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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
178
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 is performed in the same way as the treatment group but uses 20% RMT.
The First Hospital of Jilin University
Changchun, Jilin, China
RECRUITINGProportion 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.
Time frame: 90 days
Distribution of Modified Rankin Scale (mRS) Scores at 90 Days
mRS scores (0-6) assess functional independence, where lower scores indicate better outcomes.
Time frame: 90 days
Distribution of Modified Rankin Scale (mRS) Scores at 30 Days
mRS scores (0-6) assess functional independence, where lower scores indicate better outcomes.
Time frame: 30 days
Differences in National Institutes of Health Stroke Scale (NIHSS) Score at 7 days
NIHSS (0-42) measures neurological deficit severity, with lower scores indicating better function.
Time frame: 7 days
Proportion of Patients with Early Neurological Deterioration (END) Within 7 Days
END is defined as an increase in NIHSS score ≥4 points from baseline.
Time frame: 7 days
All-Cause Mortality Rate at 90 Days
Proportion of patients who died from any cause within 90 days.
Time frame: From randomization to 90 days
Incidence of Intracranial Hemorrhage (ICH) and Symptomatic ICH (sICH) During Intervention
ICH is assessed via imaging
Time frame: 7 days
Rate of iTBS-Related Adverse Events
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Includes seizures, headache, scalp discomfort, or other stimulation-related AEs.
Time frame: From randomization to 90 days
Overall Adverse Event (AE) Rate
Proportion of patients experiencing any AE during the study.
Time frame: From randomization to 90 days