Comparative Efficacy of Different Doses of Theta Burst Stimulation for Motor Recovery in Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Fugl-Meyer Assessment
研究概览
简要总结
Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technology. This study will compare efficacy of different doses iTBS in combination with inhibitory rTMS on motor recovery and cortical excitability in subacute stroke patients.
详细描述
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. Theta burst stimulation (TBS) has achieved a similar effect to traditional rTMS mode. Intermittent TBS (iTBS) could upregulate cortical excitability of the primary motor cortex (M1) and continuous TBS (cTBS) with inhibitory effect. Through modulating the excitability of bilateral hemispheres, rTMS could facilitate motor recovery in stroke patients.
This study will compare efficacy of different doses iTBS in combination with inhibitory rTMS on motor recovery and cortical excitability in subacute 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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Unilateral ischemic or hemorrhagic stroke
- •2.Stroke within 3 months
- •3.Medical Research Council Scale for Muscle Strength in upper limb ≤ 3
- •4.No previous stroke, seizure, dementia, Parkinson's disease or other degenerative neurological diseases.
- •5.Patient could sit over 15 minutes
- •6.Age over 20
排除标准
- •1.Previous stroke, traumatic brain injury, brain tumor
- •2.With central nervous system disease (spinal cord injury, Parkinson's disease)
- •3.Any contraindication to rTMS (seizure, alcoholism, metal implant, pacemaker)
- •4.Patients unable to cooperate the treatment
- •5.Pregnancy
- •6.Depression
结局指标
主要结局
Fugl-Meyer Assessment
时间窗: 12 weeks post intervention
Fugl-Meyer Assessment motor function set, score: 0-66, higher scores indicate a better outcome.
次要结局
- Barthel Index(1 week, 4 weeks, 12 weeks and 24 weeks post intervention)
- Medical Research Council (MRC) Scale for Muscle Strength(1 week, 4 weeks, 12 weeks and 24 weeks post intervention)
- Modified Rankin Scale(1 week, 4 weeks, 12 weeks and 24 weeks post intervention)
- National Institutes of Health Stroke Scale(1 week, 4 weeks, 12 weeks and 24 weeks post intervention)
- MEP(1 week, 4 weeks, 12 weeks and 24 weeks post intervention)
- Fugl-Meyer Assessment(24 weeks post intervention)