Acupuncture for Cerebral Vasospasm After Subarachnoid Hemorrhage
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|ClinicalTrials.gov Identifier: NCT02275949|
Recruitment Status : Completed
First Posted : October 27, 2014
Last Update Posted : August 8, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|SAH (Subarachnoid Hemorrhage) Cerebral Vasospasm||Device: acupuncture Device: Electroacupuncture Device: Intradermal acupuncture Device: Mock transcutaneous electrical nerve stimulation Device: sham intradermal acupuncture||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||The Efficacy and Safety of Acupuncture for Cerebral Vasospasm After Subarachnoid Hemorrhage|
|Study Start Date :||September 2014|
|Actual Primary Completion Date :||June 2017|
|Actual Study Completion Date :||June 2017|
Experimental: Study group
acupuncture, electroacupuncture and intradermal acupuncture are done at every session.
Acupuncture needles are inserted at the acupoints Zusanli(ST 36), Neiguan(PC 6), Gongsun(SP 4), and Xiangu(ST 43) bilaterally.
The electric stimulator will be connected to the handles of each needles on the ST 36 and PC 6 bilaterally with 5Hz.
Device: Intradermal acupuncture
Intradermal acupuncture needles with tape are inserted on the ST36, PC6, SP4, ST43 bilaterally and maintained until the next session.
Sham Comparator: Control group
Mock transcutaneous electrical nerve stimulation(mock TENS) and sham intradermal acupuncture are carried out.
Device: Mock transcutaneous electrical nerve stimulation
Electrical insulator are attached on the ST36 and PC6 bilaterally, the same electric stimulator will be connected on the points with the same parameters as the study group, but without current intensity.
Other Name: Mock TENS
Device: sham intradermal acupuncture
Intradermal acupuncture needles are put over the tape not penetrating the skin.
- The occurrence of delayed ischemic neurological deficit [ Time Frame: 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.
- The incidence of angiographic vasospasm [ Time Frame: 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 incidence of TCD vasospasm [ Time Frame: 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 [ Time Frame: 14 days ]It is defined as cerebral infarction in the region of angiographic vasospasm or TCD vasospasm is shown on CT or MRI
- The change of nitric oxide(NO) and endothelin-1 in plasma [ Time Frame: 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.
- Mortality [ Time Frame: 14 days and 28 days ]Mortality at the end of treatment and 14days after the treatment(or at discharge)
- modified Rankin Scale (mRS) [ Time Frame: 14 days and 28 days ]The participan's functional status at the end of treatment and 14days after the treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02275949
|Korea, Republic of|
|Kyung Hee University Hospital at Gangdong|
|Seoul, Gangdong-gu, Korea, Republic of, 05278|
|Principal Investigator:||Seong-Uk Park, KMD, PhD||Stroke & Neurological Disorders Center, Kyung Hee University Hospital at Gangdong|