Efficacy and Safety of Electroacupuncture Combined With rTMS on Motor Function Recovery After Stroke: A Multi-center Randomized Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 3
- 主要终点
- Fugl-Meyer Assessment (FMA)
研究概览
简要总结
This study aims to evaluate the combined efficacy of repetitive Transcranial Magnetic Stimulation (rTMS) and Electroacupuncture (EA) in improving motor function recovery post-stroke, compared to rTMS combined with sham EA. Participants will receive either active EA or sham EA alongside standard rTMS treatment. Outcomes will be assessed using standardized clinical scales and neuroimaging techniques to explore underlying neuroplasticity mechanisms.
详细描述
Motor impairment is a major cause of disability following stroke, with central and peripheral neuromodulation strategies showing potential for functional recovery. Repetitive transcranial magnetic stimulation (rTMS) has been shown to promote neuroplasticity and enhance cortical excitability. Electroacupuncture (EA), by increasing somatosensory input, may further strengthen sensorimotor integration and cortical remodeling. However, limited clinical trials have systematically evaluated the synergistic effect of rTMS combined with EA.
This multi-center randomized controlled clinical study aims to assess the efficacy of combining rTMS and EA in improving motor function post-stroke. Outcome measures include clinical scales (FMA, ARAT, FAC), kinematic parameters, electrophysiological indices (EEG, EMG, TMS), blood biomarkers, and resting-state fMRI. The study is designed to explore central-peripheral neuroplasticity mechanisms and provide evidence for integrated rehabilitation approaches.
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with stroke confirmed by neuroimaging (CT/MRI).
- •First-ever stroke, unilateral hemispheric lesion, related to motor dysfunction.
- •Age between 40 and 75 years.
- •Duration from stroke onset between 2 weeks and 6 months.
- •Brunnstrom stage II-IV.
- •Right-handed.
- •Able to understand instructions and voluntarily provide written informed consent.
排除标准
- •History of epilepsy or familial epilepsy.
- •Motor dysfunction due to non-vascular causes (e.g., tumor, trauma).
- •Severe aphasia or cognitive impairment (MoCA < 18).
- •Severe systemic complications (e.g., severe organ dysfunction, deep vein thrombosis).
- •Presence of metallic implants or contraindications for MRI.
- •Severe anxiety (HAMA > 7) or depression (HAMD > 8).
- •Severe spasticity (modified Ashworth ≥ 2).
- •Fear or intolerance of TMS or electroacupuncture.
- •Pregnancy, breastfeeding, or concurrent participation in other clinical trials affecting outcomes.
研究组 & 干预措施
Active rTMS + Sham EA group
干预措施: Sham EA (Procedure)
Active rTMS + Sham EA group
干预措施: Active rTMS (Device)
Active rTMS + Active EA group
干预措施: Active EA (Procedure)
Active rTMS + Active EA group
干预措施: Active rTMS (Device)
结局指标
主要结局
Fugl-Meyer Assessment (FMA)
时间窗: Baseline, 2 weeks post-intervention, 1month follow-up, 3months follow-up
The Fugl-Meyer Assessment is used for rating motor function recovery after stroke. Scores range from 0 to 100, with higher scores indicating better motor performance.
次要结局
- Arm Research Action Test (ARAT)(Baseline, 2 weeks post-intervention, 1month follow-up, 3months follow-up)
- Functional Ambulation Classification (FAC)(Baseline, 2 weeks post-intervention, 1month follow-up, 3months follow-up)
- Modified Barthel Index (MBI)(Baseline, 2 weeks post-intervention, 1month follow-up, 3months follow-up)
- Stroke-Specific Quality of Life Scale (SS-QOL)(Baseline, 2 weeks post-intervention, 1month follow-up, 3months follow-up)
研究者
Jing Tao
Professor
Fujian University of Traditional Chinese Medicine