Acupuncture for Cerebral Vasospasm After Subarachnoid Hemorrhage
- Conditions
- Cerebral VasospasmSAH (Subarachnoid Hemorrhage)
- Interventions
- Device: acupunctureDevice: Mock transcutaneous electrical nerve stimulationDevice: ElectroacupunctureDevice: sham intradermal acupunctureDevice: Intradermal acupuncture
- Registration Number
- NCT02275949
- Lead Sponsor
- Kyung Hee University Hospital at Gangdong
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Study group acupuncture acupuncture, electroacupuncture and intradermal acupuncture are done at every session. Study group Electroacupuncture acupuncture, electroacupuncture and intradermal acupuncture are done at every session. Study group Intradermal acupuncture acupuncture, electroacupuncture and intradermal acupuncture are done at every session. Control group sham intradermal acupuncture Mock transcutaneous electrical nerve stimulation(mock TENS) and sham intradermal acupuncture are carried out. Control group Mock transcutaneous electrical nerve stimulation Mock transcutaneous electrical nerve stimulation(mock TENS) and sham intradermal acupuncture are carried out.
- Primary Outcome Measures
Name Time Method The occurrence of delayed ischemic neurological deficit 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.
- Secondary Outcome Measures
Name Time Method The incidence of angiographic vasospasm 14 days Angiographic vasospasm is defined as focal or generalized reduction of cerebral arterial caliber on conventional cerebral angiogram or computed tomographic angiography confirmed by a neuroradiologist and neurosurgeon.
The change of nitric oxide(NO) and endothelin-1 in plasma 14days Blood sample of 3ml is taken from brachial vein and centrifuged by 3000 rpm for 15minutes and kept in a freezer before analysis. Blood sample will be taken twice, before the start of treatment and after the end of treatment. In addition, the level of serum NO and endothelin-1 between patients and healthy controls will be compared.
The incidence of TCD vasospasm 14 days TCD vasospasm is defined as Peak systolic middle cerebral artery velocity \> 200cm/s and Lindegaard ratio \>3
The incidence of vasospasm-related infarct on CT or MRI 14 days It is defined as cerebral infarction in the region of angiographic vasospasm or TCD vasospasm is shown on CT or MRI
Mortality 14 days and 28 days Mortality at the end of treatment and 14days after the treatment(or at discharge)
modified Rankin Scale (mRS) 14 days and 28 days The participan's functional status at the end of treatment and 14days after the treatment
Trial Locations
- Locations (1)
Kyung Hee University Hospital at Gangdong
🇰🇷Seoul, Gangdong-gu, Korea, Republic of