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临床试验/NCT04903457
NCT04903457已完成不适用

Investigation of Compensational Mechanism and Effect of Transcranial Direct Stimulation on Motor Learning Through Neural Network Analysis in Stroke Patients

Samsung Medical Center2 个研究点 分布在 2 个国家目标入组 21 人开始时间: 2021年6月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
21
试验地点
2
主要终点
Fugl-Meyer Assessment

研究概览

简要总结

This study is to investigate the effect of transcranial direct current stimulation (tDCS) simulation on motor learning to stroke patients compared to sham stimulation

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
19 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Unilateral stroke including basal ganglia lesion patients
  • Chronic patients over 6 months after onset
  • Patients with the movement of fingers

排除标准

  • 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

结局指标

主要结局

Fugl-Meyer Assessment

时间窗: Baseline, immediately after five brain stimulation sessions

The score is a stroke-specific, performance-based impairment index. The degree of impairment of upper and lower limbs is measured.

次要结局

  • Changes in cortical activity using fNIRS signals during brain stimulation(Baseline, during, immediately after five brain stimulation sessions)
  • Box & Block test(Baseline, immediately after five brain stimulation sessions)
  • Grip & Tip pinch strength test(Baseline, immediately after five brain stimulation sessions)
  • Sequential Finger tapping test(Baseline, immediately after five brain stimulation sessions)
  • 9-hole pegboard test(Baseline, immediately after five brain stimulation sessions)
  • Changes in motor evoked potential(Baseline, immediately after five brain stimulation sessions)
  • Jebsen-Taylor hand function test(Baseline, immediately after five brain stimulation sessions)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yun-Hee Kim

Principal Investigator

Samsung Medical Center

研究点 (2)

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