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临床试验/NCT04570774
NCT04570774已完成不适用

Effect of Cerebral and Cerebellar Repetitive Transcranial Magnetic Stimulation on Motor Function in Stroke Patients

Samsung Medical Center2 个研究点 分布在 2 个国家目标入组 56 人开始时间: 2020年10月2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
56
试验地点
2
主要终点
Difference of upper limb motor score in Fugl-Meyer assessment

研究概览

简要总结

This study is based on the characteristics of motor learning theory and motor learning neural network to improve motor function in stroke patients. This study is to investigate whether the cerebral-cerebellar repetitive transcranial magnetic stimulation (rTMS) is effective in improving motor function compared to the conventional cerebral rTMS in stroke patients.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Hemiplegic stroke patients within 1 month after onset
  • Moderate to severe motor impairment (Fugl-Meyer assessment <85)
  • Cognitive and language functions to perform more than one step of command
  • More than 19 years old

排除标准

  • Contraindicated to rTMS
  • Progressive or unstable stroke
  • Pre-existing and active major neurological disease or major psychiatric disease
  • A history of advanced liver, kidney, cardiac or pulmonary disease, a terminal medical diagnosis consistent with survival <1 year

研究组 & 干预措施

Facilitatory cerebral and cerebellar rTMS group

Experimental

Patients underwent 10 consecutive daily sessions of high-frequency repetitive transcranial magnetic stimulation (rTMS) over the affected primary motor cortex of the hand and high-frequency rTMS over the ipsilateral cerebellar hemisphere.

干预措施: Repetitive transcranial magnetic stimulation (Procedure)

Facilitatory cerebral rTMS group

Active Comparator

Patients underwent 10 consecutive daily sessions of high-frequency repetitive transcranial magnetic stimulation (rTMS) over the affected primary motor cortex of the hand and sham high-frequency rTMS over the ipsilateral cerebellar hemisphere.

干预措施: Repetitive transcranial magnetic stimulation (Procedure)

Inhibitory cerebral and cerebellar rTMS group

Experimental

Patients underwent 10 consecutive daily sessions of continous theta bust stimulation (cTBS) over the unaffected primary motor cortex of the hand and high-frequency rTMS over the ipsilateral cerebellar hemisphere.

干预措施: Repetitive transcranial magnetic stimulation (Procedure)

Inhibitory cerebral rTMS group

Active Comparator

Patients underwent 10 consecutive daily sessions of continous theta bust stimulation (cTBS) over the unaffected primary motor cortex of the hand and sham rTMS over the ipsilateral cerebellar hemisphere.

干预措施: Repetitive transcranial magnetic stimulation (Procedure)

结局指标

主要结局

Difference of upper limb motor score in Fugl-Meyer assessment

时间窗: 2 weeks

(upper limb motor score in Fugl-Meyer assessment at post-intervention) - (upper limb motor score in Fugl-Meyer assessment at baseline) Higher scores mean a better outcome

次要结局

未报告次要终点

研究者

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

Won Hyuk Chang

Associate Professor

Samsung Medical Center

研究点 (2)

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