Dual Channel Rehabilitation Technology Promotes Rapid Recovery of Upper Limbs After Stroke
2022年8月2日 更新者:Ran Li、Fu Xing Hospital, Capital Medical University
Effects of Transcranial Direct Current Stimulation and Motor Imagery for the Recovery of Upper Limb Function of Stroke Patients
The injury and remodeling mechanism about upper extremity motor network after stroke is not clear.
There are few studies on the motor network covering cortex, white matter and blood perfusion at the time.
Some studies have shown that metal imagery activates the cortex through active mental simulation.
Our previous study has shown that passive application of transcranial direct current stimulation causes subthreshold polarization and promotes the effective integration of residual brain high-level network.
This study proposes a hypothesis: transcranial Direct Current Stimulation + Motor Imagery combines active and passive neuromodulation techniques to produce dual channel effect, which can synergistically excite motor cortex, remodel the motor network and optimize cerebral perfusion.
The research contents include clarify the effect of transcranial Direct Current Stimulation + Motor Imagery neuromodulation therapy through comprehensive randomized controlled trial study; present the process of brain injury and secondary neural plasticity through the motor network construction, functional connectivity strength and cerebral perfusion with Blood Oxygen Level Dependent, Diffusion Tensor Imaging and Arterial Spin Labeling multimodal magnetic resonance technology; calculate the correlation between motor score and brain functional network, extract the key nodes that can promote the motor network remodeling.
The research results are expected to provide preliminary theoretical foundations for further research on the injury and remodeling mechanism about upper extremity motor network after stroke.
研究概览
地位
招聘中
研究类型
介入性
注册 (预期的)
80
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:Ran Li, Doctor
- 电话号码:+86-010-88062907
- 邮箱:liran817@sina.com
研究联系人备份
- 姓名:Yong Wang, Doctor
- 电话号码:+86-010-88062908
- 邮箱:li20140821@yeah.net
学习地点
-
-
Beijing
-
Beijing、Beijing、中国、100000
- 招聘中
- Fu Xing Hospital, Capital Medical University
-
接触:
- Ran Li, Doctor
- 电话号码:+86-010-88062907
- 邮箱:liran817@sina.com
-
-
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 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:
- First stroke with upper limb motor dysfunction
- No rapid natural recovery in the last week
- Greater than 1 month since stroke onset
- Pass the motor imagery test
Exclusion Criteria:
- Severe cognitive disorder
- Severe spasm or joint contracture
- Mental implants in vivo
- Do not sign the informed consent
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:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预:Control group
Stroke patients accept the traditional rehabilitation alone.
|
|
|
有源比较器:Transcranial Direct Current Stimulation group
Stroke patients accept the Transcranial Direct Current Stimulation alone.
|
Transcranial Direct Current Stimulation with two saline-soaked electrodes (5cm x 7cm) is applied by our occupational therapist.
The anode is placed on the ipsilesional primary motor cortex (C3/C4).
The cathode is placed on the contralesional shoulder.
The current is 1.5 milliampere and lasts 20 minutes.
|
|
有源比较器:Motor imagery group
Stroke patients do the motor imagery alone.
|
Stroke patients are asked to watch a video about the upper extremity movement.
The video lasts 20 minutes.
The contents are as follows: the patients are asked to relax the muscles for the first 2 minutes; the action refers to shoulder flexion and extension, elbow flexion and extension, forearm pronation and supination, wrist flexion and extension, finger flexion and extension, and corresponding daily functional activities for 16min; the patients are asked to relax their mind and body for the last 2 minutes.
|
|
实验性的:Transcranial Direct Current Stimulation and motor imagery group
Stroke patients accept the Transcranial Direct Current Stimulation and do the motor imagery at the same time.
|
The treatment parameters are the same as the above.
