iTBS for Acute Ischemic Stroke After Thrombectomy

NCT06941961 | Recruiting

• 1 other identifier: iTBS-ACT
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with Modified Rankin Scale (mRS) Score 0-2 at 90 days

  Modified Rankin Scale (mRS) ranged from 0 to 6, a low value represents a better outcome.

  90 days

Secondary Outcomes (8)

• Distribution of Modified Rankin Scale (mRS) Scores at 90 Days

  90 days

• Distribution of Modified Rankin Scale (mRS) Scores at 30 Days

  30 days

• Differences in National Institutes of Health Stroke Scale (NIHSS) Score at 7 days

  7 days

• Proportion of Patients with Early Neurological Deterioration (END) Within 7 Days

  7 days

• All-Cause Mortality Rate at 90 Days

  From randomization to 90 days

Study Arms (2)

iTBS

ACTIVE COMPARATOR

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

Device: intermittent theta burst stimulation

sham-iTBS

SHAM COMPARATOR

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

Device: sham intermittent theta burst stimulation

Interventions

intermittent theta burst stimulation 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.

iTBS

sham intermittent theta burst stimulation DEVICE

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

sham-iTBS

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) Age 18-85 years, regardless of gender.
• \) 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.
• \) Mechanical thrombectomy (MT) performed within 24 hours of symptom onset.
• \) Successful Reperfusion: Post-MT eTICI score ≥ 2b.
• \) NIHSS score 5-25 at 24 hours post-MT, with ≥2 points in at least one limb.

You may not qualify if:

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

Sponsors & Collaborators

• Yi Yang: lead

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, 130000, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Yi Yang, MD, PhD

CONTACT

0086-13756661217; doctor_yangyi@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice President of First Hospital of Jilin University

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: April 24, 2025
• Study Start: April 25, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 30, 2025

Record last verified: 2025-04

Locations

CN (1)