Acupuncture for Cerebral Vasospasm After Subarachnoid Hemorrhage

Cerebral Vasospasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02275949
• Other study ID #: ACUSAH20141059
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: June 2017

Study information

• Verified date: August 2018
• Source: Kyung Hee University Hospital at Gangdong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Vasospasm
• Hemorrhage
• SAH (Subarachnoid Hemorrhage)
• Subarachnoid Hemorrhage
• Vasospasm, Intracranial

Intervention

Device:
• acupuncture
Acupuncture needles are inserted at the acupoints Zusanli(ST 36), Neiguan(PC 6), Gongsun(SP 4), and Xiangu(ST 43) bilaterally.
• Electroacupuncture
The electric stimulator will be connected to the handles of each needles on the ST 36 and PC 6 bilaterally with 5Hz.
• Intradermal acupuncture
Intradermal acupuncture needles with tape are inserted on the ST36, PC6, SP4, ST43 bilaterally and maintained until the next session.
• 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.
• sham intradermal acupuncture
Intradermal acupuncture needles are put over the tape not penetrating the skin.

Locations

Country	Name	City	State
Korea, Republic of	Kyung Hee University Hospital at Gangdong	Seoul	Gangdong-gu

Sponsors (1)

Lead Sponsor	Collaborator
Kyung Hee University Hospital at Gangdong

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	The incidence of TCD vasospasm	TCD vasospasm is defined as Peak systolic middle cerebral artery velocity > 200cm/s and Lindegaard ratio >3	14 days
Secondary	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
Secondary	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
Secondary	Mortality	Mortality at the end of treatment and 14days after the treatment(or at discharge)	14 days and 28 days
Secondary	modified Rankin Scale (mRS)	The participan's functional status at the end of treatment and 14days after the treatment	14 days and 28 days