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Acupuncture for Cerebral Vasospasm After Subarachnoid Hemorrhage

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ClinicalTrials.gov Identifier: NCT02275949
Recruitment Status : Completed
First Posted : October 27, 2014
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Seong-Uk Park, Kyung Hee University Hospital at Gangdong

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 Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
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 : September 2014
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture Bleeding

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 Name: Mock TENS

Device: sham intradermal acupuncture
Intradermal acupuncture needles are put over the tape not penetrating the skin.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02275949


Locations
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Korea, Republic of
Kyung Hee University Hospital at Gangdong
Seoul, Gangdong-gu, Korea, Republic of, 05278
Sponsors and Collaborators
Kyung Hee University Hospital at Gangdong
Investigators
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Principal Investigator: Seong-Uk Park, KMD, PhD Stroke & Neurological Disorders Center, Kyung Hee University Hospital at Gangdong

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Seong-Uk Park, A full professor, Kyung Hee University Hospital at Gangdong
ClinicalTrials.gov Identifier: NCT02275949     History of Changes
Other Study ID Numbers: ACUSAH20141059
First Posted: October 27, 2014    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Seong-Uk Park, Kyung Hee University Hospital at Gangdong:
SAH (Subarachnoid Hemorrhage)
Cerebral Vasospasm
Acupuncture
Additional relevant MeSH terms:
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Subarachnoid Hemorrhage
Vasospasm, Intracranial
Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases