Ischemic Stroke
Conditions
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.
Interventions
DEVICEintermittent 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-iTBS is performed in the same way as the treatment group but uses 20% RMT.
Sponsors
Yi Yang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| Overall Adverse Event (AE) Rate | From randomization to 90 days | Proportion of patients experiencing any AE during the study. |
| All-Cause Mortality Rate at 90 Days | From randomization to 90 days | Proportion of patients who died from any cause within 90 days. |
Countries
China
Contacts
Primary ContactYi Yang, MD, PhD
Outcome results
None listed