作者希望感谢纽约城市学院的合作者和 Soterix 医生对他们的帮助和支持。

在石溪大学和纽约大学朗格尼医疗中心的机构审查委员会已经批准了所有的程序和设备协议. 
 1. 参与者的招募和筛选 <ol> <li> 通过从 IRB 批准的学习医师的推荐中招募潜在的参与者. </li>
	<li> 联系参与者并执行筛选以确认基本资格, 然后再进行基线研究访问 (参见补充文件 1). 
	<ol> <li> 通过远程管理认知功能测试来评估认知能力, ( 例如, 符号数字模式测试或 SDMT) 14 。在他们的年龄组别中, 由于担心他们的认知能力, 而不符合三标准的健康规范的平均值. </li>
		<li> 通过电话简要评估潜在参与者和 #39 的病史。评估纳入和排除标准。排除标准可以是基于最近的协商一致安全文件 1 。评估纳入标准的以下部分, 包括患者必须为18岁或以上, 并有以下情况: 了解和有能力给予同意, 适当的家庭设施, 以存储设备和执行 RS tDCS 会议, 清除所有的学习程序由一个学习医生, 并在国内稳定的互联网接入. 
		注: 为基线访问分配足够的时间, 以便研究医师可以清除潜在参与者。在本研究协议的当前迭代中, 通常需要至少3小时来完成所有基线过程、调查表和神经心理测试. </li>
		<li> 对每位患者和 #39 的疾病相关的残疾率 ( 例如, , 扩大残疾状态量表 (EDSS) 15 仅对 MS 患者进行评分)。患有严重残疾的参与者 ( 例如 EDSS 评分以上和 #160; 6.5) 将在医疗服务代理的帮助下完成每日 tDCS 会话。医疗保健代理将代表参与者完成需要更高级移动的设备和 headstrap 准备步骤. </li>
		<li> 在假对照研究中, 根据被阻挡的分层表的规定, 随机化参与者为活动或假状态。该表 stratifies 参与者基于筛选 16 期间收集的认知功能和伤残评分。任何使用假的研究都应该双, 并有一个 un-blinded 的学习技术员, 他们不会监督参与者和 #39 的日常会话, 分配条件, 为参与者和学习人员准备学习设备. </li>
	</ol> </li> </ol> 2。基线研究访问 <ol> <li> 管理神经心理学评估和自我报告调查表. 
	<ol> <li> 选择相关的神经心理学评估 (如多发性硬化症 (BICAMS) 17 的简要国际认知评估, 基于各自的患者群体。管理措施和评估参与者的运动和认知能力. </li>
		<li> 管理与特定于患者和 #39 的症状相关的自我分析调查表; 疾病。例如, 统一的帕金森病和 #39 疾病评定量表 (UPDRS) 18 是一种广泛使用的临床自我评估问卷, 用于测量帕金森和 #39 的具体症状。同样, 多发性硬化神经心理学调查表 (MSNQ) 的设计和验证, 以衡量在日常生活中特别在多发性硬化患者的心理能力 19 , 20 . 管理通用症状评定清单 (如患者报告的结果测量信息系统 (信息系统) 21 和正、负影响计划 (PANAS) 22 ) 以允许患者群体之间的比较. </li>
	</ol> </li> </ol> <img alt="Figure 1" class="xfigimg" src="/files/ftp_upload/56211/56211fig1.jpg"/> 图 1 : 在两项研究中使用的左阳极 DLPFC 蒙太奇. #160; 红色和蓝色补丁分别是左阳极和右阴极的模拟表示, 放置在头皮上。<a href="//ecsource-jove-com.bdigitaluss.remotexs.co/files/ftp_upload/56211/56211fig1large.jpg"> 请单击此处查看此图的较大版本. </a> 
<ol start="2"> <li> 指示和培训参与者自我 tDCS. 
	<ol> <li> 向参与者显示指导性的 tDCS 培训视频, 其中详细介绍了管理刺激的整个 step-by 步骤过程. </li>
