Acupuncture for Cerebral Vasospasm After Subarachnoid Hemorrhage

NCT02275949 | Completed DMC

• 1 other identifier: ACUSAH20141059
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

SAH (Subarachnoid Hemorrhage); Cerebral Vasospasm

Keywords

SAH (Subarachnoid Hemorrhage); Cerebral Vasospasm; Acupuncture

Outcome Measures

Primary Outcomes (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.

  14 days

Secondary Outcomes (6)

• The incidence of angiographic vasospasm

  14 days

• The incidence of TCD vasospasm

  14 days

• The incidence of vasospasm-related infarct on CT or MRI

  14 days

• The change of nitric oxide(NO) and endothelin-1 in plasma

  14days

• Mortality

  14 days and 28 days

Study Arms (2)

Study group

EXPERIMENTAL

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

Device: acupuncture; Device: Electroacupuncture; Device: Intradermal acupuncture

Control group

SHAM COMPARATOR

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

Device: Mock transcutaneous electrical nerve stimulation; Device: sham intradermal acupuncture

Interventions

acupuncture DEVICE

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

Study group

Electroacupuncture DEVICE

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

Study group

Intradermal acupuncture DEVICE

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

Study group

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.

Also known as: Mock TENS

Control group

sham intradermal acupuncture DEVICE

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

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kyung Hee University Hospital at Gangdong: lead

Study Sites (1)

Kyung Hee University Hospital at Gangdong

Seoul, Gangdong-gu, 05278, South Korea

Location

Related Publications (3)

• 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.

  PMID: 35294135 DERIVED

• 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.

  PMID: 32876468 DERIVED

• 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.

  PMID: 25886483 DERIVED

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Vasospasm, Intracranial

Interventions

Acupuncture Therapy; Electroacupuncture

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Combined Modality Therapy; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• Seong-Uk Park, KMD, PhD

  Stroke & Neurological Disorders Center, Kyung Hee University Hospital at Gangdong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: A full professor

Study Record Dates

• First Submitted: October 23, 2014
• First Posted: October 27, 2014
• Study Start: September 1, 2014
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: August 8, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)