The Efficacy and Safety of Acupuncture for Cerebral Vasospasm After Subarachnoid Hemorrhage
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- The occurrence of delayed ischemic neurological deficit
研究概览
简要总结
This study will evaluate acupuncture's effect of preventing vasospasm after SAH.
A total of 80 participants will be recruited and will be randomized to a study group or a control group. Acupuncture, electroacupuncture and intradermal acupuncture will be done at every session in a study group, while mock transcutaneous electrical nerve stimulation(mock TENS) and sham intradermal acupuncture will be carried out in a control group.
详细描述
Intervention starts within 96hours after SAH, after ruptured aneurysms have been secured by endovascular coiling or surgical clipping. Intervention is applied once a day, 6 days a week for 2 weeks(total 12 sessions) in addition to standard treatment such as prophylactic HHH therapy and nimodipine. Sterile disposable, stainless steel acupuncture needles are used.
Primary outcome measurement is the occurrence of delayed ischemic neurological deficit between the study group and the control group. Moreover, the incidence of angiographic vasospasm, TCD vasospasm, and vasospasm-related infarct on CT or MRI, the change of nitric oxide(NO) and endothelin-1 in plasma, mortality and participant's functional status using mRS will be compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, 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
- 是
入选标准
- •Participants conforming to all the following conditions will be included: 1) SAH verified by CT and cerebral angiography; 2) aneurysm treated by endovascular coiling or surgical clipping; 3) age > 18 years; 4) HHS 1-4; 5) acupuncture treatment can start within 96 hours after SAH; 6) participation is voluntarily and the informed consent signed.
- •Healthy controls who matched with patients in gender and age
排除标准
- •Participants with any of the following conditions will be excluded: 1) traumatic or infectious SAH; 2) HHS 5; 3) Transcranial Doppler (TCD) cannot performed; 4) heart, liver or renal failure; 5) presence of cardiac pacemaker.
研究组 & 干预措施
Study group
acupuncture, electroacupuncture and intradermal acupuncture are done at every session.
干预措施: acupuncture (Device)
Study group
acupuncture, electroacupuncture and intradermal acupuncture are done at every session.
干预措施: Electroacupuncture (Device)
Study group
acupuncture, electroacupuncture and intradermal acupuncture are done at every session.
干预措施: Intradermal acupuncture (Device)
Control group
Mock transcutaneous electrical nerve stimulation(mock TENS) and sham intradermal acupuncture are carried out.
干预措施: Mock transcutaneous electrical nerve stimulation (Device)
Control group
Mock transcutaneous electrical nerve stimulation(mock TENS) and sham intradermal acupuncture are carried out.
干预措施: sham intradermal acupuncture (Device)
结局指标
主要结局
The occurrence of delayed ischemic neurological deficit
时间窗: 14 days
The occurrence of delayed ischemic neurological deficit between the study group and the control group will be compared. DIND is defined as an unaccountable new focal neurological deficit lasting more than 2hours. Any occurrence of DIND will be recorded by the physician and verified by the investigator every day.
次要结局
- The incidence of angiographic vasospasm(14 days)
- The change of nitric oxide(NO) and endothelin-1 in plasma(14days)
- The incidence of TCD vasospasm(14 days)
- The incidence of vasospasm-related infarct on CT or MRI(14 days)
- Mortality(14 days and 28 days)
- modified Rankin Scale (mRS)(14 days and 28 days)
研究者
Seong-Uk Park
A full professor
Kyung Hee University Hospital at Gangdong