A Single-center, Prospective, Randomized, Controlled Study of Mechanical Thrombectomy Followed by Acupuncture for Acute Ischemic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 272
- 试验地点
- 1
- 主要终点
- Ratio of Modified rankin scale (mRS) score ≤2
研究概览
简要总结
To evaluate the efficacy and safety of head acupuncture combined with endovascular therapy for cerebral infarction compared with endovascular therapy alone
详细描述
Control group: Mechanical thrombectomy followed by the guideline recommended treatment for acute ischemic stroke;
Experimental group: After mechanical thrombectomy, head acupuncture and the treatment regimen recommended by the guideline for acute ischemic stroke were administered
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
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years;
- •Patients with acute ischemic stroke who received endovascular treatment within 24 hours of onset;
- •6 < NIHSS ≤25;
- •ASPECT score ≥6 points;
- •Signed Informed consent.
排除标准
- •CT or brain MRI confirmed intracranial tumor and intracranial hemorrhage;
- •Contraindications of contrast media;
- •Dementia or mental illness，unable to cooperate with treatment and follow-up;
- •The expected survival time was less than 3 months;
- •Women who are pregnant, planning to become pregnant or breastfeeding;
- •Currently participating in other clinical trials.
研究组 & 干预措施
experimental group
Mechanical thrombectomy was followed by acupuncture and guideline-based conventional treatment
干预措施: Scalp Acupuncture (Other)
experimental group
Mechanical thrombectomy was followed by acupuncture and guideline-based conventional treatment
干预措施: The treatment recommended in the guidelines for acute ischemic stroke was administered (Other)
control group
Conventional treatment based on guidelines was administered after mechanical thrombectomy
干预措施: The treatment recommended in the guidelines for acute ischemic stroke was administered (Other)
结局指标
主要结局
Ratio of Modified rankin scale (mRS) score ≤2
时间窗: 90 days after onset
The modified rankin Scale (mRS) score ≤2 indicates that the patient has the ability to live independently.
次要结局
- Modified rankin scale (mRS) score(90 days after onset)
- Incidence of cerebral hemorrhage(7 days after randomization)
- National Institute of Health stroke scale(NIHSS) score(10 days after onset)