iTBS for Acute Ischemic Stroke After Thrombectomy

NCT ID: NCT06941961

Last Updated: 2025-04-30

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

178 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-25

Study Completion Date

2026-08-01

Brief Summary

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The goal of this randomized, single-blind, parallel-controlled clinical trial is to evaluate the efficacy and safety of intermittent theta burst stimulation (iTBS) as an adjunctive therapy for acute anterior circulation ischemic stroke patients who have undergone successful mechanical thrombectomy (MT). The study population includes adults aged 18-85 with NIHSS scores 5-25 post-MT and eTICI≥2b reperfusion.

Detailed Description

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Conditions

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Ischemic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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iTBS

Patients are treated with intermittent theta burst stimulation (iTBS).

Group Type ACTIVE_COMPARATOR

intermittent theta burst stimulation

Intervention Type DEVICE

The iTBS delivered to the ipsilesional primary motor cortex (M1) at 80% resting motor threshold (RMT). Each session consists of 600 pulses (3-minute trains of 50 Hz triplets repeated every 10 seconds, twice daily with a 5-minute interval), administered for 7 consecutive days starting within 6 hours post-randomization.

sham-iTBS

Patients are treated with sham intermittent theta burst stimulation (sham-iTBS).

Group Type SHAM_COMPARATOR

sham intermittent theta burst stimulation

Intervention Type DEVICE

Sham-iTBS is performed in the same way as the treatment group but uses 20% RMT.

Interventions

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intermittent theta burst stimulation

The iTBS delivered to the ipsilesional primary motor cortex (M1) at 80% resting motor threshold (RMT). Each session consists of 600 pulses (3-minute trains of 50 Hz triplets repeated every 10 seconds, twice daily with a 5-minute interval), administered for 7 consecutive days starting within 6 hours post-randomization.

Intervention Type DEVICE

sham intermittent theta burst stimulation

Sham-iTBS is performed in the same way as the treatment group but uses 20% RMT.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 1\) Age 18-85 years, regardless of gender.
* 2\) Acute ischemic stroke caused by occlusion of the anterior circulation large vessels (internal carotid artery, M1 or M2 segment of the middle cerebral artery), verified by CTA or DSA.
* 3\) Mechanical thrombectomy (MT) performed within 24 hours of symptom onset.
* 4\) Successful Reperfusion: Post-MT eTICI score ≥ 2b.
* 5\) NIHSS score 5-25 at 24 hours post-MT, with ≥2 points in at least one limb.

Exclusion Criteria

* 1\) Pre-stroke modified Rankin Scale (mRS) score ≥2.
* 2\) PH2-type intracranial hemorrhage on brain CT post-MT.
* 3\) Patients who underwent intracranial stent placement during MT.
* 4\) Contraindications to iTBS: History of epilepsy or seizures, implanted cardiac pacemakers, cochlear implants, or other electronic/magnetic-sensitive devices.
* 5\) Severe consciousness impairment, cognitive dysfunction, or psychiatric disorders preventing compliance with iTBS.
* 6\) Expected survival \<3 months due to other medical conditions or inability to complete follow-up for any reason.
* 7\) Participation in another interventional study.
* 8\) Any other condition deemed unsuitable for enrollment by the investigator.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yi Yang

OTHER

Sponsor Role lead

Responsible Party

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Yi Yang

Vice President of First Hospital of Jilin University

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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The First Hospital of Jilin University

Changchun, Jilin, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yi Yang, MD, PhD

Role: CONTACT

0086-13756661217

Facility Contacts

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Yi Yang, MD, PhD

Role: primary

0086-13756661217

Other Identifiers

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iTBS-ACT

Identifier Type: -

Identifier Source: org_study_id

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