Clinical trial NCT06941961: iTBS for Acute Ischemic Stroke After Thrombectomy
Official title: Efficacy and Safety of Intermittent Theta Burst Stimulation in Acute Anterior Circulation Ischemic Stroke Patients Undergoing Mechanical Thrombectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ischemic Stroke
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2025-04-24
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 outcomes:
measure: Proportion of patients with Modified Rankin Scale (mRS) Score 0-2 at 90 days
timeFrame: 90 days
Secondary outcomes:
measure: Distribution of Modified Rankin Scale (mRS) Scores at 90 Days
timeFrame: 90 days
measure: Distribution of Modified Rankin Scale (mRS) Scores at 30 Days
timeFrame: 30 days
measure: Differences in National Institutes of Health Stroke Scale (NIHSS) Score at 7 days
timeFrame: 7 days
measure: Proportion of Patients with Early Neurological Deterioration (END) Within 7 Days
timeFrame: 7 days
measure: All-Cause Mortality Rate at 90 Days
timeFrame: From randomization to 90 days
measure: Incidence of Intracranial Hemorrhage (ICH) and Symptomatic ICH (sICH) During Intervention
timeFrame: 7 days
measure: Rate of iTBS-Related Adverse Events
timeFrame: From randomization to 90 days
measure: Overall Adverse Event (AE) Rate
timeFrame: From randomization to 90 days
Other outcomes:
Locations:
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
Study officials:
References: