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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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 border="0" cellpadding="0" cellspacing="0" width="793">
	<tbody>
		<tr height="42">
			<td height="42" style="height:42px;width:184px;">Mini-CT transcranial direct current stimulation device</td>
			<td style="width:71px;">Soterix</td>
			<td style="width:119px;"></td>
			<td style="width:419px;">Device to deliver direct current stimultion in a remote manner</td>
		</tr>
		<tr height="21">
			<td height="21" style="height:21px;width:184px;">Study Kit&#160;</td>
			<td style="width:71px;">NA</td>
			<td style="width:119px;"></td>
			<td>Provided to participant with all required setup items - device, headset, sponge pockets, pre-filled syringes, Kleenex, handheld mirro, spare batteries&#160;</td>
		</tr>
		<tr height="21">
			<td height="21" style="height:21px;width:184px;">Laptop&#160;</td>
			<td style="width:71px;">NA</td>
			<td style="width:119px;"></td>
			<td>Provided to allow secure video conferecing during device setup and headset placement</td>
		</tr>
		<tr height="21">
			<td height="21" style="height:21px;width:184px;">Instruction Manual&#160;</td>
			<td style="width:71px;">NA</td>
			<td style="width:119px;"></td>
			<td>Transcription of instructional video and detailed instructions for protocol&#160;</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)

17.0K 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

A Protocol for Comprehensive Assessment of Bulbar Dysfunction in Amyotrophic Lateral Sclerosis (ALS)

Improved methods for assessing bulbar impairment are necessary for expediting diagnosis of bulbar dysfunction in ALS, for predicting disease progression across speech subsystems, and for addressing the critical need for sensitive outcome measures for ongoing experimental treatment trials. To address this need, we are obtaining longitudinal profiles of bulbar impairment in 100 individuals based on a comprehensive instrumentation-based assessment that yield objective measures. Using instrumental approaches to quantify speech-related behaviors is very important in a field that has primarily relied on subjective, auditory-perceptual forms of speech assessment1. Our assessment protocol measures performance across all of the speech subsystems, which include respiratory, phonatory (laryngeal), resonatory (velopharyngeal), and articulatory. The articulatory subsystem is divided into the facial components (jaw and lip), and the tongue. Prior research has suggested that each speech subsystem responds differently to neurological diseases such as ALS. The current protocol is designed to test the performance of each speech subsystem as independently from other subsystems as possible. The speech subsystems are evaluated in the context of more global changes to speech performance. These speech system level variables include speaking rate and intelligibility of speech.
The protocol requires specialized instrumentation, and commercial and custom software. The respiratory, phonatory, and resonatory subsystems are evaluated using pressure-flow (aerodynamic) and acoustic methods. The articulatory subsystem is assessed using 3D motion tracking techniques. The objective measures that are used to quantify bulbar impairment have been well established in the speech literature and show sensitivity to changes in bulbar function with disease progression. The result of the assessment is a comprehensive, across-subsystem performance profile for each participant. The profile, when compared to the same measures obtained from healthy controls, is used for diagnostic purposes. Currently, we are testing the sensitivity and specificity of these measures for diagnosis of ALS and for predicting the rate of disease progression. In the long term, the more refined endophenotype of bulbar ALS derived from this work is expected to strengthen future efforts to identify the genetic loci of ALS and improve diagnostic and treatment specificity of the disease as a whole. The objective assessment that is demonstrated in this video may be used to assess a broad range of speech motor impairments, including those related to stroke, traumatic brain injury, multiple sclerosis, and Parkinson disease.

A Protocol for Comprehensive Assessment of Bulbar Dysfunction in Amyotrophic Lateral Sclerosis ALS

Objective assessments of the physiological mechanisms that support speech are needed to monitor disease onset and progression in persons with ALS and to quantify treatment effects in clinical trials. In this video, we present a comprehensive, instrumentation-based protocol for quantifying speech motor performance in clinical populations.

