Acupuncture for Cerebral Vasospasm After Subarachnoid Hemorrhage

Sponsor

Kyung Hee University Hospital at Gangdong (Other)

Overall Status

Completed

CT.gov ID

NCT02275949

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

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	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Sep 1, 2014

Actual Primary Completion Date :

Jun 1, 2017

Actual Study Completion Date :

Jun 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Study group acupuncture, electroacupuncture and intradermal acupuncture are done at every session.	Device: acupuncture Acupuncture needles are inserted at the acupoints Zusanli(ST 36), Neiguan(PC 6), Gongsun(SP 4), and Xiangu(ST 43) bilaterally. Device: Electroacupuncture 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 Names: Mock TENS Device: sham intradermal acupuncture Intradermal acupuncture needles are put over the tape not penetrating the skin.

Arm

Intervention/Treatment

Experimental: Study group

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

Device: acupuncture

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

Device: Electroacupuncture

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 Names:

Mock TENS

Device: sham intradermal acupuncture

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

Outcome Measures

Primary Outcome Measures

The occurrence of delayed ischemic neurological deficit [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.

Secondary Outcome Measures

The incidence of angiographic vasospasm [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 [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 [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 [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 [14 days and 28 days]
Mortality at the end of treatment and 14days after the treatment(or at discharge)
modified Rankin Scale (mRS) [14 days and 28 days]
The participan's functional status at the end of treatment and 14days after the treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.