It should be emphasized that the participants sit and perform the motor imagery task while receiving Transcranial Direct Current Stimulation.
|
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 |
|---|---|---|
|
Behavioral assessment by Fugl-Meyer Assessment for Upper Limb
大体时间:Baseline
|
Complete the scale at baseline
|
Baseline
|
|
Behavioral assessment by Fugl-Meyer Assessment for Upper Limb change
大体时间:Immediately after intervention
|
Change from baseline Action Research Arm Test immediately after intervention is obtained by subtracting the baseline from the later Fugl-Meyer Assessment score.
|
Immediately after intervention
|
|
Behavioral assessment by Action Research Arm Test
大体时间:Baseline
|
Complete the above scale at baseline
|
Baseline
|
|
Behavioral assessment by Action Research Arm Test change
大体时间:Immediately after intervention
|
Change from baseline Action Research Arm Test immediately after intervention is obtained by subtracting the baseline from the later Action Research Arm Test score.
|
Immediately after intervention
|
|
Motor network construction
大体时间:Baseline
|
Construct the motor network with the bilateral primary motor cortices, supplementary motor cortices, premotor cortices, thalami and cerebellums et al. as the nodes of the network.
Motor network analysis consists the network strength, global efficiency and local efficiency.
The software used is PANDA and GRETNA.
|
Baseline
|
|
Motor network change
大体时间:Immediately after intervention
|
Change from baseline motor network immediately after intervention is obtained by subtracting the baseline from the later network strength, global efficiency and local efficiency.
|
Immediately after intervention
|
|
Cerebral perfusion calculation
大体时间:Baseline
|
The volume of interest covers the motor related territory including bilateral primary motor cortices, supplementary motor cortices, premotor cortices, thalami and cerebellums et al.
The mean Cerebral Blood Flow value is calculated.
The software used is Function Tool.
|
Baseline
|
|
Cerebral perfusion change
大体时间:Immediately after intervention
|
Change from baseline cerebral perfusion immediately after intervention is obtained by subtracting the baseline from the later Cerebral Blood Flow value.
|
Immediately after 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
- 研究主任:Lirong Huo, Doctor、Office of academic research, Fu Xing Hospital, Capital Medical University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Lee J, Lee A, Kim H, Shin M, Yun SM, Jung Y, Chang WH, Kim YH. Different Brain Connectivity between Responders and Nonresponders to Dual-Mode Noninvasive Brain Stimulation over Bilateral Primary Motor Cortices in Stroke Patients. Neural Plast. 2019 Apr 7;2019:3826495. doi: 10.1155/2019/3826495. eCollection 2019.
- Marquez JL, Conley AC, Karayanidis F, Miller J, Lagopoulos J, Parsons MW. Determining the benefits of transcranial direct current stimulation on functional upper limb movement in chronic stroke. Int J Rehabil Res. 2017 Jun;40(2):138-145. doi: 10.1097/MRR.0000000000000220.
- Kaneko F, Shibata E, Hayami T, Nagahata K, Aoyama T. The association of motor imagery and kinesthetic illusion prolongs the effect of transcranial direct current stimulation on corticospinal tract excitability. J Neuroeng Rehabil. 2016 Apr 15;13:36. doi: 10.1186/s12984-016-0143-8.
- Lioi G, Butet S, Fleury M, Bannier E, Lecuyer A, Bonan I, Barillot C. A Multi-Target Motor Imagery Training Using Bimodal EEG-fMRI Neurofeedback: A Pilot Study in Chronic Stroke Patients. Front Hum Neurosci. 2020 Feb 18;14:37. doi: 10.3389/fnhum.2020.00037. eCollection 2020.
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6月9日
初级完成 (预期的)
2023年12月1日
研究完成 (预期的)
2024年6月1日
研究注册日期
首次提交
2021年6月12日
首先提交符合 QC 标准的
2021年6月21日
首次发布 (实际的)
2021年6月29日
研究记录更新
最后更新发布 (实际的)
2022年8月4日
上次提交的符合 QC 标准的更新
2022年8月2日
最后验证
2022年8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.