		<li> 请参与者在学习人员的指导下准备 headstrap。headstrap 保持海绵电极的位置在整个刺激会议期间。
		<ol> <li> 参与者将海绵 (pre-moistened 5 毫升盐水溶液) 连接到电缆电极上. </li>
			<li> 指示参与者将 headstrap 放在他们的头上, 注意将 nasion 标记放在 headstrap 的前部和鼻梁上. </li>
			<li> 让参与者将 headstrap 向后拉向其头部的后端, 这样 headstrap 的背部就会停留在他们的 inion 上。侧前额叶皮层 (DLPFC), 左阳极 tDCS 蒙太奇是使用 23 , 24 , 25 , 26 , 27 . </li> <li> 确认参与者在继续之前已达到最佳或适度的联系质量. 
			注意: 该设备根据阳极和阴极电极之间的整个电阻路径 (包括皮肤和头骨阻抗) 动态调整其电压, 以提供一致的安培量。如果接触质量较差或阻抗太高, 设备无法解锁以释放刺激. </li>
			<li> 如果参与者的接触质量较差或中等, 则建议采用提高接触质量的方法, 如在海绵中添加生理盐水、调整 headstrap 位置或从电极部位刷掉头发。参与者可以通过查看设备和 #39 的界面屏幕来监视其自身的接触质量. </li>
			<li> 评估参与者和 #39 的能力, 以完成学习程序, 以确定他们是否理解并能够在家里熟练地复制程序. </li>
		</ol> </li> <li> 参与者完成耐受性测试持续90秒, 以确定他们是否能够舒适地告诉2.0 毫安直流电。如果参加者发现他们不能处理 2.0 ma, 减少安培量到 1.5 ma 和进一步到 1.0 ma, 如果认为必要。如果参加者发现 1.0 mA 不能容忍, 他们必须停止从研究. </li>
	</ol> </li> <li> 在诊所中进行第一个 tDCS 会话. 
	<ol> <li> 在准备 headstrap 和开始刺激会话之前, 请参与者报告前一天晚上的睡眠时间, 以及由于刺激、疾病特定的疼痛、疲劳和情绪而经历的任何痛苦。在开庭前借助视觉模拟天平. </li>
		<li> 确认触点质量仍为最佳或适中。提供设备解锁代码以开始参与者和 #39 的刺激会话. </li>
		<li> 开始刺激, 并提供一个可容忍的刺激量 (如上所述) 的预期二十分钟。刺激和 #39 的长度取决于研究所确定的参数;对于本文所提出的所有研究, 刺激长度为二十分钟。如果参与者被随机到假的情况, 参与者在会议开始时和会议结束时只收到一分钟的刺激, 其间的安培量会上升到目标可承受的刺激期前三十秒, 然后坡道回到0毫安在最后三十秒, 为了说服参与者, 他们正在接受刺激。除了第一和最后一分钟, 假参与者没有得到18分钟的刺激. </li>
		<li> 参与者在学习技术员的指导下完成认知补救。根据研究的预期目标, 可将认知补救方法换成不同的补救策略。同样, 可以修改补救策略的长度. 
		注: 通过按压和 #34, 可随时停止刺激; 零和 #34; 在设备上, 立即开始中止刺激通过向下向下向下0毫安。研究技术员指示参加者中止会议和结束刺激时, 任何疼痛报告在7以上的1-10 视觉模拟量表或如果任何其他紧急情况发生. </li>
		<li> 十分钟后, 询问参与者是否正在经历刺激的痛苦。研究技术人员通过视频会议软件监视放置位置, 以确定电极放置在刺激会话期间不会移位, 并且仍然可以接受. </li>
		<li> 在额外的十分钟后, 预编程的 tDCS 设备会关闭并停止刺激。该设备发出一个响亮的蜂鸣音, 通知参与者刺激已经结束。如果参与者有假的条件, 那么在二十分钟的会话的最后一分钟, 设备再次上升, 提供三十秒的目标刺激电流, 然后在最后的三十秒内向下坡道到0毫安。会话. </li>
		<li> 再次要求参与者报告他们因设备、特定疾病而引起的疼痛、疲劳和情绪, 以及在会议过程中可能遇到的任何不良事件. </li>
