Acupuncture for Cerebral Vasospasm After Subarachnoid Hemorrhage

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2017-06-30

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.

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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.

Conditions

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SAH (Subarachnoid Hemorrhage) Cerebral Vasospasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Study group

acupuncture, electroacupuncture and intradermal acupuncture are done at every session.

Group Type EXPERIMENTAL

acupuncture

Intervention Type DEVICE

Acupuncture needles are inserted at the acupoints Zusanli(ST 36), Neiguan(PC 6), Gongsun(SP 4), and Xiangu(ST 43) bilaterally.

Electroacupuncture

Intervention Type DEVICE

The electric stimulator will be connected to the handles of each needles on the ST 36 and PC 6 bilaterally with 5Hz.

Intradermal acupuncture

Intervention Type DEVICE

Intradermal acupuncture needles with tape are inserted on the ST36, PC6, SP4, ST43 bilaterally and maintained until the next session.

Control group

Mock transcutaneous electrical nerve stimulation(mock TENS) and sham intradermal acupuncture are carried out.

Group Type SHAM_COMPARATOR

Mock transcutaneous electrical nerve stimulation

Intervention Type DEVICE

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.

sham intradermal acupuncture

Intervention Type DEVICE

Intradermal acupuncture needles are put over the tape not penetrating the skin.

Interventions

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acupuncture

Acupuncture needles are inserted at the acupoints Zusanli(ST 36), Neiguan(PC 6), Gongsun(SP 4), and Xiangu(ST 43) bilaterally.

Intervention Type DEVICE

Electroacupuncture

The electric stimulator will be connected to the handles of each needles on the ST 36 and PC 6 bilaterally with 5Hz.

Intervention Type DEVICE

Intradermal acupuncture

Intradermal acupuncture needles with tape are inserted on the ST36, PC6, SP4, ST43 bilaterally and maintained until the next session.

Intervention Type 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.

Intervention Type DEVICE

sham intradermal acupuncture

Intradermal acupuncture needles are put over the tape not penetrating the skin.

Intervention Type DEVICE

Other Intervention Names

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Mock TENS

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes