Effect of Individualized rTMS Based on fNIRS on the Upper Limb Spasticity After Stroke
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- modified Ashworth scale
研究概览
简要总结
Stroke is of high morbidity and mortality, and surviving patients are often unable to take care of themselves because of severe motor dysfunction. The brain has plasticity, and makes adaptive changes after stroke, resulting in the reorganization and compensation of neural networks. However, the muscle tone of some patients will significantly increase during the recovery process, which affects the rehabilitation effect. Neuromodulation techniques such as repetitive transcranial magnetic stimulation (rTMS) have been widely used to promote brain network remodeling after stroke. The investigators attempted to evaluate the motor brain network characteristics of spastic patients by fNIRS, and used the most active brain regions as rTMS stimulation regions to evaluate the improvement effect of this individualized treatment on post-stroke spasticity.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 40-79 years;
- •Patients with first-onset stroke within 1 to 3 months after onset;
- •Consciousness, sitting balance level 1 or above, can cooperate with fNIRS assessment;
- •The patient or its authorized agent signs the informed consent form.
排除标准
- •Previous seizures;
- •Suffered from mental illness such as depression, anxiety, mania, and schizophrenia before the stroke onset;
- •Patients with metal on the head, cochlear implants, intracranial infections, etc. who are not suitable for rTMS.
研究组 & 干预措施
Individualized rTMS based on fNIRS
Low-frequency rTMS will be given to the most active brain regions assessed by fNIRS.
干预措施: individual rTMS based on fNIRS (Procedure)
Traditional rTMS strategy
The control group will always be given low-frequency rTMS to contralesional M1
干预措施: Traditional rTMS strategy (Procedure)
结局指标
主要结局
modified Ashworth scale
时间窗: 1 month
The range is 0-Ⅳ level, the higher the level, the higher the spasticity.
次要结局
- Fugl-Meyer Assessment of upper limb motor function(1 month)
- Barthel index(1 month)
- average weighted clustering coefficient(1 month)
- global efficiency(1 month)
- inter-density(1 month)