Individualized Brain Stimulation Using Transcranial Direct Current Stimulation Simulation in Stroke Patients
2023年2月1日 更新者：Yun-Hee Kim、Samsung Medical Center
This study is to investigate the effect of transcranial direct current stimulation (tDCS) simulation-based individualized stimulation compared to conventional stimulation and sham stimulation.
研究概览
研究类型
介入性
注册 (实际的)
24
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。
学习地点
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Seoul、大韩民国、06351
- Samsung Medical Center
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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
19年 至 80年 (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:
- Unilateral stroke patients
- Chronic patients over 6 months after onset
- Patients with motor evoked potential of the first dorsal interosseous muscle
- Patients with the movement of fingers
Exclusion Criteria:
- History of psychiatric disease
- Significant other neurological diseases except for stroke
- Difficult to perform this experiment
- Patients who are deemed difficult to participate in this research by the investigator
- Patients with metal implants and medical devices
- History of epilepsy
- Pregnancy
- Skin defect at the site of electrode attachment
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：交叉作业
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Individualized stimulation group
Patients receive five sessions of individualized stimulation obtained from brain image-based transcranial direct stimulation simulation.
The simulator generates the electrode's location on the scalp.
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经颅直流电刺激是一种无创神经调节形式，它使用通过头皮上的电极输送的恒定和低直流电。
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有源比较器：Conventional stimulation group
Patients receive five sessions of conventional stimulation with electrodes over C3 and C4 based on the 10-20 system.
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经颅直流电刺激是一种无创神经调节形式，它使用通过头皮上的电极输送的恒定和低直流电。
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假比较器：Sham stimulation group
Patients receive five sessions of sham stimulation with electrodes over C3 and C4 based on the 10-20 system.
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经颅直流电刺激是一种无创神经调节形式，它使用通过头皮上的电极输送的恒定和低直流电。
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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 |
|---|---|---|
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Changes in motor evoked potential
大体时间：Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)
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Resting motor threshold (rMT), amplitude, and latency of motor evoked potential in the first dorsal interosseous muscle are measured.
These outcomes are measured by transcranial magnetic stimulation over the motor hotspot.
The rMT is defined as the minimum stimulus intensity that produced a minimal motor evoked response at rest.
The amplitude means peak to peak of the muscle response.
The latency is defined as the time point from the onset of the stimulus to the onset of MEP.
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Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Jebsen-Taylor hand function test
大体时间：Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)
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This test is a standardized and objective measure of fine and gross motor hand function using simulated activities of daily living (ADL).
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Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)
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9-hole peg test
大体时间：Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)
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The test is a standardized, quantitative assessment used to measure finger dexterity of a patient.
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Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)
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Grip & Tip pinch strength test
大体时间：Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)
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The test is to measure the maximum isometric strength of hand, forearm, and finger muscles.
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Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)
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Box & Block test
大体时间：Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)
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The test is used to measure the gross manual dexterity of a patient, or of a person using an upper limb prosthetic device.
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Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)
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Fugl-Meyer Assessment
大体时间：Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)
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The score is a stroke-specific, performance-based impairment index.
The degree of impairment of upper and lower limbs is measured.
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Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)
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Sequential motor test
大体时间：Baseline, 1 day (immediately after one brain stimulation session), 5 days (immediately before and after three brain stimulation sessions), and about 14 days (immediately before and after five brain stimulation sessions)
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Response time and accuracy are measured during finger tapping task.
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Baseline, 1 day (immediately after one brain stimulation session), 5 days (immediately before and after three brain stimulation sessions), and about 14 days (immediately before and after five brain stimulation sessions)
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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。
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)
2021年1月29日
初级完成 (实际的)
2022年12月23日
研究完成 (实际的)
2022年12月23日
研究注册日期
首次提交
2021年1月5日
首先提交符合 QC 标准的
2021年1月5日
首次发布 (实际的)
2021年1月7日
研究记录更新
最后更新发布 (实际的)
2023年2月3日
上次提交的符合 QC 标准的更新
2023年2月1日
最后验证
2023年2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.