NCT05561088

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
272

participants targeted

Target at P75+ for not_applicable

Timeline
30mo left

Started Apr 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress55%
Apr 2023Oct 2028

First Submitted

Initial submission to the registry

September 27, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 30, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

April 27, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2028

Expected
Last Updated

May 12, 2023

Status Verified

May 1, 2023

Enrollment Period

2.8 years

First QC Date

September 27, 2022

Last Update Submit

May 11, 2023

Conditions

AcupunctureAcute Ischemic StrokeMechanical Thrombectomy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • National Institute of Health stroke scale(NIHSS) score

    10 days after onset

  • Modified rankin scale (mRS) score

    90 days after onset

  • Incidence of cerebral hemorrhage

    7 days after randomization

Study Arms (2)

experimental group

EXPERIMENTAL

Mechanical thrombectomy was followed by acupuncture and guideline-based conventional treatment

Other: Scalp AcupunctureOther: The treatment recommended in the guidelines for acute ischemic stroke was administered

control group

EXPERIMENTAL

Conventional treatment based on guidelines was administered after mechanical thrombectomy

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

Interventions

Scalp AcupunctureOTHER

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.

experimental group
The treatment recommended in the guidelines for acute ischemic stroke was administeredOTHER

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

control groupexperimental group

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years;
  • Patients with acute ischemic stroke who received endovascular treatment within 24 hours of onset;
  • \< NIHSS ≤25;
  • ASPECT score ≥6 points;
  • Signed Informed consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xi 'an No.3 Hospital

Xi'an, Shaanxi, 710018, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Shilin L i, Doctor

CONTACT

8615398076154lihuashiling@126.com

Mingze Chang, Doctor

CONTACT

8615609250898cbangingze191@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2022

First Posted

September 30, 2022

Study Start

April 27, 2023

Primary Completion

February 28, 2026

Study Completion (Estimated)

October 31, 2028

Last Updated

May 12, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)