		<li> 为剩余的学习会话定期计划时间, 以确保标准化目的的日常一致性。此外, 为 pd 患者, 协调会议时间, 使刺激发生在1-3 小时内, 他们最后剂量的 pd 药物-一个时间窗口, 研究批准的医生确定将提供最大的利益, 根据前帕金森和 #39 的患者在认知和运动方面有了更大的改善 (如在参加者和 #39 期间提供了统一的帕金森和 #39、疾病评定量表或 UPDRS); #34; #34; 药物状态 vs。#34; #34; 药物状态 11 . </li>
	</ol> </li> </ol> 3。家庭 tDCS 会话 <ol> <li> 参与者在学习会话之前完成计算机准备工作. 
	<ol> <li> 参与者在任何进一步的学习过程之前都可以在家里连接到 internet。没有稳定的互联网在他们的家中的参与者被排除在所有的学习程序. </li>
		<li> 使用远程桌面软件连接到参与者和 #39 的计算机 28 , 并参与与参与者的 HIPAA 兼容的视频会议 29 。
		<li> 研究技术员管理研究结果的措施, 其中参与者报告前一天晚上的睡眠量和因设备而引起的疼痛、疾病的具体疼痛、疲劳以及在刺激期前的情绪, 并借助视觉模拟天平。请参与者报告在前一天和 #39 的会议之后可能发生的任何不良事件 (参见补充文件2和 3). </li>
	</ol> </li> <li> 参与者远程激活刺激。
	<ol> <li> 参与者通过将 pre-moistened 海绵连接到正面 headstrap 内侧的电极来准备 headstrap。海绵电极容易捕捉到 headstrap, 以尽量减少准备工作. </li>
		<li> 参与者将 headstrap 放在他们的头上, 作为学习技术员监控位置。参与者报告的接触质量, 这是由设备测试和评估海绵放置和海绵饱和度测量的 tDCS 装置。如前所述, 中等和不良的接触质量是补救的建议, 从研究人员, 如添加额外的盐水溶液或检查海绵放置. </li>
		<li> 口头说明将设备解锁给参与者的刺激代码, 并允许对刺激进行二十分钟的管理. </li>
		<li> 如果参与者的 EDSS 分数高于 6.5, 则医疗保健代理将完成上述步骤以代替参与者. </li>
	</ol> </li> <li> 参与者在二十分钟的刺激期内完成计算机化的认知补救。补救包括专门针对工作记忆系统的认知训练任务。我们的一个以前的出版物详述了关于我们的第一个试验性研究的认知结果 8 . 
	<ol> <li> 在10分钟的刺激之后, 请参与者报告他们可能遇到的任何痛苦. </li>
	</ol> </li> <li> 参与者完成后处理过程。
	<ol> <li> 参与者脱下 headstrap 并处理研究海绵. </li>
		<li> 要求参与者在会议结束后报告任何因设备、疾病而引起的疼痛、疲劳和情绪, 以及他们在会议期间可能遇到的任何不良事件。记录随其强度和持续时间发生的任何不良事件. </li>
		<li> 计划第二天的会话. </li>
	</ol> </li> </ol> 4。刺激后访问 <ol> <li> 管理神经心理学评估和自我报告调查表. 
	<ol> <li> 在最终的刺激会议结束后, 尽快安排最终的研究访问. </li>
		<li> 管理在基线访问期间完成的研究结果措施第二次评估患者是否因刺激而受益 17 . </li>
		<li> 获取和消毒所有学习设备. </li>
	</ol> </li> <li> 为被分配了假条件的参与者提供了完成额外的十活动、开放、RS-tDCS 会话的选项。这个开放标签研究期间是仿照我们的第一个 tDCS 试点研究苏p 类 = "xref" > 6 . </li>
</ol> 5。一个月随访调查 <ol> <li> 在研究结束一个月后向参与者伸出手, 询问他们是否会远程完成一项在线调查, 询问他们是否认为从刺激中获得的好处仍然存在. </li> </ol>

