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

May 11, 2023 updated by: Xi'an No.3 Hospital

A Single-center, Prospective, Randomized, Controlled Study of Mechanical Thrombectomy Followed by Acupuncture for Acute Ischemic Stroke

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

272

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710018

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
90 days after onset

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 days after onset
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
90 days after onset
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
7 days after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xi'an No.3 Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 27, 2023

Primary Completion (Anticipated)

February 28, 2026

Study Completion (Anticipated)

October 31, 2028

Study Registration Dates

First Submitted

September 27, 2022

First Submitted That Met QC Criteria

September 27, 2022

First Posted (Actual)

September 30, 2022

Study Record Updates

Last Update Posted (Actual)

May 12, 2023

Last Update Submitted That Met QC Criteria

May 11, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • sy-11-2022-124

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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