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iTBS for Acute Ischemic Stroke After Thrombectomy

ConditionIschemic Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorYi Yang

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • intermittent theta burst stimulation

    Device

    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 intermittent theta burst stimulation

    Device

    Sham-iTBS is performed in the same way as the treatment group but uses 20% RMT.

Treatment groups

178 Participants
are divided into 2 treatment groups
Group A: iTBSActive comparator 1 intervention
Group B: sham-iTBSSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of patients with Modified Rankin Scale (mRS) Score 0-2 at 90 days

Modified Rankin Scale (mRS) ranged from 0 to 6, a low value represents a better outcome.

Time frame
90 days

Secondary outcomes

1

Distribution of Modified Rankin Scale (mRS) Scores at 90 Days

mRS scores (0-6) assess functional independence, where lower scores indicate better outcomes.

Time frame
90 days
2

Distribution of Modified Rankin Scale (mRS) Scores at 30 Days

mRS scores (0-6) assess functional independence, where lower scores indicate better outcomes.

Time frame
30 days
3

Differences in National Institutes of Health Stroke Scale (NIHSS) Score at 7 days

NIHSS (0-42) measures neurological deficit severity, with lower scores indicating better function.

Time frame
7 days
4

Proportion of Patients with Early Neurological Deterioration (END) Within 7 Days

END is defined as an increase in NIHSS score ≥4 points from baseline.

Time frame
7 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yi Yang

Lead sponsor

The First Hospital of Jilin University

Sponsor institution

Source ClinicalTrials.gov
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