Motor Excitability Study of High Definition Transcranial Direct Current Stimulation (HD-tDCS) in Chronic Stroke
2022年11月16日 更新者：Raymond KY Tong、Chinese University of Hong Kong
High definition tDCS will be conducted to both stroke and healthy subjects on primary motor cortex area to explore the motor excitability changes before and after stimulation.
In next stage, a randomized control trial with 20-session training will be conducted to evaluate the effectiveness of transient modulation of cortical excitability through multisite HD-tDCS with EMG driven robot hand training, a sham stimulation with EMG-driven robot hand training will be applied as control group.
研究概览
研究类型
介入性
注册 (预期的)
30
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Raymond Kai-yu Tong, PhD
- 电话号码：+852 3943 8454
- 邮箱：kytong@cuhk.edu.hk
学习地点
-
-
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Hong Kong、香港
- 招聘中
- Department of Biomedical Engineering, The Chinese University of Hong Kong
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接触：
- Raymond Tong, PhD
- 电话号码：+852 3943 8454
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Sufficient cognition to follow simple instructions, as well as understand the content and purpose of the experiment;
- Have moderate to severe motor disability at the paretic upper limb (assessed by Fugl-Meter Assessment (FMA), and Action Research Arm Test (ARAT));
- Hemiparesis resulting from a single unilateral lesion of the brain with onset at least 6 months before data collection
Exclusion Criteria:
- Severe hand spasticity, open hand wound or hand deformity;
- Visual field deficits;
- Aphasia, neglect, and apraxia;
- History of alcohol, drug abuse or epilepsy;
- Bilateral infracts;
- Uncontrolled medical problems;
- Serious cognitive deficits [Mini-Mental State Examination (MMSE) < 21];
- Major depression
- Metal implants inside body
- MRI, TMS and tDCS contraindications
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：阶乘赋值
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Anode HD-tDCS
The center anode is fixed on the ipsilesional primary motor cortex and the 4 surrounding cathode electrodes will be placed about 6 cm to the center.
|
Different stimulation protocols will be applied to the primary motor cortex of stroke patients.
After 20-minute stimulation, EMG-driven robot hand training will be conducted.
|
|
实验性的：Cathode HD-tDCS
The center cathode is fixed on the contralesional primary motor cortex and the 4 surrounding anode electrodes will be placed about 6 cm to the center.
|
Different stimulation protocols will be applied to the primary motor cortex of stroke patients.
After 20-minute stimulation, EMG-driven robot hand training will be conducted.
|
|
安慰剂比较：Sham HD-tDCS
The center anode is fixed on the ipsilesional primary motor cortex and the 4 surrounding cathode electrodes will be placed about 6 cm to the center.
|
Different stimulation protocols will be applied to the primary motor cortex of stroke patients.
After 20-minute stimulation, EMG-driven robot hand training will be conducted.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Electroencephalography (EEG) and Electromyography (EMG)
大体时间：Before intervention, During intervention, After intervention, 6-month after intervention
|
It is used to investigate the changes in corticomuscular coherence for studying connectivity between the brainwave using EEG and the affected hand muscles using EMG.
In addition, EMG will be used to detect muscle activation change and muscle co-contraction pattern alteration.
|
Before intervention, During intervention, After intervention, 6-month after intervention
|
|
Action Research Arm Test (ARAT)
大体时间：Before intervention, After intervention, 6-month after intervention
|
The ARAT is a 19-item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement) to assess upper limb functioning
|
Before intervention, After intervention, 6-month after intervention
|
|
Fugl-Meyer Assessment Upper Extremity (FMA-UE)
大体时间：Before intervention, After intervention, 6-month after intervention
|
It is used to evaluate and measure upper-limb recovery in post-stroke hemiplegic patients, and items are scored on a 3-point ordinal scale
|
Before intervention, After intervention, 6-month after intervention
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Magnetic Resonance Imaging (MRI)
大体时间：Before intervention, After intervention, 6-month after intervention
|
It is used to identify neural correlates of stimulation-induced behavioral gains for investigating tDCS-induced changes in brain activations
|
Before intervention, After intervention, 6-month after intervention
|
|
Transcranial Magnetic Stimulation (TMS)
大体时间：Before intervention
|
It is used to measure the changes in interhemispheric imbalance and corticospinal excitability
|
Before intervention
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Raymond Kai-yu Tong, PhD、Department of Biomedical Engineering, CUHK
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2016年6月20日
初级完成 (预期的)
2022年12月31日
研究完成 (预期的)
2022年12月31日
研究注册日期
首次提交
2016年9月14日
首先提交符合 QC 标准的
2016年11月7日
首次发布 (估计)
2016年11月9日
研究记录更新
最后更新发布 (实际的)
2022年11月21日
上次提交的符合 QC 标准的更新
2022年11月16日
最后验证
2022年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.