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作者没有什么可透露的。

这项研究使用了 DLPFC 左阳极蒙太奇24, 但这可以很容易地互换的另一个蒙太奇和刺激的影响可能会相应改变。根据刺激的位置, 所经历的脑部效应和副作用可能会改变1。刺激类型, 如意欲抑制而不是刺激, 也会影响效果。同样, 与刺激配对的补救形式也可能影响研究的结果31。未来的实验需要进行不同的补救策略配对与 RS-tDCS, 以确定其具体影响。
虽然 RS-tDCS 协议的重点是提供 tDCS 的病人在他们的家园, 可能仍然有一个地方的刺激提供的临床设置。例如, 更复杂的蒙太奇 (如 HD tDCS 使用的那些) 在家里即使经过适当的培训32也可能不可行。RS-tDCS 协议提供了一个详细的程序, 以确保临床试验标准的治疗疗程和剂量控制, 同时提供刺激在家使用远程康复协议。均匀电极的制备和放置以及简化的程序, 包括采用简单的海绵电极技术, 确保参与者之间的一致性。RS-tDCS 协议允许由认知和身体受损的个人完成刺激疗程, 否则, 他们每天都会有很大的困难到达诊所。
所有的故障诊断都可以立即由与参加者在 at-home 刺激会议期间的现场视频会议的研究人员解决。在研究笔记本电脑出现故障的情况下, 简单地重新启动计算机可以解决技术问题。如果研究设备故障从膝上型电脑或 tDCS 设备不解决在技术支持以后, 则研究人员应该安排交付新, 适当地运作的设备。
该协议本质上依赖于 internet 访问, 这是该方法的最大限制。目前, 没有互联网的人不能参加任何使用 RS-tDCS 的试验。与我们的协议一起使用的互联网使我们的 RS-tDCS 协议中的远程监控得以实现。
RS-tDCS 仍然是 at-home 交付 tDCS33的少数公认和可行的协议之一。与该议定书一起完成的大量会议 (748 在一年中很少), 说明了该议定书的有效性, 因为其他中心报告了较小和缺乏动力的研究。RS-tDCS 协议已有效地提供 tDCS 直接给患者的广泛的残疾。通过使用 RS-tDCS 协议进行临床试验, 可以快速征聘和迅速完成试验。
RS-tDCS 协议是可其他神经系统的条件。正如这里所演示的, 我们已经将我们的协议推广到 PD, 并计划在其他情况下证明该协议的适用性。刺激参数和修复策略都可以根据具体的治疗结果进行调整。

经颅直流电刺激 (tDCS) 是一种无创脑刺激, 具有广泛的潜在的治疗用途。轻度电流 (通常≤2.5 mA) 是通过电极放置在头皮上, 通过改变神经元极化1来影响大脑活动。tDCS 在提高训练结果的努力中通常与康复策略配对。其他流行形式的调节, 如重复经颅磁刺激, 是用于类似的目的, 但缺乏 tDCS 的关键优势, 如其可移植性, 简单的适用性, 并相对便宜1,2.
累计临床福利需要多个 tDCS 会话1,3。行为的影响, 如减少疲劳或抑郁症状, 依赖于重复的, 连续的会话。例如, 在二十或更多的会话45之后, 研究只观察到这种治疗效果。
通常情况下, tDCS 是由训练有素的临床医生或研究人员, 熟悉设备的侧面和操作和刺激方法。这是昂贵的病人和临床医生作为重要的时间, 诊所的空间, 和旅行是必需的。为了解决日常、门诊 tDCS 的需要, 我们开发了远程监控 tDCS (RS-tDCS)6。该协议使 at-home tDCS 会议能够通过研究人员通过笔记本电脑提供的受控监督和指导来完成, 并且只需要参与者进行两次门诊访问 (基线和研究结束访问)。
选择这一方案的病人群体包括多发性硬化症 (MS) 和帕金森病 (PD) 的患者。这两种疾病都给病人造成了明显的缺陷, 例如患者的疲劳症状和 PD 患者的运动障碍. tDCS 提供了一个独特的机会, 以改善疲劳症状7和认知功能紊乱8, 9、10以及促进马达学习和控制11,12。本研究纳入了代表疾病严重程度的参与者, 并采取了 tDCS 所允许的步骤, 以适应其各自的残疾。
在这些人群中, 与 MS 或 PD 的人可能有明显的障碍, 以防止他们方便地到达诊所。运动障碍, 如禁闭轮椅或认知缺陷, 导致失去自主权, 可以限制其纳入临床试验或其他认知研究。此外, 家庭和专业义务减少了参加诊所的时间, 限制了仅限于诊所13的认知补救试验的可用性。这些病人的群体, 由于其不同的损害范围, 作为模型群体, 以测试的限制和可行性的 RS-tDCS。
RS-tDCS 协议标志着 tDCS 领域的一个重要步骤, 因为它研究了刺激的使用, 因为它将被管理在病人的护理在家里。该协议加强了招聘率, 试验完成率, 减轻病人负担, 并尽量减少临床成本。在此, 我们报告了该协议的具体细节, 以及在远程管理设备的可行性、安全性和耐受性方面的初步研究结果。

