Acupuncture for Cerebral Vasospasm After Subarachnoid Hemorrhage

August 6, 2018 updated by: Seong-Uk Park, Kyung Hee University Hospital at Gangdong

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gangdong-gu
      • Seoul, Gangdong-gu, Korea, Republic of, 05278
        • Kyung Hee University Hospital at Gangdong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of angiographic vasospasm
Time Frame: 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.
14 days
The incidence of TCD vasospasm
Time Frame: 14 days
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
Time Frame: 14 days
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
Time Frame: 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.
14days
Mortality
Time Frame: 14 days and 28 days
Mortality at the end of treatment and 14days after the treatment(or at discharge)
14 days and 28 days
modified Rankin Scale (mRS)
Time Frame: 14 days and 28 days
The participan's functional status at the end of treatment and 14days after the treatment
14 days and 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyung Hee University Hospital at Gangdong

Investigators

  • Principal Investigator: Seong-Uk Park, KMD, PhD, Stroke & Neurological Disorders Center, Kyung Hee University Hospital at Gangdong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

October 23, 2014

First Submitted That Met QC Criteria

October 23, 2014

First Posted (Estimate)

October 27, 2014

Study Record Updates

Last Update Posted (Actual)

August 8, 2018

Last Update Submitted That Met QC Criteria

August 6, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACUSAH20141059

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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