Acupuncture for Cerebral Vasospasm After Subarachnoid Hemorrhage

Kyung Hee University

Status: Completed

Conditions: SAH (Subarachnoid Hemorrhage); Cerebral Vasospasm

Treatments: Device: Intradermal acupuncture; Device: Electroacupuncture; Device: sham intradermal acupuncture; Device: acupuncture; Device: Mock transcutaneous electrical nerve stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02275949

ACUSAH20141059

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Study group

Experimental group

Description:

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

Treatment:

Device: acupuncture

Device: Electroacupuncture

Device: Intradermal acupuncture

Control group

Sham Comparator group

Description:

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

Treatment:

Device: Mock transcutaneous electrical nerve stimulation

Device: sham intradermal acupuncture