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Completed

NCT Number: NCT02275949

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.

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Key information

Conditions

SAH (Subarachnoid Hemorrhage) Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Vasospasm Cerebrovascular Disorders Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Subarachnoid Hemorrhage Vascular Diseases Vasospasm, Intracranial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kyung Hee University Hospital at Gangdong

Seoul, Gangdong-gu, 05278, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

acupuncture

Device

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

Electroacupuncture

Device

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

Intradermal acupuncture

Device

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

Device

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

sham intradermal acupuncture

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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.

  5. Mortality

    Time frame: 14 days and 28 days

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

  6. 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

Sponsors and collaborators

Lead sponsor

Kyung Hee University Hospital at Gangdong

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Oct 27, 2014
Registry last updated
Aug 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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