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Recruiting Not applicable

iTBS for Acute Ischemic Stroke After Thrombectomy

NCT06941961 · tracked via the Priya Life Science China tracker
Sponsor
Phase
Not applicable
Started
2025-04-25
Last updated
2025-04-30

Condition(s) studied

Ischemic Stroke

Investigational drug(s) / intervention(s)

intermittent theta burst stimulationsham intermittent theta burst stimulation

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.

sham intermittent theta burst stimulation: Sham-iTBS is performed in the same way as the treatment group but uses 20% RMT.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Proportion of patients with Modified Rankin Scale (mRS) Score 0-2 at 90 days — 90 days
    Modified Rankin Scale (mRS) ranged from 0 to 6, a low value represents a better outcome.

Trial sites (1)

FacilityCityRegionStatus
The First Hospital of Jilin University Changchun Jilin Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06941961 on ClinicalTrials.gov ↗ ← All trials in China