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

Not Applicable

Recruiting

• Conditions: Acute Ischemic Stroke; Mechanical Thrombectomy; Acupuncture
• Interventions: Other: The treatment recommended in the guidelines for acute ischemic stroke was administered; Other: Scalp Acupuncture

• Registration Number: NCT05561088
• Lead Sponsor: 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

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 Timeline

• Study First Submitted: 2022-09-27
• Study First Submitted QC: 2022-09-27
• Study First Posted: 2022-09-30
• Study Start: 2023-04-27
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-11
• Last Update Posted: 2023-05-12
• Primary Completion: 2026-02-28
• Study Completion: 2028-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 272

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	The treatment recommended in the guidelines for acute ischemic stroke was administered	Conventional treatment based on guidelines was administered after mechanical thrombectomy
experimental group	The treatment recommended in the guidelines for acute ischemic stroke was administered	Mechanical thrombectomy was followed by acupuncture and guideline-based conventional treatment
experimental group	Scalp Acupuncture	Mechanical thrombectomy was followed by acupuncture and guideline-based conventional treatment

Primary Outcome Measures

Name	Time	Method
Ratio of Modified rankin scale (mRS) score ≤2	90 days after onset	The modified rankin Scale (mRS) score ≤2 indicates that the patient has the ability to live independently.

Secondary Outcome Measures

Name	Time	Method
Modified rankin scale (mRS) score	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
National Institute of Health stroke scale(NIHSS) score	10 days after onset	NIHSS scores range from 0 to 42, with higher scores indicating more severe nerve damage.
Incidence of cerebral hemorrhage	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

Trial Locations

Locations (1)

Xi 'an No.3 Hospital; 🇨🇳 Xi'an, Shaanxi, China