延髓功能障碍肌萎缩性脊髓侧索硬化症（ALS）的综合评估议定书

Improved methods for assessing bulbar impairment are necessary for expediting diagnosis of bulbar dysfunction in ALS, for predicting disease progression ...

科研

医学

Utilizing Transcranial Magnetic Stimulation to Study the Human Neuromuscular System

Transcranial magnetic stimulation (TMS) has been in use for more than 20 years 1, and has grown exponentially in popularity over the past decade. While the use of TMS has expanded to the study of many systems and processes during this time, the original application and perhaps one of the most common uses of TMS involves studying the physiology, plasticity and function of the human neuromuscular system. Single pulse TMS applied to the motor cortex excites pyramidal neurons transsynaptically 2 (Figure 1) and results in a measurable electromyographic response that can be used to study and evaluate the integrity and excitability of the corticospinal tract in humans 3. Additionally, recent advances in magnetic stimulation now allows for partitioning of cortical versus spinal excitability 4,5. For example, paired-pulse TMS can be used to assess intracortical facilitatory and inhibitory properties by combining a conditioning stimulus and a test stimulus at different interstimulus intervals 3,4,6-8. In this video article we will demonstrate the methodological and technical aspects of these techniques. Specifically, we will demonstrate single-pulse and paired-pulse TMS techniques as applied to the flexor carpi radialis (FCR) muscle as well as the erector spinae (ES) musculature. Our laboratory studies the FCR muscle as it is of interest to our research on the effects of wrist-hand cast immobilization on reduced muscle performance6,9, and we study the ES muscles due to these muscles clinical relevance as it relates to low back pain8. With this stated, we should note that TMS has been used to study many muscles of the hand, arm and legs, and should iterate that our demonstrations in the FCR and ES muscle groups are only selected examples of TMS being used to study the human neuromuscular system.

Transcranial magnetic stimulation (TMS) is a non-invasive tool to gain insight on the physiology and function of the human nervous system. Here, we present our TMS techniques to study cortical excitability of the upper limb and lumbar musculature.

利用经颅磁刺激，以研究人类的神经肌肉系统

Transcranial magnetic stimulation (TMS) has been in use for more than 20 years 1, and has grown exponentially in popularity over the past decade.  While ...

Clinical Testing and Spinal Cord Removal in a Mouse Model for Amyotrophic Lateral Sclerosis (ALS)

Amyotrophic lateral sclerosis (ALS) is a fatal neurodegenerative disorder resulting in progressive degeneration of motoneurons. Peak of onset is around 60 years for the sporadic disease and around 50 years for the familial disease. Due to its progressive course, 50% of the patients die within 30 months of symptom onset. In order to evaluate novel treatment options for this disease, genetic mouse models of ALS have been generated based on human familial mutations in the SOD gene, such as the SOD1 (G93A) mutation. Most important aspects that have to be evaluated in the model are overall survival, clinical course and motor function. Here, we demonstrate the clinical evaluation, show the conduction of two behavioural motor tests and provide quantitative scoring systems for all parameters. Because an in depth analysis of the ALS mouse model usually requires an immunohistochemical examination of the spinal cord, we demonstrate its preparation in detail applying the dorsal laminectomy method. Exemplary histological findings are demonstrated. The comprehensive application of the depicted examination methods in studies on the mouse model of ALS will enable the researcher to reliably test future therapeutic options which can provide a basis for later human clinical trials.

Clinical Testing and Spinal Cord Removal in a Mouse Model for Amyotrophic Lateral Sclerosis ALS

A mouse model for amyotrophic lateral sclerosis (ALS) is examined clinically and behaviorally. As a prerequisite for an accompanying immunohistological analysis the preparation of the spinal cord is depicted in detail.

