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

Acute Ischemic Stroke Clinical Trial

— HEALTH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05561088
• Other study ID #: sy-11-2022-124
• Status: Recruiting
• Phase: N/A
• Start date: April 27, 2023
• Est. completion date: October 31, 2028

Study information

• Verified date: May 2023
• Source: Xi'an No.3 Hospital
• Contact: Shilin L i, Doctor
• Phone: 8615398076154
• Email: lihuashiling[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 272
• Est. completion date: October 31, 2028
• Est. primary completion date: February 28, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acupuncture
• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Mechanical Thrombectomy
• Stroke

Intervention

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.
• The treatment recommended in the guidelines for acute ischemic stroke was administered
The treatment recommended in the guidelines for acute ischemic stroke was administered

Locations

Country	Name	City	State
China	Xi 'an No.3 Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xi'an No.3 Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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