Effects of Transcranial Direct Current Stimulation and Motor Imagery for the Recovery of Upper Limb Function of Stroke Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Behavioral assessment by Action Research Arm Test
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
Because of the different therapies, it is not possible to mask the participant. It was possible to mask the group allocation for routine rehabilitation therapist. However, the difference is obvious between Transcranial Direct Current Stimulation and motor imagery. Outcome measure is conducted by a physician who is blinded to group assignment.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Severe cognitive disorder
- •Severe spasm or joint contracture
- •Mental implants in vivo
- •Do not sign the informed consent
结局指标
主要结局
Behavioral assessment by Action Research Arm Test
时间窗: Baseline
Complete the above scale at baseline
Behavioral assessment by Fugl-Meyer Assessment for Upper Limb
时间窗: Baseline
Complete the scale at baseline
Motor network change
时间窗: 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.
Cerebral perfusion calculation
时间窗: 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.
Behavioral assessment by Fugl-Meyer Assessment for Upper Limb change
时间窗: 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.
Behavioral assessment by Action Research Arm Test change
时间窗: 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.
Cerebral perfusion change
时间窗: Immediately after intervention
Change from baseline cerebral perfusion immediately after intervention is obtained by subtracting the baseline from the later Cerebral Blood Flow value.
Motor network construction
时间窗: 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.
次要结局
未报告次要终点
研究者
Ran Li
Doctor Li
Fu Xing Hospital, Capital Medical University