临床试验和脊髓去除在肌萎缩性侧索硬化症的小鼠模型（ALS）

Amyotrophic lateral sclerosis (ALS) is a fatal neurodegenerative disorder resulting in progressive degeneration of motoneurons. Peak of onset is around 60 ...

Utilizing Repetitive Transcranial Magnetic Stimulation to Improve Language Function in Stroke Patients with Chronic Non-fluent Aphasia

Transcranial magnetic stimulation (TMS) has been shown to significantly improve language function in patients with non-fluent aphasia1. In this experiment, we demonstrate the administration of low-frequency repetitive TMS (rTMS) to an optimal stimulation site in the right hemisphere in patients with chronic non-fluent aphasia. A battery of standardized language measures is administered in order to assess baseline performance. Patients are subsequently randomized to either receive real rTMS or initial sham stimulation. Patients in the real stimulation undergo a site-finding phase, comprised of a series of six rTMS sessions administered over five days; stimulation is delivered to a different site in the right frontal lobe during each of these sessions. Each site-finding session consists of 600 pulses of 1 Hz rTMS, preceded and followed by a picture-naming task. By comparing the degree of transient change in naming ability elicited by stimulation of candidate sites, we are able to locate the area of optimal response for each individual patient. We then administer rTMS to this site during the treatment phase. During treatment, patients undergo a total of ten days of stimulation over the span of two weeks; each session is comprised of 20 min of 1 Hz rTMS delivered at 90% resting motor threshold. Stimulation is paired with an fMRI-naming task on the first and last days of treatment. After the treatment phase is complete, the language battery obtained at baseline is repeated two and six months following stimulation in order to identify rTMS-induced changes in performance. The fMRI-naming task is also repeated two and six months following treatment. Patients who are randomized to the sham arm of the study undergo sham site-finding, sham treatment, fMRI-naming studies, and repeat language testing two months after completing sham treatment. Sham patients then cross over into the real stimulation arm, completing real site-finding, real treatment, fMRI, and two- and six-month post-stimulation language testing.

We explore the use of repetitive transcranial magnetic stimulation (rTMS) to improve language abilities in patients with chronic stroke and non-fluent aphasia. After identifying a site in the right frontal gyrus for each patient that responds optimally to stimulation, we target this site during ten days of rTMS treatment.

利用重复经颅磁刺激改善脑卒中患者的语言功能与慢性非流利性失语

Transcranial magnetic stimulation (TMS) has been shown to significantly improve language function in patients with non-fluent aphasia1. In this ...

Technique and Considerations in the Use of 4x1 Ring High-definition Transcranial Direct Current Stimulation (HD-tDCS)

High-definition transcranial direct current stimulation (HD-tDCS) has recently been developed as a noninvasive brain stimulation approach that increases the accuracy of current delivery to the brain by using arrays of smaller "high-definition" electrodes, instead of the larger pad-electrodes of conventional tDCS. Targeting is achieved by energizing electrodes placed in predetermined configurations. One of these is the 4x1-ring configuration. In this approach, a center ring electrode (anode or cathode) overlying the target cortical region is surrounded by four return electrodes, which help circumscribe the area of stimulation. Delivery of 4x1-ring HD-tDCS is capable of inducing significant neurophysiological and clinical effects in both healthy subjects and patients. Furthermore, its tolerability is supported by studies using intensities as high as 2.0 milliamperes for up to twenty minutes.
Even though 4x1 HD-tDCS is simple to perform, correct electrode positioning is important in order to accurately stimulate target cortical regions and exert its neuromodulatory effects. The use of electrodes and hardware that have specifically been tested for HD-tDCS is critical for safety and tolerability. Given that most published studies on 4x1 HD-tDCS have targeted the primary motor cortex (M1), particularly for pain-related outcomes, the purpose of this article is to systematically describe its use for M1 stimulation, as well as the considerations to be taken for safe and effective stimulation. However, the methods outlined here can be adapted for other HD-tDCS configurations and cortical targets.

