Effect of Cerebral and Cerebellar Repetitive Transcranial Magnetic Stimulation on Motor Function in Stroke Patients
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
- 否
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
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
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
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
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
Won Hyuk Chang
Associate Professor
Samsung Medical Center
