Using iTBS to treat acute ischemic stroke after thrombectomy

Efficacy and Safety of Intermittent Theta Burst Stimulation in Acute Anterior Circulation Ischemic Stroke Patients Undergoing Mechanical Thrombectomy

This study is testing if a new brain stimulation treatment can help adults recover better after having a stroke and getting a blood clot removed.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 178 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: The First Hospital of Jilin University (Academic / other)
• Locations: 1 site (Changchun, Jilin)
• Trial ID: NCT06941961 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of intermittent theta burst stimulation (iTBS) as an additional therapy for patients who have experienced an acute ischemic stroke and have undergone successful mechanical thrombectomy. The study involves a randomized, single-blind, parallel-controlled design, focusing on adults aged 18-85 with specific NIHSS scores after their procedure. Participants will receive either active iTBS or a sham treatment to assess the potential benefits of this innovative approach in stroke recovery.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-85 who have had an acute ischemic stroke due to large vessel occlusion and have undergone successful mechanical thrombectomy.

Not a fit: Patients with severe pre-existing disabilities, significant cognitive dysfunction, or contraindications to iTBS may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could enhance recovery outcomes for patients suffering from acute ischemic stroke.

How similar studies have performed: While the use of iTBS is a novel approach in this context, similar studies in other neurological conditions have shown promising results.

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.

Where this trial is running

Changchun, Jilin

• The First Hospital of Jilin University — Changchun, Jilin, China (Recruiting)

Study contacts

• Study coordinator: Yi Yang, MD, PhD

Conditions Ischemic Stroke