Effects of Individualized Accurate Positioning TMS Based on Task fMRI Activation on Upper Extremity Function After Stroke
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Fugl-Meyer Assessment-Upper Extremity
研究概览
简要总结
Stroke is a global health problem and a leading cause of disability. Limitation of upper limb function occurs in 55 -75% of patients after stroke. In recent years, non-invasive brain stimulation techniques, such as repetitive transcranial magnetic stimulation (rTMS), have been shown that can promote functional recovery in stroke patients, and multiple studies have reported that low-frequency rTMS stimulation on the motor areas of the unaffected hemispheres of stroke patients can significantly improve motor function of the affected upper limb. The standard procedure for TMS to determine the primary motor area is to measure hotspot, which is used as a common target for movement disorders such as hemiplegia after stroke. In the 1990s, the hands-on task activation point determined by functional magnetic resonance imaging(fMRI) and positron emission computed tomography(PET) studies was located at "Hand Knob" in the primary motor area. The study found that although the hands-on task activation point was closer to hotspot, it was significantly different from hotspot. The hands-on task activation point had stronger functional connection with the whole brain, especially the motor cognition-related brain area. Therefore, this study aims to compare the efficacy of rTMS stimulation on individual rTMS targets(task fMRI activation point) with traditional hotspot in patients with post-stroke hemiplegia. The regulation effect of rTMS was evaluated by using local brain function indicators and functional connections, and the longitudinal change pattern of brain function before and after treatment was observed to explore the therapeutic targets of rTMS for motor dysfunction after stroke and the mechanism of brain functional plasticity.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with ischemic stroke;
- •Primary onset, non-lateral motor area stroke lesion, duration of disease 15 days to 1 year;
- •Hemiplegia with unilateral hemispheric injury;
- •Brunnstrom grading (Brunnstrom, 1966)≤ STAGE IV;
- •Unconscious disorder;
- •Can cooperate to complete scale assessment, MRI scan and TMS treatment;
- •Can complete manual tasks and obtain activation points in the lateral motor area of the healthy hemisphere;
- •The head movement amplitude of all fMRI images was translational < 2mm and rotational < 2°;
- •Consent to rTMS treatment on the basis of conventional treatment and pass TMS safety screening;
排除标准
- •Use of muscle relaxation drugs recently;
- •A history of epilepsy;
- •History of other neuropsychiatric diseases;
- •Other motor system diseases;
- •History of head trauma and serious heart disease;
- •Contraindications to MRI scanning (implantable pacemaker, cardiac catheter or electronic pump; Intracerebral metal aneurysm clip, metal nail or vascular suture device; Intracerebral nerve stimulator or brain/subdural electrode, etc.)
- •Skull defect was closed with metal plate at TMS stimulation site;
- •Patients with skull defect;
- •Other severe systemic diseases or clinical critical conditions (respiratory or hemodynamic instability);
- •Refuse to participate in the trial.
研究组 & 干预措施
Hotspot-rTMS Group
rTMS stimulate on the hotspot of unaffected hemisphere
干预措施: Transcranial magnetic stimulation (Device)
fMRI-rTMS Group
rTMS stimulate on the motor task activation poin (targeted by fMRI) of unaffected hemisphere
干预措施: Transcranial magnetic stimulation (Device)
结局指标
主要结局
Fugl-Meyer Assessment-Upper Extremity
时间窗: At the end of 4 weeks of rTMS
Only scoring for the upper limb motor function, including 33 items, scores range from 0 to 66 points. The higher scores, the better upper limb function.
Fugl-Meyer Assessment-Upper Extremity Scale
时间窗: 2 months after the end of rTMS
Only scoring for the upper limb motor function, including 33 items, scores range from 0 to 66 points. The higher scores, the better upper limb function.
次要结局
- Regional homogeneity (ReHo), Amplitude of low-frequency fluctuation (ALFF), Functional connectivity (FC)(At the end of 4 weeks of rTMS; 2 months after the end of rTMS)
- National Institute of Health Stroke Scale(At the end of 4 weeks of rTMS; 2 months after the end of rTMS)
- Latency of motor evoked potential, Amplitude of motor evoked potential(At the end of 4 weeks of rTMS; 2 months after the end of rTMS)
- Surface electromyogram measurement(At the end of 4 weeks of rTMS; 2 months after the end of rTMS)
- Action Research Arm Test(At the end of 4 weeks of rTMS; 2 months after the end of rTMS)
- Barthel Index(At the end of 4 weeks of rTMS; 2 months after the end of rTMS)