<table><tbody><tr><td>tDCS Mini-CT device</td><td>Soterix</td><td></td><td>Provides direct current stimulation</td></tr><tr><td>EASYstrap with conducting cables</td><td>Soterix</td><td></td><td>Sponges attach to the strap and the strap lays on the head</td></tr><tr><td>EASYpad sponges</td><td>Soterix</td><td></td><td>Premoistened sponges with 5mL of saline. Snaps into electodes.</td></tr><tr><td>Stream laptop</td><td>Hewlett Packard</td><td></td><td>Used for videoconferencing and cognitive remediation.</td></tr><tr><td>Device Charger</td><td>Soterix</td><td></td><td>Recharges the Mini-CT.</td></tr><tr><td>TeamViewer Software</td><td>Teamviewer</td><td></td><td>Remote desktop software that enable remote control of participant&#039;s computers.</td></tr><tr><td>Vsee Software</td><td>VSee Lab, Inc.</td><td></td><td>Enables HIPAA compliant video-conferencing</td></tr><tr><td>Lumosity</td><td>Lumos Labs</td><td></td><td>Online platform used for cognitive remediation</td></tr></tbody></table>

remotely supervised transcranial direct current stimulation: an update on safety and tolerability

远程监督的 tDCS (RS-tDCS) 协议通过引导和监测自我治理的 tDCS 治疗, 同时保持临床标准, 通过家庭参与。目前关于 tDCS 疗效的共识是, 需要多次治疗, 以观察有针对性的行为减少的症状负担。然而, 由于工作或家庭义务或有限的旅行能力, 病人每天前往诊所参加刺激疗程的要求对潜在的参与者来说是一个主要障碍。这项研究提出了一个协议, 直接克服这些障碍, 消除了需要前往诊所的日常会议。
这是一个更新的协议为远程监督自我治理的 tDCS 的日常治疗课程配对与一个程序的计算机认知训练, 用于临床试验。参加者只需两次就诊, 进行基线和学习结束访问。在基线时, 参与者接受了学习刺激设备和一台小型笔记本电脑的培训和提供。然后, 参与者在家里通过视频会议软件监控他们的刺激课程, 然后完成其余的活动。
参与者在刺激疗程中完成计算机化的认知补救, 这可能起到治疗作用, 或者作为其他计算机活动的 "占位符"。通过学习人员, 计算机能够进行 real-time 监控和远程控制。
评估可行性和耐受性的结果度量方法是借助屏幕上显示的可视化模拟比例远程管理的。在所有 RS-tDCS 会议结束后, 参加者返回诊所进行研究, 并返回所有学习设备。
结果支持 RS-tDCS 协议的安全性、可行性和可扩展性, 用于临床试验。在46患者中, 748 tDCS 疗程已经完成。本议定书是一个模型, 用于今后涉及 tDCS 的临床试验。

