Comparative Efficacy of Different Time Interval Between rTMS and Rehabilitation Program for Motor Recovery in Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Fugl-Meyer Assessment (FMA)
研究概览
简要总结
Comparative Efficacy of Different Time Interval between rTMS and Rehabilitation Program for Motor Recovery in Stroke Patients
详细描述
Stroke is one of the main causes of death and disability in Taiwan. The M1 excitability of the affected hemisphere decreases, while that of the unaffected hemisphere increases, leading to further interhemispheric inhibition. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technology. High and low frequencies of rTMS could modulate the excitability of the cerebral cortex. Through regulating the excitability of bilateral hemispheres, rTMS could facilitate motor recovery in stroke patients. Previous study had been demonstrated that priming rehabilitation program with low frequent rTMS would lead to better motor recovery in the chronic stroke patients. However, the optimal time interval between the rTMS and the rehabilitation program had not been investigated. Thus, this study will utilize low frequent rTMS, targeting the intact hemisphere, to investigate the clinical effects and motor cortex excitability under different time intervals between the rTMS and the rehabilitation program.
This study is designed as a randomized controlled trial. We plan to recruit 45 subacute stroke patients with hemiplegia. The patients are randomly assigned to three groups. In the Group 1, the patients receive contralateral 1 Hz rTMS stimulation and subsequent rehabilitation program. In the Group 2, the patients receive contralateral 1 Hz rTMS, but the rehabilitation will be delayed at least two hours after the rTMS stimulation. The control group receive sham rTMS and subsequent rehabilitation program. The treatment schedule for all groups will be five times per week for a two-week course, which means a total of ten sessions. The primary outcome is upper limb Fugl-Meyer Assessment. The secondary outcomes included Medical Research Council (MRC) scale, Barthel Scale, Modified Rankin Scale (MRS), cortical excitability assessment (including bilateral maximum MEP amplitude, MEP latency, and bilateral resting motor threshold). Follow-up time points are before rTMS and at 1st, 4th, 12th weeks after the end of the treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>=20 years old, unilateral stroke diagnosed by CT or MRI
- •Post-stroke 1 week to 6 months
- •Medical Research Council Scale for Muscle Strength in upper limb ≤ 3
- •No history of previous stroke, seizure, dementia, parkinsonism or other neurodegenerative disease
- •stable medical condition and vital signs
排除标准
- •Previous stroke, traumatic brain injury, brain tumor
- •With central nervous system disease (spinal cord injury, Parkinson's disease)
- •Any contraindication to rTMS (seizure, alcoholism, metal implant, pacemaker, Pregnancy...)
- •Patients unable to cooperate the treatment
结局指标
主要结局
Fugl-Meyer Assessment (FMA)
时间窗: 12 weeks
Fugl-Meyer Assessment (FMA) of upper limb
次要结局
- Modified Rankin Scale(12 weeks)
- motor evoked potential latency(12 weeks)
- Barthel Index(12 weeks)
- Medical Research Council (MRC) scale(12 weeks)
- Grip strength(12 weeks)
- resting motor threshold(12 weeks)
- maximal motor evoked potential amplitude(12 weeks)