Effects of Transcranial Magnetic Stimulation After Endovascular Treatment for Acute Ischemic Stroke

NCT ID: NCT06639360

Last Updated: 2025-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-02

Study Completion Date

2026-12-31

Brief Summary

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This is a multicenter, randomized, double-blind, sham-controlled trial, to determine the efficacy and safety of cTBS in treating patients with acute ischemic stroke after endovascular treatment.

Detailed Description

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Conditions

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Ischemic Stroke, Acute Endovascular Thrombectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Active-cTBS group

Patients assigned to the Active-cTBS group will be treated with cTBS and usual medical treatment after endovascular treatment

Group Type EXPERIMENTAL

Transcranial Magnetic Stimulation Active

Intervention Type DEVICE

The patients will be treated with cTBS and usual medical treatment after endovascular treatment

Sham-cTBS group

Patients assigned to the Sham-cTBS group will be treated with sham-cTBS and usual medical treatment after endovascular treatment

Group Type SHAM_COMPARATOR

Transcranial Magnetic Stimulation Sham

Intervention Type DEVICE

The patients will be treated with sham-cTBS and usual medical treatment after endovascular treatment

Interventions

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Transcranial Magnetic Stimulation Active

The patients will be treated with cTBS and usual medical treatment after endovascular treatment

Intervention Type DEVICE

Transcranial Magnetic Stimulation Sham

The patients will be treated with sham-cTBS and usual medical treatment after endovascular treatment

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Patients with acute anterior circulation ischemic stroke aged between 18 and 80 years old.
2. Imaging suggests that the infarction is caused by occlusion of the terminal portion of the internal carotid artery or the M1/M2 segment of the middle cerebral artery.
3. A head CT within 24 hours of onset indicates an ASPECT score ≥6, and meets the guideline-recommended criteria for thrombectomy.
4. Pre-stroke mRS score is ≤1.
5. NIHSS score before thrombectomy is between 6 and 25.
6. With vascular recanalization of mTICI \> 2b/3.
7. Informed consent form signed.

Exclusion Criteria

1. Patients with contraindications to TMS treatment, such as those with metallic foreign objects in the head, pacemakers, implantable drug pumps, cochlear implants, etc.;
2. Patients with epilepsy, increased intracranial pressure, tumors, acute cerebral hemorrhage, or other severe neurological diseases, and those with severe functional impairment of organs such as the heart, liver, and kidneys;
3. Head CT/MRI indicates midline shift or significant mass effect, or patients planned for surgical intervention;
4. Head CT/MRI suggests acute cerebral infarction in both sides;
5. Patients who are pregnant or breastfeeding;
6. Patients with severe mental disorders or dementia who cannot cooperate with follow-up;
7. Patients with other severe diseases resulting in an expected survival of less than 90 days;
8. Patients who are participating in other interventional clinical studies within 30 days before the start of this study or after the onset of this condition;
9. Patients who cannot cooperate with informed consent.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Xijing Hospital

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jingjing Zhao, Dr.

Role: CONTACT

+86-29-84775365

Facility Contacts

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Jingjing Zhao, MD

Role: primary

+8618192829590

Other Identifiers

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KY20242288-C-1

Identifier Type: -

Identifier Source: org_study_id

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