Efficacy and Safety of Repetitive Transcranial Magnetic Stimulation (rTMS) for Treating Movement Disorders in Patients With Intracranial Hemorrhage (ICH): A Randomized, Blinded, Sham-controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 130
- 试验地点
- 3
- 主要终点
- Change in Fugl-Meyer Assessment (FMA)
研究概览
简要总结
This pilot study aims to assess the effectiveness and safety of rTMS in the treatment of movement disorders in patients with ICH.
详细描述
While the fatality rate of intracerebral hemorrhage (ICH) has decreased, many patients continue to experience persistent limb movement dysfunction. Motor dysfunction in ICH is commonly attributed to basal ganglia hemorrhage, as the basal ganglia play a central role in the extrapyramidal motor system. Therefore, promoting the remodeling of the extrapyramidal motor system holds great significance for effectively treating ICH patients with movement disorders.
Repetitive transcranial magnetic stimulation (rTMS) is a safe and non-invasive neuromodulation technique that can modulate neuronal activity, influence neuronal synaptic plasticity, and enhance brain function. Currently, rTMS has shown promise in improving motor function among patients with stroke and those who have undergone brain tumor surgery, which provides valuable insights for its potential application in patients with motor dysfunction following ICH surgery.
This pilot study aims to evaluate the efficacy and safety of rTMS in the treatment of ICH patients with movement disorders. The participants will be randomly assigned to either a real rTMS treatment group or a sham group. The study will assess and compare various clinical outcomes, including the FMA (Fugl-Meyer Assessment), NIHSS (National Institutes of Health Stroke Scale), and BI (Barthel Index) scores, over a period of 6 months.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants between the ages of 45 and 65 years old.
- •More than 1 month and less than 3 months after ICH
- •With severe and moderately severe motor functional impairment, indicated by a Functional Motor Assessment (FMA) score ranging from 0 to
- •Unilateral basal ganglia hemorrhage with a hematoma volume of 30-60ml, measured using the ABC2 method based on preoperative CT scans.
- •Participants should have a stable level of consciousness, with a score of 0 to 1 on the level of consciousness, level of consciousness questions, and level of consciousness instructions of the National Institutes of Health Stroke Scale (NIHSS), along with stable vital signs.
- •Underwent surgical treatment for ICH within 2 weeks after the event, utilizing either craniotomy or endoscopic hematoma evacuation, with an evacuation rate of at least 80%.
- •Signed the informed consent.
排除标准
- •With a history of epilepsy.
- •With movement disorders resulting from causes other than basal ganglia hemorrhage.
- •With severe general impairment or coexisting medical conditions.
- •With emotional issues or cognitive impairments, as indicated by a Mini-Mental State Examination (MMSE) score below
- •With any contraindications to transcranial magnetic stimulation (TMS), such as having metal implants in the brain or using a pacemaker.
研究组 & 干预措施
rTMS intervention group
Participants will undergo rTMS treatment using the Magstim Rapid 2 magnetic stimulation device. The coil was placed positioned tangentially on the scalp, targeting the hot spot (thumb movement area) in the ipsilateral cerebral hemisphere. The stimulation protocol will involve 10-Hz stimulation for 2 seconds, followed by a followed by a 10-second rest, which was repeated 50 times. Patients will receive treatment once a day, five days a week (Monday to Friday), for a total of two consecutive weeks.
干预措施: rTMS with Magstim Rapid 2 magnetic stimulation device (Device)
Sham group
Patients in the sham group underwent sham stimulation using the Magstim Rapid 2 magnetic stimulation device with the same protocol. The coil was positioned to target the same hot spot, with an angulation parallel to the gyrus to the gyrus in order to additionally minimize the rTMS effect.
干预措施: sham control with Magstim Rapid 2 magnetic stimulation device (Device)
结局指标
主要结局
Change in Fugl-Meyer Assessment (FMA)
时间窗: Month 6
Motor function was evaluated using the FMA, a scale ranging from 0 to 100 that measures movement ability. Higher scores reflect better motor function. The outcome measure assesses the change in the FMA score at 6 months compared to baseline.
次要结局
- Change in Fugl-Meyer Assessment (FMA)(Day 1, Month 1, Month 3)
- Fugl-Meyer Assessment (FMA) Response(baseline, Day 1, Month 1, Month 3, Month 6)
- Change in Fugl-Meyer Assessment, Upper Limb (FMA-UL)(Day 1, Month 1, Month 3, Month 6)
- Change in Fugl-Meyer Assessment, Lower Limb (FMA-LL)(Day 1, Month 1, Month 3, Month 6)
- Change in NIH stroke scale (NIHSS) score(Day 1, Month 1, Month 3, Month 6)
- Change in Barthel Index (BI) score(Day 1, Month 1, Month 3, Month 6)
研究者
Dr. Yong Cao
director
Beijing Tiantan Hospital