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NCT Number: NCT06941961

iTBS for Acute Ischemic Stroke After Thrombectomy

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.

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Hospital of Jilin University

Changchun, Jilin, 130000, China

Location status: Recruiting

Location contact

Yi Yang, MD, PhD

CONTACT

[email protected]

0086-13756661217

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 90 days

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

Secondary outcomes

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

    Time frame: 90 days

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

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

    Time frame: 30 days

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

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

    Time frame: 7 days

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

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

    Time frame: 7 days

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

  5. All-Cause Mortality Rate at 90 Days

    Time frame: From randomization to 90 days

    Proportion of patients who died from any cause within 90 days.

  6. Incidence of Intracranial Hemorrhage (ICH) and Symptomatic ICH (sICH) During Intervention

    Time frame: 7 days

    ICH is assessed via imaging

  7. Rate of iTBS-Related Adverse Events

    Time frame: From randomization to 90 days

    Includes seizures, headache, scalp discomfort, or other stimulation-related AEs.

  8. Overall Adverse Event (AE) Rate

    Time frame: From randomization to 90 days

    Proportion of patients experiencing any AE during the study.

Study contacts

Contact information is provided by the study sponsor or research team.

Yi Yang, MD, PhD

CONTACT

[email protected]

0086-13756661217

Sponsors and collaborators

Lead sponsor

Yi Yang

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 24, 2025
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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