Efficacy and Safety of Intermittent Theta Burst Stimulation in Acute Anterior Circulation Ischemic Stroke Patients Undergoing Mechanical Thrombectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 178
- 试验地点
- 1
- 主要终点
- Proportion of patients with Modified Rankin Scale (mRS) Score 0-2 at 90 days
研究概览
简要总结
The goal of this randomized, single-blind, parallel-controlled clinical trial is to evaluate the efficacy and safety of intermittent theta burst stimulation (iTBS) as an adjunctive therapy for acute anterior circulation ischemic stroke patients who have undergone successful mechanical thrombectomy (MT). The study population includes adults aged 18-85 with NIHSS scores 5-25 post-MT and eTICI≥2b reperfusion.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-85 years, regardless of gender.
- •Acute ischemic stroke caused by occlusion of the anterior circulation large vessels (internal carotid artery, M1 or M2 segment of the middle cerebral artery), verified by CTA or DSA.
- •Mechanical thrombectomy (MT) performed within 24 hours of symptom onset.
- •Successful Reperfusion: Post-MT eTICI score ≥ 2b.
- •NIHSS score 5-25 at 24 hours post-MT, with ≥2 points in at least one limb.
排除标准
- •Pre-stroke modified Rankin Scale (mRS) score ≥
- •PH2-type intracranial hemorrhage on brain CT post-MT.
- •Patients who underwent intracranial stent placement during MT.
- •Contraindications to iTBS: History of epilepsy or seizures, implanted cardiac pacemakers, cochlear implants, or other electronic/magnetic-sensitive devices.
- •Severe consciousness impairment, cognitive dysfunction, or psychiatric disorders preventing compliance with iTBS.
- •Expected survival <3 months due to other medical conditions or inability to complete follow-up for any reason.
- •Participation in another interventional study.
- •Any other condition deemed unsuitable for enrollment by the investigator.
研究组 & 干预措施
iTBS
Patients are treated with intermittent theta burst stimulation (iTBS).
干预措施: intermittent theta burst stimulation (Device)
sham-iTBS
Patients are treated with sham intermittent theta burst stimulation (sham-iTBS).
干预措施: sham intermittent theta burst stimulation (Device)
结局指标
主要结局
Proportion of patients with Modified Rankin Scale (mRS) Score 0-2 at 90 days
时间窗: 90 days
Modified Rankin Scale (mRS) ranged from 0 to 6, a low value represents a better outcome.
次要结局
- Differences in National Institutes of Health Stroke Scale (NIHSS) Score at 7 days(7 days)
- Distribution of Modified Rankin Scale (mRS) Scores at 90 Days(90 days)
- Distribution of Modified Rankin Scale (mRS) Scores at 30 Days(30 days)
- Proportion of Patients with Early Neurological Deterioration (END) Within 7 Days(7 days)
- All-Cause Mortality Rate at 90 Days(From randomization to 90 days)
- Incidence of Intracranial Hemorrhage (ICH) and Symptomatic ICH (sICH) During Intervention(7 days)
- Rate of iTBS-Related Adverse Events(From randomization to 90 days)
- Overall Adverse Event (AE) Rate(From randomization to 90 days)
研究者
Yi Yang
Vice President of First Hospital of Jilin University
The First Hospital of Jilin University