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临床试验/NCT04638192
NCT04638192Unknown不适用

Design of Synchronized Pairing Peripheral Nerve Stimulation and Cortical Polarization to Promote Post-stroke Neuroplasticity for Hand Function Recovery

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年12月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
Magnetic resonance imaging

研究概览

简要总结

tACS has the potential to directly induce cortical alterations in the intrinsic neural oscillation at specific frequencies, and the brain could mirror the induced frequencies of the external source of oscillations from the stimulation. Hence, tACS with matching stimulation frequency could be an effective means of enhancing brain oscillatory activity to potentially induce synaptic plasticity for restoration of damaged brain functions. However from the existing studies of applying tACS over the M1 in healthy and diseased brains, there is a wide range of applied stimulation frequencies and varied neuromodulation effects on motor behavior or cortical excitability at different frequencies. In this proposal, subject-specific stimulation frequency and latency will be identified.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Hemiparesis subsequent to first-ever unilateral stroke for more than 6 months;
  • •MCP and PIP finger joints can be extended to 180° passively;
  • •Sufficient cognition to follow the experimental instructions

排除标准

  • •Severe hand spasticity or hand deformity;
  • •History of alcohol or drug abuse or epilepsy;
  • •Bilateral brain infarcts;
  • •Severe cognitive deficits;
  • •Comprehensive aphasia;
  • •Contraindications to tACS and MRI

研究组 & 干预措施

subject-specific tACS

Experimental

Constant current (1mA) will be applied for 20min at subject-specific stimulation frequency and latency

干预措施: tACS (Device)

standard tACS

Experimental

Constant current (1mA) will be applied for 20min at 20Hz with a fixed 25ms latency

干预措施: tACS (Device)

Sham tACS

Sham Comparator

The stimulator will be shut down after 30s of stimulation. The patients will feel the initial itching sensation at the beginning in order to evaluate the placebo effect

干预措施: tACS (Device)

结局指标

主要结局

Magnetic resonance imaging

时间窗: 3-month after the 10th session training

Structural and functional MRI

次要结局

  • Action Research Arm Test (ARAT)(3-month after the 10th session training)
  • Fugl-Meyer Assessment (Upper Extremity)(3-month after the 10th session training)
  • Wolf Motor Function Test (WMFT)(3-month after the 10th session training)

研究者

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

Raymond KY Tong

Chairman and Professor

Chinese University of Hong Kong

研究点 (1)

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