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

Primary Purpose

Acupuncture, Acute Ischemic Stroke, Mechanical Thrombectomy

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Scalp Acupuncture
The treatment recommended in the guidelines for acute ischemic stroke was administered
Sponsored by
Xi'an No.3 Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acupuncture

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Xi 'an No.3 HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

experimental group

control group

Arm Description

Mechanical thrombectomy was followed by acupuncture and guideline-based conventional treatment

Conventional treatment based on guidelines was administered after mechanical thrombectomy

Outcomes

Primary Outcome Measures

Ratio of Modified rankin scale (mRS) score ≤2
The modified rankin Scale (mRS) score ≤2 indicates that the patient has the ability to live independently.

Secondary Outcome Measures

National Institute of Health stroke scale(NIHSS) score
NIHSS scores range from 0 to 42, with higher scores indicating more severe nerve damage.
Modified rankin scale (mRS) score
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
Incidence of cerebral hemorrhage
No hemorrhage was found on the first head CT/MRI after cerebral infarction, but intracranial hemorrhage was found on the second head CT/MRI

Full Information

First Posted
September 27, 2022
Last Updated
May 11, 2023
Sponsor
Xi'an No.3 Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05561088
Brief Title
Efficacy and Safety of Head Acupuncture After Mechanical Thrombectomy for Acute Ischemic Stroke
Acronym
HEALTH
Official Title
A Single-center, Prospective, Randomized, Controlled Study of Mechanical Thrombectomy Followed by Acupuncture for Acute Ischemic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 27, 2023 (Actual)
Primary Completion Date
February 28, 2026 (Anticipated)
Study Completion Date
October 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xi'an No.3 Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acupuncture, Acute Ischemic Stroke, Mechanical Thrombectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
272 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
experimental group
Arm Type
Experimental
Arm Description
Mechanical thrombectomy was followed by acupuncture and guideline-based conventional treatment
Arm Title
control group
Arm Type
Experimental
Arm Description
Conventional treatment based on guidelines was administered after mechanical thrombectomy
Intervention Type
Other
Intervention Name(s)
Scalp Acupuncture
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
The treatment recommended in the guidelines for acute ischemic stroke was administered
Intervention Description
The treatment recommended in the guidelines for acute ischemic stroke was administered
Primary Outcome Measure Information:
Title
Ratio of Modified rankin scale (mRS) score ≤2
Description
The modified rankin Scale (mRS) score ≤2 indicates that the patient has the ability to live independently.
Time Frame
90 days after onset
Secondary Outcome Measure Information:
Title
National Institute of Health stroke scale(NIHSS) score
Description
NIHSS scores range from 0 to 42, with higher scores indicating more severe nerve damage.
Time Frame
10 days after onset
Title
Modified rankin scale (mRS) score
Description
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
Time Frame
90 days after onset
Title
Incidence of cerebral hemorrhage
Description
No hemorrhage was found on the first head CT/MRI after cerebral infarction, but intracranial hemorrhage was found on the second head CT/MRI
Time Frame
7 days after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shilin L i, Doctor
Phone
8615398076154
Email
lihuashiling@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mingze Chang, Doctor
Phone
8615609250898
Email
cbangingze191@163.com
Facility Information:
Facility Name
Xi 'an No.3 Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710018
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shilin Li, Doctor
Phone
8615398076154
Email
lihuashiling@126.com
First Name & Middle Initial & Last Name & Degree
Mingze Chang, Doctor
Phone
8615609250698
Email
changmingze191@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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