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NCT Number: NCT05561088

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

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

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Key information

Conditions

Acupuncture Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Mechanical Thrombectomy Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Scalp Acupuncture

Other

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

Other

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

Primary outcomes

  1. Ratio of Modified rankin scale (mRS) score ≤2

    Time frame: 90 days after onset

    The modified rankin Scale (mRS) score ≤2 indicates that the patient has the ability to live independently.

Secondary outcomes

  1. National Institute of Health stroke scale(NIHSS) score

    Time frame: 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

    Time frame: 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

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Mingze Chang, Doctor

CONTACT

[email protected]

8615609250898

Shilin L i, Doctor

CONTACT

[email protected]

8615398076154

Sponsors and collaborators

Lead sponsor

Xi'an No.3 Hospital

Other Gov

Registry information

Official study title

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

Acronym: HEALTH

Important dates

Study start
2023
Primary completion
2026
Study completion
2028
First posted
Sep 30, 2022
Registry last updated
May 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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