一项试验性研究已在石溪大学使用 RS-tDCS 协议完成, 另一项目前正在 NYULMC。各机构审查委员会批准了两个地点的所有研究程序。
由于所提出的研究都是为了试行 RS-tDCS 方法, 因此没有根据症状选择参与者, 而是对 MS 和 PD 患者采用广泛的资格标准。同样, 不能耐受刺激目标安培数的患者也可选择较低的安培量 (详见下文)。
研究 1: ms 参加者是通过劳里中心的儿科 ms 在石溪之间的日期2015年3月和2016年2月。这项试验是一项开放的 RS-tDCS 研究, 以试验该议定书在 MS 中的可行性。所有参加者明知地收到20分钟 x 1.5 ma (或 1.0 ma, 如果 1.5 ma 最初不被容忍) 开放 tDCS 应用于 DLPFC (左阳极)23,24,25,26,27.在刺激过程中, 认知训练游戏30针对注意力、信息速度和工作记忆完成。第一届会议在诊所基线访问结束时完成, 其余各届会议在两周内每天五天 (at-home) 完成, 总共九次在国内举行。这项研究总共征聘了26名参加者。
研究 2: ms 手臂-参与者与 ms 被招募通过 NYULMC 的 ms 综合护理中心之间的日期2016年1月和2016年10月。这项研究的手臂是一个随机的, 双, 假对照试验使用2.0 毫安 (或1.5 毫安, 如果 2.0 ma 不最初耐受) RS-tDCS 应用于 DLPFC (左阳极) 每天二十分钟。第一次刺激会议是在诊所基线访问结束时完成的, 其余十九 at-home 会议则在以下四周内完成 (M-f)。这项研究正在进行中, 我们报告 20 MS 参加者的调查结果, 这些参与者已经被招募并完成了这项研究。
pd 手臂-参与 pd 是通过 NYULMC 的壁画研究所的帕金森氏症和运动障碍之间的日期2016年6月和2016年12月。该 arm 的重点是在 PD 患者中试行 RS-tDCS 协议, 类似于与 MS 进行的试验研究。这项研究是开放的, 所有参加者明知地收到2.0 或1.5 毫安的 tDCS 应用于 DLPFC (左阳极)。与研究1一样, 第一届会议在基线诊所访问结束时完成, 其余的九届会在参加者的家中远程完成 (M-f)。这项研究正在进行中, 我们报告已完成的调查结果从 6 PD 参与者已被招募。
为了评估 RS-tDCS 议定书的可行性和耐受性, 我们测量了已完成的会议的百分比、不良事件率以及最常见的不良事件的平均强度。
在大约一年的时间里, 总共成功地完成了46名参加者的 748 tDCS 会议。这支持 RS-tDCS 协议的可行性。在研究 1, 2 名参与者停止了 tDCS: 一个参与者因个人义务而停止, 另一名参加者由于研究停止标准的皮肤燃烧不舒服的感觉超过7评分 (尽管没有物理烧伤)。在研究 2, 2 参与者被中止了: 一个被停止了由于异常的不良事件 "舌头刺痛", 并且其他被停止了由于痛苦等级 7 (在1-10 模拟比例) 从头疼。从 PD 队列中, 没有病人已经停止。在这项研究中, 总共有4患者被终止, 由于无法完成 RS tDCS 疗程, 因此没有一项停止。
对每种刺激类型的不良事件数进行统计, 并计算其发生率。刺激类型已被放置到四不同的类别: 1.5 ma 开放, 2.0 毫安盲, 2.0 ma 开放, 和假的条件。划分这些类别的理由是, 参与者可能对他们的感觉有不同的解释, 这取决于他们在刺激过程中的预期。如图 1所示, 三最常见的不良事件是皮肤刺痛、瘙痒和灼烧的感觉 (没有参与者受到身体灼伤)。
<img alt="Figure 2" class="xfigimg" src="/files/ftp_upload/56211/56211fig2.jpg"> 
图 2: tDCS 的不良事件发生率.1.5 ma OL 是指参加者明知地收到1.5 开放 tDCS 的会议。2.0 ma 是指参加者对所接受的刺激是盲目的, 这是 2.0 ma tDCS。2.0 ma OL 是指参加者明知地收到2.0 开放 tDCS 的会议。假指的是参加者对他们所接受的刺激是盲目的, 但仅在20分钟的开始和结束时才接受六十年代的刺激, 以模拟活跃的 tDCS。<a href="//ecsource-jove-com.bdigitaluss.remotexs.co/files/ftp_upload/56211/56211fig2large.jpg" target="_blank">请单击此处查看此图的较大版本.</a>
计算了最常见的不良事件的平均强度。如表 1所示, 在任何刺激条件下, 最常见的不良事件的平均强度不超过 3 (1-10 视觉模拟量表, 1 是轻度和10极端) 的分数。
<table>
	<tbody>
		<tr>
			<td>会话条件</td>
			<td>会话总数</td>
			<td>刺痛 (SD, n)</td>
			<td>瘙痒 (SD, n)</td>
			<td>燃烧 (SD, n)</td>
		</tr>
		<tr>
			<td>2.0 毫安盲</td>
			<td>201</td>
			<td>1.6 (0.8, 75)</td>
			<td>2.2 (0.9, 36)</td>
			<td>2.5 (1.3, 59)</td>
		</tr>
		<tr>
			<td>2.0 mA 打开标签</td>
			<td>104</td>
			<td>1.9 (1.2, 43)</td>
			<td>1.8 (1.1, 8)</td>
			<td>2.0 (1.4, 32)</td>
		</tr>
		<tr>
			<td>1.5 mA 打开标签</td>
			<td>268</td>
			<td>2.4 (2.2, 161)</td>
			<td>2.0 (1.6, 65)</td>
			<td>2.9 (2.0, 79)</td>
		</tr>
		<tr>
			<td>深水</td></tr></tbody></table>><td>175</td>
			<td>1.9 (1.2, 72)</td>
			<td>1.7 (0.9, 17)</td>
			<td>1.6 (1.2, 46)</td>
		