Technique and Considerations in the Use of 4x1 Ring High-definition Transcranial Direct Current Stimulation HD-tDCS

High-definition transcranial direct current stimulation (HD-tDCS), with its 4x1-ring montage, is a noninvasive brain stimulation technique that combines both the neuromodulatory effects of conventional tDCS with increased focality. This article provides a systematic demonstration of the use of 4x1 HD-tDCS, and the considerations needed for safe and effective stimulation.

技术和注意事项在使用4X1环高清晰度的经颅直流电刺激（HD-TDCS）

High-definition transcranial direct current stimulation (HD-tDCS) has recently been developed as a noninvasive brain stimulation approach that increases ...

The Multiple Sclerosis Performance Test (MSPT): An iPad-Based Disability Assessment Tool

Precise measurement of neurological and neuropsychological impairment and disability in multiple sclerosis is challenging. We report a new test, the Multiple Sclerosis Performance Test (MSPT), which represents a new approach to quantifying MS related disability. The MSPT takes advantage of advances in computer technology, information technology, biomechanics, and clinical measurement science. The resulting MSPT represents a computer-based platform for precise, valid measurement of MS severity. Based on, but extending the Multiple Sclerosis Functional Composite (MSFC), the MSPT provides precise, quantitative data on walking speed, balance, manual dexterity, visual function, and cognitive processing speed. The MSPT was tested by 51 MS patients and 49 healthy controls (HC). MSPT scores were highly reproducible, correlated strongly with technician-administered test scores, discriminated MS from HC and severe from mild MS, and correlated with patient reported outcomes. Measures of reliability, sensitivity, and clinical meaning for MSPT scores were favorable compared with technician-based testing. The MSPT is a potentially transformative approach for collecting MS disability outcome data for patient care and research. Because the testing is computer-based, test performance can be analyzed in traditional or novel ways and data can be directly entered into research or clinical databases. The MSPT could be widely disseminated to clinicians in practice settings who are not connected to clinical trial performance sites or who are practicing in rural settings, drastically improving access to clinical trials for clinicians and patients. The MSPT could be adapted to out of clinic settings, like the patient&#8217;s home, thereby providing more meaningful real world data. The MSPT represents a new paradigm for neuroperformance testing. This method could have the same transformative effect on clinical care and research in MS as standardized computer-adapted testing has had in the education field, with clear potential to accelerate progress in clinical care and research.

The Multiple Sclerosis Performance Test MSPT: An iPad-Based Disability Assessment Tool

Precise measurement of neurological and neuropsychological impairment and disability in multiple sclerosis is challenging. We report methodologic details on a new test, the Multiple Sclerosis Performance Test (MSPT). This new approach to the objective of quantification of MS related disability provides a computer-based platform for precise, valid measurement of MS severity.

多发性硬化症性能测试（MSPT）：一个iPad为基础的残疾评估工具

Precise measurement of neurological and neuropsychological impairment and disability in multiple sclerosis is challenging. We report a new test, the ...

A Method of Trigonometric Modelling of Seasonal Variation Demonstrated with Multiple Sclerosis Relapse Data

This report describes a novel Stata-based application of trigonometric regression modelling to 55 years of multiple sclerosis relapse data from 46 clinical centers across 20 countries located in both hemispheres. Central to the success of this method was the strategic use of plot analysis to guide and corroborate the statistical regression modelling. Initial plot analysis was necessary for establishing realistic hypotheses regarding the presence and structural form of seasonal and latitudinal influences on relapse probability and then testing the performance of the resultant models. Trigonometric regression was then necessary to quantify these relationships, adjust for important confounders and provide a measure of certainty as to how plausible these associations were. Synchronization of graphing techniques with regression modelling permitted a systematic refinement of models until best-fit convergence was achieved, enabling novel inferences to be made regarding the independent influence of both season and latitude in predicting relapse onset timing in MS. These methods have the potential for application across other complex disease and epidemiological phenomena suspected or known to vary systematically with season and/or geographic location.

