Acupuncture for Cerebral Vasospasm After Subarachnoid Hemorrhage

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Efficacy and Safety of Acupuncture for Cerebral Vasospasm After Subarachnoid Hemorrhage

Conditions
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SAH (Subarachnoid Hemorrhage), Cerebral Vasospasm

Intervention / Treatment
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* Device: acupuncture
* Device: Electroacupuncture
* Device: Intradermal acupuncture
* Device: Mock transcutaneous electrical nerve stimulation
* Device: sham intradermal acupuncture


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>acupuncture, electroacupuncture and intradermal acupuncture are done at every session. | Device: acupuncture<br>* Acupuncture needles are inserted at the acupoints Zusanli(ST 36), Neiguan(PC 6), Gongsun(SP 4), and Xiangu(ST 43) bilaterally.<br>Device: Electroacupuncture<br>* The electric stimulator will be connected to the handles of each needles on the ST 36 and PC 6 bilaterally with 5Hz.<br>Device: Intradermal acupuncture<br>* Intradermal acupuncture needles with tape are inserted on the ST36, PC6, SP4, ST43 bilaterally and maintained until the next session.<br>|
| Sham Comparator: Control group<br>Mock transcutaneous electrical nerve stimulation(mock TENS) and sham intradermal acupuncture are carried out. | Device: Mock transcutaneous electrical nerve stimulation<br>* 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.<br>* Other names: Mock TENS;Device: sham intradermal acupuncture<br>* Intradermal acupuncture needles are put over the tape not penetrating the skin.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The occurrence of delayed ischemic neurological deficit | 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. | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of angiographic vasospasm | 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. | 14 days | 
| The incidence of TCD vasospasm | TCD vasospasm is defined as Peak systolic middle cerebral artery velocity > 200cm/s and Lindegaard ratio >3 | 14 days | 
| The incidence of vasospasm-related infarct on CT or MRI | It is defined as cerebral infarction in the region of angiographic vasospasm or TCD vasospasm is shown on CT or MRI | 14 days | 
| The change of nitric oxide(NO) and endothelin-1 in plasma | 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. | 14days | 
| Mortality | Mortality at the end of treatment and 14days after the treatment(or at discharge) | 14 days and 28 days | 
| modified Rankin Scale (mRS) | The participan's functional status at the end of treatment and 14days after the treatment | 14 days and 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SAH (Subarachnoid Hemorrhage), Cerebral Vasospasm, Acupuncture