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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05561088
Acronym
HEALTH
Enrollment
272
Registered
2022-09-30
Start date
2023-04-27
Completion date
2028-10-31
Last updated
2023-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acupuncture, Acute Ischemic Stroke, Mechanical Thrombectomy

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

Interventions

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.

OTHERThe treatment recommended in the guidelines for acute ischemic stroke was administered

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

Sponsors

Xi'an No.3 Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Ratio of Modified rankin scale (mRS) score ≤290 days after onsetThe modified rankin Scale (mRS) score ≤2 indicates that the patient has the ability to live independently.

Secondary

MeasureTime frameDescription
National Institute of Health stroke scale(NIHSS) score10 days after onsetNIHSS scores range from 0 to 42, with higher scores indicating more severe nerve damage.
Modified rankin scale (mRS) score90 days after onsetModified 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 hemorrhage7 days after randomizationNo hemorrhage was found on the first head CT/MRI after cerebral infarction, but intracranial hemorrhage was found on the second head CT/MRI

Countries

China

Contacts

Primary ContactShilin L i, Doctor
lihuashiling@126.com8615398076154
Backup ContactMingze Chang, Doctor
cbangingze191@163.com8615609250898

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026