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临床试验/NCT03486769
NCT03486769已完成不适用

Effect of Dual Site-dual Channel Non-invasive Brain Stimulation for Recovery of Motor Function in Stroke Patients

Samsung Medical Center1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年5月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Changes in motor evoked potentia

研究概览

简要总结

The aim of this study is to investigate the effect of dual site-dual channel non-invasive brain stimulation for recovery of motor function in post stroke patients. Simultaneous dual site-dual channel stimulation was applied by using two sets of transcranial direct current stimulation devices. All subjects will go through three conditions of transcranial direct current stimulation with for 30 minutes. Three conditions are 1) Dual stimulation 1: i) anodal stimulation on ipsilesional primary motor cortex and cathodal stimulation on contralesional primary motor cortex, ii) anodal stimulation on ipsilesional premotor cortex and cathodal stimulation on contralesional supraorbital area. 2) Dual stimulation 2: i) anodal stimulation on ipsilesional primary motor cortex and cathodal stimulation on contralesional primary motor cortex, ii) anodal stimulation on ipsilesional anterior intraparietal sulcus and cathodal stimulation on contralesional supraorbital area. 3) Single stimulation: anodal stimulation on ipsilesional primary motor cortex and cathodal stimulation on contralesional primary motor cortex.

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 (Participant, Outcomes Assessor)

入排标准

年龄范围
19 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •unilateral hemiplegic stroke patient
  • •Fugl Meyer Assessment score between 9 to 84

排除标准

  • •difficult to understand experimental tasks because of extremely severe cognitive impairment
  • •history of psychiatric disease

研究组 & 干预措施

Dual Stimulation 1

Experimental

i) anodal stimulation on ipsilesional primary motor cortex and cathodal stimulation on contralesional primary motor cortex, ii) anodal stimulation on ipsilesional premotor cortex and cathodal stimulation on contralesional supraorbital area.

干预措施: M1 stimulation (Device)

Dual Stimulation 1

Experimental

i) anodal stimulation on ipsilesional primary motor cortex and cathodal stimulation on contralesional primary motor cortex, ii) anodal stimulation on ipsilesional premotor cortex and cathodal stimulation on contralesional supraorbital area.

干预措施: PMC stimulation (Device)

Dual Stimulation 1

Experimental

i) anodal stimulation on ipsilesional primary motor cortex and cathodal stimulation on contralesional primary motor cortex, ii) anodal stimulation on ipsilesional premotor cortex and cathodal stimulation on contralesional supraorbital area.

干预措施: hand motor task (Behavioral)

Dual Stimulation 2

Experimental

i) anodal stimulation on ipsilesional primary motor cortex and cathodal stimulation on contralesional primary motor cortex, ii) anodal stimulation on ipsilesional anterior intraparietal sulcus and cathodal stimulation on contralesional supraorbital area.

干预措施: M1 stimulation (Device)

Dual Stimulation 2

Experimental

i) anodal stimulation on ipsilesional primary motor cortex and cathodal stimulation on contralesional primary motor cortex, ii) anodal stimulation on ipsilesional anterior intraparietal sulcus and cathodal stimulation on contralesional supraorbital area.

干预措施: aIPS stimulation (Device)

Dual Stimulation 2

Experimental

i) anodal stimulation on ipsilesional primary motor cortex and cathodal stimulation on contralesional primary motor cortex, ii) anodal stimulation on ipsilesional anterior intraparietal sulcus and cathodal stimulation on contralesional supraorbital area.

干预措施: hand motor task (Behavioral)

Single stimulation

Experimental

anodal stimulation on ipsilesional primary motor cortex and cathodal stimulation on contralesional primary motor cortex

干预措施: M1 stimulation (Device)

Single stimulation

Experimental

anodal stimulation on ipsilesional primary motor cortex and cathodal stimulation on contralesional primary motor cortex

干预措施: hand motor task (Behavioral)

结局指标

主要结局

Changes in motor evoked potentia

时间窗: Baseline and after intervention (approximately 2 weeks)

measure the motor threshold and amplitude of motor evoked potential in first dorsal interosseous muscle.

次要结局

  • changes in box and block test(Baseline and after intervention (approximately 2 weeks))
  • changes in grip and tip pinch strength test(Baseline and after intervention (approximately 2 weeks))
  • Changes in brain activation of resting-state functional MRI(Baseline and after intervention (approximately 2 weeks))
  • changes in nine hole peg test(Baseline and after intervention (approximately 2 weeks))
  • Changes of Cortical activation(Baseline and after intervention (approximately 2 weeks))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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