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SAH (Subarachnoid Hemorrhage)NCT02275949

Acupuncture for Cerebral Vasospasm After Subarachnoid Hemorrhage

A study testing acupuncture, Electroacupuncture and Intradermal acupuncture in people with SAH (Subarachnoid Hemorrhage) and Cerebral Vasospasm, run by Kyung Hee University Hospital at Gangdong at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
acupuncture, Electroacupuncture and Intradermal acupuncture
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
1 siteSouth Korea
Study dates
Sep 2014to Jun 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

South Korea1 site

  • Kyung Hee University Hospital at Gangdong

    Seoul, Gangdong-gu, 05278

Other trials in South Korea

About this study

Official title: 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.

Read the 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.

Being tested
acupuncture, Electroacupuncture, Intradermal acupuncture, Mock transcutaneous electrical nerve stimulation, sham intradermal acupuncture
Keywords
SAH (Subarachnoid Hemorrhage), Cerebral Vasospasm, Acupuncture
Medical subject headings
Subarachnoid Hemorrhage, Vasospasm, Intracranial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • acupunctureDevice

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

  • ElectroacupunctureDevice

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

  • Intradermal acupunctureDevice

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

  • Mock transcutaneous electrical nerve stimulationDevice

    Also called Mock TENS

    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 acupunctureDevice

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

Study groups in NCT02275949
Study groupRoleWhat they receive
Study groupExperimentalacupuncture, electroacupuncture and intradermal acupuncture are done at every session.
Receives: Device: acupuncture; Device: Electroacupuncture; Device: Intradermal acupuncture
Control groupSham comparatorMock transcutaneous electrical nerve stimulation(mock TENS) and sham intradermal acupuncture are carried out.
Receives: Device: Mock transcutaneous electrical nerve stimulation; Device: sham intradermal acupuncture

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 14 days

Secondary outcomes (6)

  1. 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.

    Measured: 14 days

  2. The incidence of TCD vasospasm

    TCD vasospasm is defined as Peak systolic middle cerebral artery velocity > 200cm/s and Lindegaard ratio >3

    Measured: 14 days

  3. 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

    Measured: 14 days

  4. 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.

    Measured: 14days

  5. Mortality

    Mortality at the end of treatment and 14days after the treatment(or at discharge)

    Measured: 14 days and 28 days

  6. modified Rankin Scale (mRS)

    The participan's functional status at the end of treatment and 14days after the treatment

    Measured: 14 days and 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2014 (estimated)
  2. Study startSep 2014
  3. Primary completionJun 2017
  4. Study completionJun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02275949
Sponsor's protocol ID
ACUSAH20141059
Status last verified
Aug 2018
First submitted
23 Oct 2014
Last updated
8 Aug 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Wei JJ, Guo RJ, Fu GJ, Liang X, Xu ZM, Jia M, Zeng ZX, Du WQ, Jiao WW, Sun LJ, Liu HM, Guo CL, Tong CG, Zhang YL, Liao X. Registration of intervention trials of Traditional Chinese Medicine for four neurological diseases on Chinese Clinical Trial Registry and ClinicalTrials.gov: a narrative review. J Tradit Chin Med. 2022 Feb;42(1):148-153. doi: 10.19852/j.cnki.jtcm.2022.01.010.

    PubMed 35294135

  • Lee DH, Cho SY, Yang SB, Lee HM, Shin HS, Lee SH, Koh JS, Kwon S, Jung WS, Moon SK, Park JM, Ko CN, Kim H, Park SU. Efficacy of Acupuncture Treatment to Prevent Cerebral Vasospasm After Subarachnoid Hemorrhage: A Double-Blind, Randomized Placebo-Controlled Trial. J Altern Complement Med. 2020 Dec;26(12):1182-1189. doi: 10.1089/acm.2020.0156. Epub 2020 Sep 1.

    PubMed 32876468

  • Cho SY, Lee DH, Shin HS, Lee SH, Koh JS, Jung WS, Moon SK, Park JM, Ko CN, Kim H, Park SU. The efficacy and safety of acupuncture for cerebral vasospasm after subarachnoid hemorrhage: study protocol for a randomized controlled trial. Trials. 2015 Feb 28;16:68. doi: 10.1186/s13063-015-0591-7.

    PubMed 25886483

Questions about this trial

What is this clinical trial studying?

A study testing acupuncture, Electroacupuncture and Intradermal acupuncture in people with SAH (Subarachnoid Hemorrhage) and Cerebral Vasospasm, run by Kyung Hee University Hospital at Gangdong at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The occurrence of delayed ischemic neurological deficit (time frame: 14 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02275949, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2018.

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