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

Overview

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

• Device intermittent 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.
• Device sham intermittent theta burst stimulation
  Sham-iTBS is performed in the same way as the treatment group but uses 20% RMT.

Primary outcome measures

• Proportion of patients with Modified Rankin Scale (mRS) Score 0-2 at 90 days [Time frame: 90 days]

Secondary outcome measures (8)

• Distribution of Modified Rankin Scale (mRS) Scores at 90 Days [Time frame: 90 days]
• Distribution of Modified Rankin Scale (mRS) Scores at 30 Days [Time frame: 30 days]
• Differences in National Institutes of Health Stroke Scale (NIHSS) Score at 7 days [Time frame: 7 days]
• Proportion of Patients with Early Neurological Deterioration (END) Within 7 Days [Time frame: 7 days]
• All-Cause Mortality Rate at 90 Days [Time frame: From randomization to 90 days]
• Incidence of Intracranial Hemorrhage (ICH) and Symptomatic ICH (sICH) During Intervention [Time frame: 7 days]
• Rate of iTBS-Related Adverse Events [Time frame: From randomization to 90 days]
• Overall Adverse Event (AE) Rate [Time frame: From randomization to 90 days]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

China · 1 center

• The First Hospital of Jilin University — Changchun

Identifiers

NCT: NCT06941961 · iTBS-ACT

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