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

• Sponsor: Xi'an No.3 Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05561088
• Collaborator: (none)
• Enrollment: 272
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 70
• Patients Per Site Per Month: 3.9

Study Details

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

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	N/A

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 Design

• Study Type: Interventional
• Anticipated 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
• Anticipated Study Start Date: Dec 31, 2022
• Anticipated Primary Completion Date: Sep 30, 2025
• Anticipated Study Completion Date: Oct 31, 2028

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Xi 'an No.3 Hospital	Xi'an	Shaanxi	China	710018

Sponsors and Collaborators

• Xi'an No.3 Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xi'an No.3 Hospital
• ClinicalTrials.gov Identifier: NCT05561088
• Other Study ID Numbers: sy-11-2022-124
• First Posted: Sep 30, 2022
• Last Update Posted: Oct 26, 2022
• Last Verified: Oct 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia

Study Results

No Results Posted as of Oct 26, 2022