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Acupuncture for Cerebral Vasospasm After Subarachnoid Hemorrhage

Primary Purpose

SAH (Subarachnoid Hemorrhage), Cerebral Vasospasm

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
acupuncture
Electroacupuncture
Intradermal acupuncture
Mock transcutaneous electrical nerve stimulation
sham intradermal acupuncture
Sponsored by
Kyung Hee University Hospital at Gangdong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for SAH (Subarachnoid Hemorrhage) focused on measuring SAH (Subarachnoid Hemorrhage), Cerebral Vasospasm, Acupuncture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Kyung Hee University Hospital at Gangdong

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Study group

Control group

Arm Description

acupuncture, electroacupuncture and intradermal acupuncture are done at every session.

Mock transcutaneous electrical nerve stimulation(mock TENS) and sham intradermal acupuncture are carried out.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
The incidence of TCD vasospasm
TCD vasospasm is defined as Peak systolic middle cerebral artery velocity > 200cm/s and Lindegaard ratio >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
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.
Mortality
Mortality at the end of treatment and 14days after the treatment(or at discharge)
modified Rankin Scale (mRS)
The participan's functional status at the end of treatment and 14days after the treatment

Full Information

First Posted
October 23, 2014
Last Updated
August 6, 2018
Sponsor
Kyung Hee University Hospital at Gangdong
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1. Study Identification

Unique Protocol Identification Number
NCT02275949
Brief Title
Acupuncture for Cerebral Vasospasm After Subarachnoid Hemorrhage
Official Title
The Efficacy and Safety of Acupuncture for Cerebral Vasospasm After Subarachnoid Hemorrhage
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyung Hee University Hospital at Gangdong

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SAH (Subarachnoid Hemorrhage), Cerebral Vasospasm
Keywords
SAH (Subarachnoid Hemorrhage), Cerebral Vasospasm, Acupuncture

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Arm Description
acupuncture, electroacupuncture and intradermal acupuncture are done at every session.
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
Mock transcutaneous electrical nerve stimulation(mock TENS) and sham intradermal acupuncture are carried out.
Intervention Type
Device
Intervention Name(s)
acupuncture
Intervention Description
Acupuncture needles are inserted at the acupoints Zusanli(ST 36), Neiguan(PC 6), Gongsun(SP 4), and Xiangu(ST 43) bilaterally.
Intervention Type
Device
Intervention Name(s)
Electroacupuncture
Intervention Description
The electric stimulator will be connected to the handles of each needles on the ST 36 and PC 6 bilaterally with 5Hz.
Intervention Type
Device
Intervention Name(s)
Intradermal acupuncture
Intervention Description
Intradermal acupuncture needles with tape are inserted on the ST36, PC6, SP4, ST43 bilaterally and maintained until the next session.
Intervention Type
Device
Intervention Name(s)
Mock transcutaneous electrical nerve stimulation
Other Intervention Name(s)
Mock TENS
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
sham intradermal acupuncture
Intervention Description
Intradermal acupuncture needles are put over the tape not penetrating the skin.
Primary Outcome Measure Information:
Title
The occurrence of delayed ischemic neurological deficit
Description
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.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
The incidence of angiographic vasospasm
Description
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.
Time Frame
14 days
Title
The incidence of TCD vasospasm
Description
TCD vasospasm is defined as Peak systolic middle cerebral artery velocity > 200cm/s and Lindegaard ratio >3
Time Frame
14 days
Title
The incidence of vasospasm-related infarct on CT or MRI
Description
It is defined as cerebral infarction in the region of angiographic vasospasm or TCD vasospasm is shown on CT or MRI
Time Frame
14 days
Title
The change of nitric oxide(NO) and endothelin-1 in plasma
Description
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.
Time Frame
14days
Title
Mortality
Description
Mortality at the end of treatment and 14days after the treatment(or at discharge)
Time Frame
14 days and 28 days
Title
modified Rankin Scale (mRS)
Description
The participan's functional status at the end of treatment and 14days after the treatment
Time Frame
14 days and 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seong-Uk Park, KMD, PhD
Organizational Affiliation
Stroke & Neurological Disorders Center, Kyung Hee University Hospital at Gangdong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kyung Hee University Hospital at Gangdong
City
Seoul
State/Province
Gangdong-gu
ZIP/Postal Code
05278
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35294135
Citation
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.
Results Reference
derived
PubMed Identifier
32876468
Citation
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.
Results Reference
derived
PubMed Identifier
25886483
Citation
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.
Results Reference
derived

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Acupuncture for Cerebral Vasospasm After Subarachnoid Hemorrhage

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