activity. This neurotool allows the establishment of a causal link between endogenous oscillatory activity and behavior. Most of the tACS studies have shown online effects of tACS. However, little is known about the underlying action mechanisms of this technique because of the AC-induced artifacts on Electroencephalography (EEG) signals. Here we show a unique approach to investigate online physiological frequency-specific effects of tACS of the primary motor cortex (M1) by using single pulse Transcranial Magnetic Stimulation (TMS) to probe cortical excitability changes. In our setup, the TMS coil is placed over the tACS electrode while Motor Evoked Potentials (MEPs) are collected to test the effects of the ongoing M1-tACS. So far, this approach has mainly been used to study the visual and motor systems. However, the current tACS-TMS setup can pave the way for future investigations of cognitive functions. Therefore, we provide a step-by-step manual and video guidelines for the procedure.

Transcranial Alternating Current Stimulation (tACS) allows the modulation of cortical excitability in a frequency-specific fashion. Here we show a unique approach which combines online tACS with single pulse Transcranial Magnetic Stimulation (TMS) in order to "probe" cortical excitability by means of Motor Evoked Potentials.

经颅磁刺激在线联合方法对经颅交流电刺激对原发性运动皮层的影响

Transcranial Alternating Current Stimulation (tACS) is a neuromodulatory technique able to act through sinusoidal electrical waveforms in a specific ...

神经科学

Remotely Supervised Transcranial Direct Current Stimulation: An Update on Safety and Tolerability

The remotely supervised tDCS (RS-tDCS) protocol enables participation from home through guided and monitored self-administration of tDCS treatment while maintaining clinical standards. The current consensus regarding the efficacy of tDCS is that multiple treatment sessions are needed to observe targeted behavioral reductions in symptom burden. However, the requirement for patients to travel to clinic daily for stimulation sessions presents a major obstacle for potential participants, due to work or family obligations or limited ability to travel. This study presents a protocol that directly overcomes these obstacles by eliminating the need to travel to clinic for daily sessions.
This is an updated protocol for remotely supervised self-administration of tDCS for daily treatment sessions paired with a program of computer-based cognitive training for use in clinical trials. Participants only need to attend clinic twice, for a baseline and study-end visit. At baseline, participants are trained and provided with a study stimulation device, and a small laptop computer. Participants then complete the remainder of their stimulation sessions at home while they are monitored via videoconferencing software.
Participants complete computerized cognitive remediation during stimulation sessions, which may serve a therapeutic role or as a &#34;placeholder&#34; for other computer-based activity. Computers are enabled for real-time monitoring and remote control by study staff.
Outcome measures that assess feasibility and tolerance are administered remotely with the aid of visual analogue scales that are presented onscreen. Following completion of all RS-tDCS sessions, participants return to clinic for a study end visit in which all study equipment is returned.
Results support the safety, feasibility, and scalability of the RS-tDCS protocol for use in clinical trials. Across 46 patients, 748 RS-tDCS sessions have been completed. This protocol serves as a model for use in future clinical trials involving tDCS.

This manuscript provides an updated remote supervision protocol that enables participation in transcranial direct current stimulation (tDCS) clinical trials while receiving treatment sessions from home. The protocol has been successfully piloted in both patients with multiple sclerosis and Parkinson&#39;s disease.

远程监督的经颅直流电刺激: 安全性和耐受的最新进展

The remotely supervised tDCS (RS-tDCS) protocol enables participation from home through guided and monitored self-administration of tDCS treatment while ...

Combined Transcranial Magnetic Stimulation and Electroencephalography of the Dorsolateral Prefrontal Cortex

Transcranial magnetic stimulation (TMS) is a non-invasive method that produces neural excitation in the cortex by means of brief, time-varying magnetic field pulses. The initiation of cortical activation or its modulation depends on the background activation of the neurons of the cortical region activated, the characteristics of the coil, its position and its orientation with respect to the head. TMS combined with simultaneous electrocephalography (EEG) and neuronavigation (nTMS-EEG) allows for the assessment of cortico-cortical excitability and connectivity in almost all cortical areas in a reproducible manner. This advance makes nTMS-EEG a powerful tool that can accurately assess brain dynamics and neurophysiology in test-retest paradigms that are required for clinical trials. Limitations of this method include artifacts that cover the initial brain reactivity to stimulation. Thus, the process of removing artifacts may also extract valuable information. Moreover, the optimal parameters for dorsolateral prefrontal (DLPFC) stimulation are not fully known and current protocols utilize variations from the motor cortex (M1) stimulation paradigms. However, evolving nTMS-EEG designs hope to address these issues. The protocol presented here introduces some standard practices for assessing neurophysiological functioning from stimulation to the DLPFC that can be applied in patients with treatment resistant psychiatric disorders that receive treatment such as transcranial direct current stimulation (tDCS), repetitive transcranial magnetic stimulation (rTMS), magnetic seizure therapy (MST) or electroconvulsive therapy (ECT).

The protocol presented here is for TMS-EEG studies utilizing intracortical excitability test-retest design paradigms. The intent of the protocol is to produce reliable and reproducible cortical excitability measures for assessing neurophysiological functioning related to therapeutic interventions in the treatment of neuropsychiatric diseases such as major depression.

侧前额叶皮质联合经颅磁刺激与脑电图的研究

Transcranial magnetic stimulation (TMS) is a non-invasive method that produces neural excitation in the cortex by means of brief, time-varying magnetic ...

The Combined Use of Transcranial Direct Current Stimulation and Robotic Therapy for the Upper Limb

Neurologic disorders such as stroke and cerebral palsy are leading causes of long-term disability and can lead to severe incapacity and restriction of daily activities due to lower and upper limb impairments. Intensive physical and occupational therapy are still considered main treatments, but new adjunct therapies to standard rehabilitation that may optimize functional outcomes are being studied.
Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation technique that polarizes underlying brain regions through the application of weak direct currents through electrodes on the scalp, modulating cortical excitability. Increased interest in this technique can be attributed to its low cost, ease of use, and effects on human neural plasticity. Recent research has been performed to determine the clinical potential of tDCS in diverse conditions such as depression, Parkinson&#39;s disease, and motor rehabilitation after stroke. tDCS helps enhance brain plasticity and seems to be a promising technique in rehabilitation programs.
A number of robotic devices have been developed to assist in the rehabilitation of upper limb function after stroke. The rehabilitation of motor deficits is often a long process requiring multidisciplinary approaches for a patient to achieve maximum independence. These devices do not intend to replace manual rehabilitation therapy; instead, they were designed as an additional tool to rehabilitation programs, allowing immediate perception of results and tracking of improvements, thus helping patients to stay motivated.
Both tDSC and robot-assisted therapy are promising add-ons to stroke rehabilitation and target the modulation of brain plasticity, with several reports describing their use to be associated with conventional therapy and the improvement of therapeutic outcomes. However, more recently, some small clinical trials have been developed that describe the associated use of tDCS and robot-assisted therapy in stroke rehabilitation. In this article, we describe the combined methods used in our institute for improving motor performance after stroke.

The combined use of transcranial direct current stimulation and robotic therapy as an add-on for conventional rehabilitation therapy may result in improved therapeutic outcomes due to modulation of brain plasticity. In this article, we describe the combined methods used in our institute for improving motor performance after stroke.

经颅直流电刺激与上肢机器人治疗的联合应用

Neurologic disorders such as stroke and cerebral palsy are leading causes of long-term disability and can lead to severe incapacity and restriction of ...

Home-Based Transcranial Direct Current Stimulation Device Development: An Updated Protocol Used at Home in Healthy Subjects and Fibromyalgia Patients

Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation (NIBS) method, which modulates the membrane potential of neurons in the cerebral cortex by a low-intensity direct current. tDCS is a low-cost technique with minimal adverse effects and easy application. This neurostimulation method has a promising future to improve pain therapy, treatment of neuropsychiatric disorders, and physical rehabilitation.
Current studies demonstrate the benefits of using tDCS over consecutive multiple sessions. However, the daily displacement to the specialized centers, travel costs, and disruptions to daily activities are some of the difficulties faced by patients. Thus, to be more comfortable, easy-to-use, and not disrupt daily commitments, a home-based tDCS was designed. Therefore, the objective of this study was to evaluate the feasibility of a portable tDCS device for home use in healthy subjects and fibromyalgia patients.
Despite increased tDCS use and a reasonably large body of research on the effects across a range of clinical conditions, there is a limited amount of research on developing secure devices that guarantee the dose and contain a block system to avoid excessive use. Therefore, we used a tDCS device with a security system to permit daily use for 20 minutes with a minimal interval of 12 hours between sessions. A programmer preconfigures the equipment, which has a neoprene cap that allows the electrode positions in any assembly, according to individualized protocols for treatments or research. After, researchers can assess the effectiveness of treatment, and its adherence using information kept in the device software.
Results suggest that the device is feasible for home use, with proper monitoring of adherence and contact impedance. There were reports of a few adverse effects, which do not differ from those reported in the literature in studies with the treatment under direct supervision.

This study provides an updated home-based tDCS protocol that enables subjects to receive the beneficial effects of tDCS at home with an easy to use device with settings to control the use and dosage, enhancing the feasibility for long-term use at home.

基于家庭的经颅直流电刺激装置的研制: 在家庭中使用的最新协议在健康和纤维肌痛患者中的应用

Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation (NIBS) method, which modulates the membrane potential of neurons in the ...

