Head-dOwn Position for ischEmic Stroke With Middle Cerebral Artery (HOPES): a Prospective, Random, Multi-Center, Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- proportion of patients with modified Rankin Score 0 to 2
研究概览
简要总结
The study is designed to explore the efficacy and safety of head-down position in patients with acute ischemic stroke。
详细描述
Currently, the guideline recommended re-perfusion such as intravenous thrombolysis and mechanical thrombectomy as the most effective treatment for acute ischemic stroke. However, the two methods are restricted by a strict time window, which greatly limits the number of the patients receiving treatment. The abundant studies have suggested that good collateral circulation can provide compensatory blood supply to save the ischemic penumbra and reduces the infarct volume, which improves the prognosis. How to improve collateral circulation in an efficient and safe way is a clinical challenge. Our recent experiment results of the animal and clinical experiments show that head-down position can significantly increase cerebral perfusion and improve neurological function. Clinically, head-down position is simple and easy to operate, and theoretically may increases brain perfusion and improve collateral circulation. A pilot randomized clinical trial is designed to investigate the effect of head-down position combined with routine rehabilitation in patients with ischemic stroke.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥18 years
- •acute ischemic stroke within 10 - 30 days of onset
- •neurological deficit: 6≤NIHSS≤16
- •Large artery atherosclerosis stroke based on TOAST criteria
- •The responsibility vessels were the middle cerebral artery or internal carotid artery, and the degree of stenosis was more than 50%.
- •first stroke onset or past stroke without obvious neurological deficit (mRS≤1)
- •fully understand and cooperate with the doctor's instructions.
- •the availability of informed consent;
排除标准
- •Hemorrhagic stroke or mixed stroke
- •Combining with severe organ dysfunction
- •Past hemorrhagic stroke
- •A history of stroke with severe sequelae
- •Planning revascularization in 3 months
- •Ischemic stroke due to surgical intervention
- •participating in other clinical trials within 3 months
- •Pregnant or lactating women
- •any inappropriate patients assessed by the researcher
结局指标
主要结局
proportion of patients with modified Rankin Score 0 to 2
时间窗: 90 days
次要结局
- The percentage of reduction in MoCA(90 days)
- proportion of patients with modified Rankin Score 0 to 1(90 days)
- occurrence of stroke(90 days)
- Incidence of major vascular events(90 days)
- the biggest tolerance time of head-down(90 days)
- The percentage of reduction in Fugl-Meyer score(90 days)
- The percentage of reduction in MMSE(90 days)
研究者
Hui-Sheng Chen
Director of neurological department
General Hospital of Shenyang Military Region