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

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

Detailed Description
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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

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

Conditions
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Acupuncture, Acute Ischemic Stroke, Mechanical Thrombectomy

Intervention / Treatment
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* Other: Scalp Acupuncture
* Other: The treatment recommended in the guidelines for acute ischemic stroke was administered


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br>Mechanical thrombectomy was followed by acupuncture and guideline-based conventional treatment | Other: Scalp Acupuncture<br>* 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.<br>Other: The treatment recommended in the guidelines for acute ischemic stroke was administered<br>* The treatment recommended in the guidelines for acute ischemic stroke was administered<br>|
| Experimental: control group<br>Conventional treatment based on guidelines was administered after mechanical thrombectomy | Other: The treatment recommended in the guidelines for acute ischemic stroke was administered<br>* The treatment recommended in the guidelines for acute ischemic stroke was administered<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 90 days after onset | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| National Institute of Health stroke scale(NIHSS) score | NIHSS scores range from 0 to 42, with higher scores indicating more severe nerve damage. | 10 days after onset | 
| 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 | 90 days after onset | 
| 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 | 7 days after randomization |