	

表 1: 在视觉模拟量表上通常有经验的不良事件的平均强度 (1-10, 轻度紧张)。
该刺激还显示了症状管理的希望, 如图 3所示。科恩的d值是为研究1和2中 MS 患者的情绪、疲劳和从基线到研究结束的疼痛而计算的。PD 患者不包括在这个分析由于小队列完成到目前为止 (n=6)。由于每项研究中的样本量较小, 所以采用效果大小分析来识别暗示功效的信号。在研究1和2的积极会议显示了更大的平均效果大小的改善。平均而言, 接受积极 tDCS 的参与者报告的积极影响更大, 而与假 tDCS 组相比, 研究结束后的负面影响、疲劳和疼痛也较少。
<img alt="Figure 3" class="xfigimg" src="/files/ftp_upload/56211/56211fig3.jpg"> 
图 3: 科恩的d用于有症状的结果度量.参加者在接受 rtDCS 20 活动会议时表现出积极的效果, 而假组的参与者则影响微乎其微。<a href="//ecsource-jove-com.bdigitaluss.remotexs.co/files/ftp_upload/56211/56211fig3large.jpg" target="_blank">请单击此处查看此图的较大版本.</a>

Watch this Scientific Journal Video about Remotely Supervised Transcranial Direct Current Stimulation: An Update on Safety and Tolerability at JoVE.com

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

这份手稿提供了一个更新的远程监督协议, 使参与经颅直流刺激 (tDCS) 临床试验, 同时接受治疗会议从家里。该协议已成功地在两个多发性硬化和帕金森病患者试点。

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 ...

remotely-supervised-transcranial-direct-current-stimulation-an-update

Universidad San Sebastian

Research

JoVE Journal

Neuroscience

8.0K 次观看.  Langone Medical Center. 这份手稿提供了一个更新的远程监督协议, 使参与经颅直流刺激 (tDCS) 临床试验, 同时接受治疗会议从家里。该协议已成功地在两个多发性硬化和帕金森病患者试点。

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

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 ...

