iTBS for Acute Ischemic Stroke After Thrombectomy

Not Applicable

Recruiting

• Conditions: Ischemic Stroke

• Registration Number: NCT06941961
• Lead Sponsor: Yi Yang

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-15
• Study First Submitted QC: 2025-04-22
• Study First Posted: 2025-04-24
• Study Start: 2025-04-25
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-04-30
• Primary Completion: 2026-07-01
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 178

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Proportion of Patients with Early Neurological Deterioration (END) Within 7 Days	7 days	END is defined as an increase in NIHSS score ≥4 points from baseline.
All-Cause Mortality Rate at 90 Days	From randomization to 90 days	Proportion of patients who died from any cause within 90 days.
Overall Adverse Event (AE) Rate	From randomization to 90 days	Proportion of patients experiencing any AE during the study.
Distribution of Modified Rankin Scale (mRS) Scores at 90 Days	90 days	mRS scores (0-6) assess functional independence, where lower scores indicate better outcomes.
Distribution of Modified Rankin Scale (mRS) Scores at 30 Days	30 days	mRS scores (0-6) assess functional independence, where lower scores indicate better outcomes.
Differences in National Institutes of Health Stroke Scale (NIHSS) Score at 7 days	7 days	NIHSS (0-42) measures neurological deficit severity, with lower scores indicating better function.
Incidence of Intracranial Hemorrhage (ICH) and Symptomatic ICH (sICH) During Intervention	7 days	ICH is assessed via imaging
Rate of iTBS-Related Adverse Events	From randomization to 90 days	Includes seizures, headache, scalp discomfort, or other stimulation-related AEs.

Trial Locations

Locations (1)

The First Hospital of Jilin University; 🇨🇳 Changchun, Jilin, China