iTBS for Acute Ischemic Stroke After Thrombectomy

Yi Yang

Status: Enrolling

Conditions: Ischemic Stroke

Treatments: Device: intermittent theta burst stimulation; Device: sham intermittent theta burst stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06941961

iTBS-ACT

Details and patient eligibility

About

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.

Enrollment: 178 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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178 participants in 2 patient groups

iTBS

Active Comparator group

Description:

Patients are treated with intermittent theta burst stimulation (iTBS).

Treatment:

Device: intermittent theta burst stimulation

sham-iTBS

Sham Comparator group

Description:

Patients are treated with sham intermittent theta burst stimulation (sham-iTBS).

Treatment:

Device: sham intermittent theta burst stimulation