Electrode Positioning and Montage in Transcranial Direct Current Stimulation

Transcranial direct current stimulation (tDCS) is a technique that has been intensively investigated in the past decade as this method offers a non-invasive and safe alternative to change cortical excitability2. The effects of one session of tDCS can last for several minutes, and its effects depend on polarity of stimulation, such as that cathodal stimulation induces a decrease in cortical excitability, and anodal stimulation induces an increase in cortical excitability that may last beyond the duration of stimulation6. These effects have been explored in cognitive neuroscience and also clinically in a variety of neuropsychiatric disorders &#x2013; especially when applied over several consecutive sessions4. One area that has been attracting attention of neuroscientists and clinicians is the use of tDCS for modulation of pain-related neural networks3,5. Modulation of two main cortical areas in pain research has been explored: primary motor cortex and dorsolateral prefrontal cortex7. Due to the critical role of electrode montage, in this article, we show different alternatives for electrode placement for tDCS clinical trials on pain; discussing advantages and disadvantages of each method of stimulation.

Transcranial direct current stimulation (tDCS) is an established technique to modulate cortical excitability1,2. It has been used as an investigative tool in neuroscience due to its effects on cortical plasticity, easy operation, and safe profile. One area that tDCS has been showing encouraging results is pain alleviation 3-5.

经颅直接电流刺激电极定位和蒙太奇

Transcranial direct current stimulation (tDCS) is a technique that has been intensively investigated in the past decade as this method offers a ...

神经科学

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 ...

医学

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.

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 ...

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 ...

Transcranial Direct Current Stimulation (tDCS) in Mice

Transcranial direct current stimulation (tDCS) is a non-invasive neuromodulation technique proposed as an alternative or complementary treatment for several neuropsychiatric diseases. The biological effects of tDCS are not fully understood, which is in part explained due to the difficulty in obtaining human brain tissue. This protocol describes a tDCS mouse model that uses a chronically implanted electrode allowing the study of the long-lasting biological effects of tDCS. In this experimental model, tDCS changes the cortical gene expression and offers a prominent contribution to the understanding of the rationale for its therapeutic use.

Transcranial Direct Current Stimulation tDCS in Mice

Transcranial direct current stimulation (tDCS) is a therapeutic technique proposed to treat psychiatric diseases. An animal model is essential for understanding the specific biological alterations evoked by tDCS. This protocol describes a tDCS mouse model that uses a chronically implanted electrode.

经颅直流电刺激 (tDCS) 在小鼠中的作用

Transcranial direct current stimulation (tDCS) is a non-invasive neuromodulation technique proposed as an alternative or complementary treatment for ...

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 ...

Stimulation Location Determination using a 3D Digitizer with High-Definition Transcranial Direct Current Stimulation

The abundance of neuroimaging data and rapid development of machine learning has made it possible to investigate brain activation patterns. However, causal evidence of brain area activation leading to a behavior is often left missing. Transcranial direct current stimulation (tDCS), which can temporarily alter brain cortical excitability and activity, is a noninvasive neurophysiological tool used to study causal relationships in the human brain. High-definition transcranial direct current stimulation (HD-tDCS) is a noninvasive brain stimulation (NIBS) technique that produces a more focal current compared to conventional tDCS. Traditionally, the stimulation location has been roughly determined through the 10-20 EEG system, because determining precise stimulation points can be difficult. This protocol uses a 3D digitizer with HD-tDCS to increase accuracy in determination of stimulation points. The method is demonstrated using a 3D digitizer for more accurate localization of stimulation points in the right temporo-parietal junction (rTPJ).

Presented here is a protocol to achieve higher accuracy in determination of stimulation location combining a 3D digitizer with high-definition transcranial direct current stimulation.

使用具有高清晰度颅内直接电流刺激的 3D 数字化仪确定刺激位置

The abundance of neuroimaging data and rapid development of machine learning has made it possible to investigate brain activation patterns. However, ...

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 ...