医学

Measuring and Manipulating Functionally Specific Neural Pathways in the Human Motor System with Transcranial Magnetic Stimulation

Understanding interactions between brain areas is important for the study of goal-directed behavior. Functional neuroimaging of brain connectivity has provided important insights into fundamental processes of the brain like cognition, learning, and motor control. However, this approach cannot provide causal evidence for the involvement of brain areas of interest. Transcranial magnetic stimulation (TMS) is a powerful, noninvasive tool for studying the human brain that can overcome this limitation by transiently modifying brain activity. Here, we highlight recent advances using a paired-pulse, dual-site TMS method with two coils that causally probes cortico-cortical interactions in the human motor system during different task contexts. Additionally, we describe a dual-site TMS protocol based on cortical paired associative stimulation (cPAS) that transiently enhances synaptic efficiency in two interconnected brain areas by applying repeated pairs of cortical stimuli with two coils. These methods can provide a better understanding of the mechanisms underlying cognitive-motor function as well as a new perspective on manipulating specific neural pathways in a targeted fashion to modulate brain circuits and improve behavior. This approach may prove to be an effective tool to develop more sophisticated models of brain-behavior relations and improve diagnosis and treatment of many neurological and psychiatric disorders.

This article describes new approaches to measure and strengthen functionally specific neural pathways with transcranial magnetic stimulation. These advanced noninvasive brain stimulation methodologies can provide new opportunities for the understanding of brain-behavior relations and development of new therapies to treat brain disorders.

利用颅内磁刺激测量和操纵人体运动系统中功能特定的神经通路

Understanding interactions between brain areas is important for the study of goal-directed behavior. Functional neuroimaging of brain connectivity has ...

Updated Technique for Reliable, Easy, and Tolerated Transcranial Electrical Stimulation Including Transcranial Direct Current Stimulation

Transcranial direct current stimulation (tDCS) is a noninvasive method of neuromodulation using low-intensity direct electrical currents. This method of brain stimulation presents several potential advantages compared to other techniques, as it is noninvasive, cost-effective, broadly deployable, and well-tolerated provided proper equipment and protocols are administered. Even though tDCS is apparently simple to perform, correct administration of the tDCS session, especially the electrode positioning and preparation, is vital for ensuring reproducibility and tolerability. The electrode positioning and preparation steps are traditionally also the most time consuming and error-prone. To address these challenges, modern tDCS techniques, using fixed-position headgear and pre-assembled sponge electrodes, reduce complexity and setup time while also ensuring that the electrodes are consistently placed as intended. These modern tDCS methods present advantages for research, clinic, and remote-supervised (at home) settings. This article provides a comprehensive step-by-step guide for administering a tDCS session using fixed-position headgear and pre-assembled sponge electrodes. This guide demonstrates tDCS using commonly applied montages intended for motor cortex and dorsolateral prefrontal cortex (DLPFC) stimulation. As described, selection of the head size and montage-specific headgear automates electrode positioning. Fully assembled pre-saturated snap-electrodes are simply affixed to the set position snap-connectors on the headgear. The modern tDCS method is shown to reduce setup time and reduce errors for both novice and expert operators. The methods outlined in this article can be adapted to different applications of tDCS as well as other forms of transcranial electrical stimulation (tES) such as transcranial alternating current stimulation (tACS) and transcranial random noise stimulation (tRNS). However, since tES is application specific, as appropriate, any methods recipe is customized to accommodate subject, indication, environment, and outcome specific features.

When administering transcranial direct current stimulation (tDCS), reproducible electrode preparation and placement are vital for a tolerated and effective session. The purpose of this article is to demonstrate updated modern setup procedures for the administration of tDCS and related transcranial electrical stimulation techniques, such as transcranial alternating current stimulation (tACS).

用于可靠、简单和耐受的颅内电刺激（包括颅内直流刺激）的更新技术

Transcranial direct current stimulation (tDCS) is a noninvasive method of neuromodulation using low-intensity direct electrical currents. This method of ...

通过远程经颅直流电刺激治疗幻肢痛

Using Home-based, Remotely Supervised, Transcranial Direct Current Stimulation for Phantom Limb Pain

Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation technique that uses low-amplitude direct currents to alter cortical excitability. Previous trials have established the safety and tolerability of tDCS, and its potential to mitigate symptoms. However, the effects are cumulative, making it more difficult to have adherence to the treatment since frequent visits to the clinic or outpatient center are required. Moreover, the time needed for transportation to the center and the related expenses limit the accessibility of the treatment for many participants.
Following guidelines for remotely supervised transcranial direct current stimulation (RS-tDCS) implementation, we propose a protocol designed for remotely supervised and home-based participation that uses specific devices and materials modified for patient use, with real-time monitoring by researchers through an encrypted video conferencing platform. We have developed detailed instructional materials and structured training procedures to allow for self- or proxy-administration while supervised remotely in real time. This protocol has a specific design to have a series of checkpoints during training and execution of the visit. This protocol is currently in use in a large pragmatic study of RS-tDCS for phantom limb pain (PLP). In this article, we will discuss the operational challenges of conducting a home-based RS-tDCS session and show methods to enhance its efficacy with supervised sessions.

作者聚焦:对幻肢痛的远程监督神经调控程序的见解

The goal of this study is to describe a protocol for the home-based delivery of remotely supervised transcranial direct current stimulation (RS-tDCS) conserving the standard procedures of in-clinic practice, including safety, reproducibility, and tolerability. The participants included will be patients with phantom limb pain (PLP).

使用基于家庭的、远程监督的经颅直流电刺激治疗幻肢痛

Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation technique that uses low-amplitude direct currents to alter cortical ...