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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iTBS | Active Comparator | Patients are treated with intermittent theta burst stimulation (iTBS). |
|
| sham-iTBS | Sham Comparator | Patients are treated with sham intermittent theta burst stimulation (sham-iTBS). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Distribution of Modified Rankin Scale (mRS) Scores at 90 Days | mRS scores (0-6) assess functional independence, where lower scores indicate better outcomes. | 90 days |
| Distribution of Modified Rankin Scale (mRS) Scores at 30 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi Yang, MD, PhD | Contact | 0086-13756661217 | doctor_yangyi@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of Jilin University | Recruiting | Changchun | Jilin | 130000 | China |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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|
| sham intermittent theta burst stimulation | Device | Sham-iTBS is performed in the same way as the treatment group but uses 20% RMT. |
|
mRS scores (0-6) assess functional independence, where lower scores indicate better outcomes.
| 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. | 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. | 7 days |
| All-Cause Mortality Rate at 90 Days | Proportion of patients who died from any cause within 90 days. | From randomization to 90 days |
| Incidence of Intracranial Hemorrhage (ICH) and Symptomatic ICH (sICH) During Intervention | ICH is assessed via imaging | 7 days |
| Rate of iTBS-Related Adverse Events | Includes seizures, headache, scalp discomfort, or other stimulation-related AEs. | From randomization to 90 days |
| Overall Adverse Event (AE) Rate | Proportion of patients experiencing any AE during the study. | From randomization to 90 days |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |