Lesion Network Mapping Navigated Continuous Theta-burst Stimulation for Motor Recovery in Acute Ischemic Stroke:A Randomized, Double-Blind, Sham-Controlled, Phase 2 Pilot Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Improvement of motor function
研究概览
简要总结
This is a multicenter, sham-controlled, double-blind, randomized clinical trial to evaluate the efficacy and safety of lesion network mapping navigated cTBS in improving motor function in patients with acute ischemic stroke within 14 days of symptom onset.
详细描述
The target population of this study was patients with acute ischemic stroke. Lesion network mapping and navigation were used to select individual stimulation targets. Enrolled patients were randomly assigned in a 1:1 ratio to the "cTBS group" or the "Sham stimulation group" and received:
cTBS group: Based on the map, an 8-shaped coil was used to stimulate the motor function-related targets. The stimulation intensity was RMT80%, 600 pulses, 50Hz, 40s per target, and the stimulation interval was more than 2 hours. The total course of treatment lasted 7 days.
Sham stimulation group: A Sham stimulation coil was used to stimulate based on the map. The sound and duration were the same as the cTBS group, ensuring no effective stimulation. The total course of treatment lasted 7 days.
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)
盲法说明
To ensure the blind method, the sham stimulation coil will be used, which has the same parameters (including stimulation frequency, time, etc.) as the cTBS group, and has the same stimulation sound to ensure no effective stimulation, to ensure the blind state is maintained during the test. Investigators and patients who participate in the study treatment or are involved in the clinical evaluation of patients will be blinded to treatment grouping.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years old.
- •Acute ischemic stroke confirmed by CT or MRI at 14 days after onset.
- •Pre-stroke modified Rankin scale (mRS) score≤
- •4≤NIHSS score≤ 25, 1a≤1, NIHSS5a/5b/6a/6b≥2 at least.
- •Moderate or severe motor dysfunction (Fugl-Meyer motor score < 80).
- •Written informed consent from patients or their legally authorized representatives.
排除标准
- •TMS contraindications include metallic foreign bodies in the head, pacemaker, implantable drug pumps, cochlear implants, etc.
- •Epilepsy or history of epilepsy, intracranial hypertension, tumor and other serious neurological disorders;
- •Midline displacement and brain parenchymal mass effect seen in head CT and other images;
- •Head CT or MRI showed bilateral acute cerebral infarction;
- •Evidence of acute intracranial hemorrhage;
- •A history of congenital or acquired hemorrhagic disease, coagulation factor deficiency, or thrombocytopenia disease;
- •After blood pressure control, the systolic blood pressure was still ≥180 mmHg or the diastolic blood pressure was ≥110 mmHg;
- •Patients during pregnancy or lactation and within 90 days of planned pregnancy;
- •Patients with severe mental disorders or dementia who can not cooperate with informed consent and follow-up;
- •Patients with malignancy or severe systemic disease and expected survival of less than 90 days;
- •Participants in other clinical intervention studies within 30 days before randomization or who were participating in other clinical intervention studies.
- •Patients with ataxia (NIHSS 7 ≥ 1) and aphasia (NIHSS 9 ≥ 2).
研究组 & 干预措施
Continuous Theta-burst Stimulation
Based on the map, an 8-shaped coil was used to stimulate the motor function-related targets. The stimulation intensity was RMT80%, 600 pulses, 50Hz, 40s per target, and the stimulation interval was more than 2 hours. The treatment course lasted for 7 days.
干预措施: Continuous Theta-burst Stimulation (Device)
Sham stimulation
A Sham stimulation coil was used to stimulate based on the map. The sound and duration were the same as the cTBS group, ensuring no effective stimulation. The treatment course lasted for 7 days.
干预措施: Sham stimulation (Device)
结局指标
主要结局
Improvement of motor function
时间窗: 7 days
Fugl-Meyer motor function score (FMMS) change from baseline at 7 days. FMMS 0-100 (higher score indicates better)
Serious adverse events ( SAEs )
时间窗: 7 days
Serious adverse events ( SAEs )
次要结局
- Excellent functional outcome(90 days)
- Funtional outcome(90 days)
- Symptomatic intracranial hemorrhage(7 days)
- Barthel index of ADL(90 days)
- EQ-5D-5L(90 days)
- Symptomatic intracranial hemorrhage(90 days)
- Mortality(90 days)
- Early neurological improvement (ENI)(7 days)
- Improvement of motor function(90 days)
- Adverse events ( AEs )(90 days)
- Stroke recurrence(90 days)
研究者
Yongjun Wang
Professor
Beijing Tiantan Hospital