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Efficacy and Safety of Head Acupuncture After Mechanical Thrombectomy for Acute Ischemic Stroke (HEALTH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05561088
Recruitment Status : Not yet recruiting
First Posted : September 30, 2022
Last Update Posted : October 26, 2022
Sponsor:
Information provided by (Responsible Party):
Xi'an No.3 Hospital

Brief Summary:
To evaluate the efficacy and safety of head acupuncture combined with endovascular therapy for cerebral infarction compared with endovascular therapy alone

Condition or disease Intervention/treatment Phase
Acupuncture Acute Ischemic Stroke Mechanical Thrombectomy Other: Scalp Acupuncture Other: The treatment recommended in the guidelines for acute ischemic stroke was administered Not Applicable

Detailed Description:

Control group: Mechanical thrombectomy followed by the guideline recommended treatment for acute ischemic stroke;

Experimental group: After mechanical thrombectomy, head acupuncture and the treatment regimen recommended by the guideline for acute ischemic stroke were administered

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 272 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-center, Prospective, Randomized, Controlled Study of Mechanical Thrombectomy Followed by Acupuncture for Acute Ischemic Stroke
Estimated Study Start Date : December 31, 2022
Estimated Primary Completion Date : September 30, 2025
Estimated Study Completion Date : October 31, 2028

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: experimental group
Mechanical thrombectomy was followed by acupuncture and guideline-based conventional treatment
Other: Scalp Acupuncture
mplementation plan of head needle: The middle frontal line (MS1), the middle parietal line (MS5) and the back parietal and temporal oblique line (MS7) in the International Standardization Program for the Name of the first needle Point in 1989 were selected, and the needles were inserted along the shape of each section. One needle was inserted into the middle frontal line and the middle parietal line, and two needles were inserted into the back parietal and temporal oblique line. The KWD-808I pulse electrotherapy instrument produced by Changzhou Wujin Great Wall Medical Equipment Co., Ltd. is used on the needle handle after lifting, inserting and twisting. The continuous waveform was used, the voltage was 2-4 V, the frequency was 60-80 times /min, the intensity was tolerated by the patient, the needle was kept for 30min, and the treatment was performed once a day.

Other: The treatment recommended in the guidelines for acute ischemic stroke was administered
The treatment recommended in the guidelines for acute ischemic stroke was administered

Experimental: control group
Conventional treatment based on guidelines was administered after mechanical thrombectomy
Other: The treatment recommended in the guidelines for acute ischemic stroke was administered
The treatment recommended in the guidelines for acute ischemic stroke was administered




Primary Outcome Measures :
  1. Ratio of Modified rankin scale (mRS) score ≤2 [ Time Frame: 90 days after onset ]
    The modified rankin Scale (mRS) score ≤2 indicates that the patient has the ability to live independently.


Secondary Outcome Measures :
  1. National Institute of Health stroke scale(NIHSS) score [ Time Frame: 10 days after onset ]
    NIHSS scores range from 0 to 42, with higher scores indicating more severe nerve damage.

  2. Modified rankin scale (mRS) score [ Time Frame: 90 days after onset ]
    Modified rankin scale (mRS) Score is used to measure the neurological function recovery status of patients after stroke, and its score ranges from 0 to 6

  3. Incidence of cerebral hemorrhage [ Time Frame: 7 days after randomization ]
    No hemorrhage was found on the first head CT/MRI after cerebral infarction, but intracranial hemorrhage was found on the second head CT/MRI



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥18 years;
  • Patients with acute ischemic stroke who received endovascular treatment within 24 hours of onset;
  • 6 < NIHSS ≤25;
  • ASPECT score ≥6 points;
  • Signed Informed consent.

Exclusion Criteria:

  • CT or brain MRI confirmed intracranial tumor and intracranial hemorrhage;
  • Contraindications of contrast media;
  • Dementia or mental illness,unable to cooperate with treatment and follow-up;
  • The expected survival time was less than 3 months;
  • Women who are pregnant, planning to become pregnant or breastfeeding;
  • Currently participating in other clinical trials.

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): NCT05561088


Contacts
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Contact: Shilin L i, Doctor 8615398076154 lihuashiling@126.com
Contact: Yong Zhao, Doctor 8618209278351 13289867381@163.com

Locations
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China, Shaanxi
Xi 'an No.3 Hospital
Xi'an, Shaanxi, China, 710018
Contact: Shilin Li, Doctor    8615398076154    lihuashiling@126.com   
Contact: Yong Zhao, Doctor    8618202978351    13289867381@163.com   
Sponsors and Collaborators
Xi'an No.3 Hospital
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Responsible Party: Xi'an No.3 Hospital
ClinicalTrials.gov Identifier: NCT05561088    
Other Study ID Numbers: sy-11-2022-124
First Posted: September 30, 2022    Key Record Dates
Last Update Posted: October 26, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Infarction
Necrosis