Combining plot analysis with trigonometric regression is a robust method for exploring complex, cyclical phenomena such as relapse onset timing in multiple sclerosis (MS). This method enabled unbiased characterisation of seasonal trends in relapse onset permitting novel inferences around the influence of seasonal variation, ultraviolet radiation (UVR) and latitude.

季节变化的三角建模的方法证明与多发性硬化症复发数据

This report describes a novel Stata-based application of trigonometric regression modelling to  55 years of multiple sclerosis relapse data from 46 ...

Adapted Resistance Training Improves Strength in Eight Weeks in Individuals with Multiple Sclerosis

Hip weakness is a common symptom affecting walking ability in people with multiple sclerosis (MS). It is known that resistance strength training (RST) can improve strength in individuals with MS, however; it remains unclear the duration of RST that is needed to make strength gains and how to adapt hip strengthening exercises for individuals of varying strength using only resistance bands. This paper describes the methodology to set up and implement an adapted resistance strength training program, using resistance bands, for individuals with MS. Directions for pre- and post-strength tests to evaluate efficacy of the strength-training program are included. Safety features and detailed instructions outline the weekly program content and progression. Current evidence is presented showing that significant strength gains can be made within 8 weeks of starting a RST program. Evidence is also presented showing that resistance strength training can be successfully adapted for individuals with MS of varying strength with little equipment.

Hip weakness is a common symptom affecting walking ability in people with multiple sclerosis. Isolated muscle strengthening is a useful method to target specific weaknesses. This protocol describes a progressive resistance-training program using exercise bands to increase hip muscle strength.

改编阻力训练提高力量在八周内的个人与多发性硬化症

Hip weakness is a common symptom affecting walking ability in people with multiple sclerosis (MS). It is known that resistance strength training (RST) can ...

Bioluminescence and Near-infrared Imaging of Optic Neuritis and Brain Inflammation in the EAE Model of Multiple Sclerosis in Mice

Experimental autoimmune encephalomyelitis (EAE) in SJL/J mice is a model for relapsing-remitting multiple sclerosis (RRMS). Clinical EAE scores describing motor function deficits are basic readouts of the immune-mediated inflammation of the spinal cord. However, scores and body weight do not allow for an in vivo assessment of brain inflammation and optic neuritis. The latter is an early and frequent manifestation in about 2/3 of MS patients. Here, we show methods for bioluminescence and near-infrared live imaging to assess EAE evoked optic neuritis, brain inflammation, and blood-brain barrier (BBB) disruption in living mice using an in vivo imaging system. A bioluminescent substrate activated by oxidases primarily showed optic neuritis. The signal was specific and allowed the visualization of medication effects and disease time courses, which paralleled the clinical scores. Pegylated fluorescent nanoparticles that remained within the vasculature for extended periods of time were used to assess the BBB integrity. Near-infrared imaging revealed a BBB leak at the peak of the disease. The signal was the strongest around the eyes. A near-infrared substrate for matrix metalloproteinases was used to assess EAE-evoked inflammation. Auto-fluorescence interfered with the signal, requiring spectral unmixing for quantification. Overall, bioluminescence imaging was a reliable method to assess EAE-associated optic neuritis and medication effects and was superior to the near-infrared techniques in terms of signal specificity, robustness, ease of quantification, and cost.

We show a technique for in vivo live bioluminescence and near-infrared imaging of optic neuritis and encephalitis in the experimental autoimmune encephalomyelitis (EAE) model for multiple sclerosis in SJL/J mice.

多发性硬化症的小鼠模型EAE视神经炎及脑部炎症的生物发光和近红外成像

Experimental autoimmune encephalomyelitis (EAE) in SJL/J mice is a model for relapsing-remitting multiple sclerosis (RRMS). Clinical EAE scores describing ...

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 ...