Clinical trial NCT02275949: Acupuncture for Cerebral Vasospasm After Subarachnoid Hemorrhage
Official title: The Efficacy and Safety of Acupuncture for Cerebral Vasospasm After Subarachnoid Hemorrhage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: SAH (Subarachnoid Hemorrhage)
Cerebral Vasospasm
Keywords: SAH (Subarachnoid Hemorrhage)
Cerebral Vasospasm
Acupuncture
Lead sponsor: Kyung Hee University Hospital at Gangdong
Sponsor class: OTHER
First posted: 2014-10-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: The occurrence of delayed ischemic neurological deficit
timeFrame: 14 days
Secondary outcomes:
measure: The incidence of angiographic vasospasm
timeFrame: 14 days
measure: The incidence of TCD vasospasm
timeFrame: 14 days
measure: The incidence of vasospasm-related infarct on CT or MRI
timeFrame: 14 days
measure: The change of nitric oxide(NO) and endothelin-1 in plasma
timeFrame: 14days
measure: Mortality
timeFrame: 14 days and 28 days
measure: modified Rankin Scale (mRS)
timeFrame: 14 days and 28 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital at Gangdong
state: Gangdong-gu
Study officials:
affiliation: Stroke & Neurological Disorders Center, Kyung Hee University Hospital at Gangdong
name: Seong-Uk Park, KMD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wei JJ, Guo RJ, Fu GJ, Liang X, Xu ZM, Jia M, Zeng ZX, Du WQ, Jiao WW, Sun LJ, Liu HM, Guo CL, Tong CG, Zhang YL, Liao X. Registration of intervention trials of Traditional Chinese Medicine for four neurological diseases on Chinese Clinical Trial Registry and ClinicalTrials.gov: a narrative review. J Tradit Chin Med. 2022 Feb;42(1):148-153. doi: 10.19852/j.cnki.jtcm.2022.01.010.
citation: Lee DH, Cho SY, Yang SB, Lee HM, Shin HS, Lee SH, Koh JS, Kwon S, Jung WS, Moon SK, Park JM, Ko CN, Kim H, Park SU. Efficacy of Acupuncture Treatment to Prevent Cerebral Vasospasm After Subarachnoid Hemorrhage: A Double-Blind, Randomized Placebo-Controlled Trial. J Altern Complement Med. 2020 Dec;26(12):1182-1189. doi: 10.1089/acm.2020.0156. Epub 2020 Sep 1.
citation: Cho SY, Lee DH, Shin HS, Lee SH, Koh JS, Jung WS, Moon SK, Park JM, Ko CN, Kim H, Park SU. The efficacy and safety of acupuncture for cerebral vasospasm after subarachnoid hemorrhage: study protocol for a randomized controlled trial. Trials. 2015 Feb 28;16:68. doi: 10.1186/s13063-015-0591-7.