iTBS for Acute Ischemic Stroke After Thrombectomy

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

Study Overview

• Status: Recruiting
• Conditions: Ischemic Stroke
• Intervention / Treatment: Device: intermittent theta burst stimulation; Device: sham intermittent theta burst stimulation

• Study Type: Interventional
• Enrollment (Estimated): 178
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yi Yang, MD, PhD; Phone Number: 0086-13756661217; Email: doctor_yangyi@163.com

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130000
      • Recruiting
      • The First Hospital of Jilin University
      • Contact: Yi Yang, MD, PhD; Phone Number: 0086-13756661217; Email: doctor_yangyi@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: iTBS; Patients are treated with intermittent theta burst stimulation (iTBS).	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.
Sham Comparator: sham-iTBS; Patients are treated with sham intermittent theta burst stimulation (sham-iTBS).	Device: sham intermittent theta burst stimulation; Sham-iTBS is performed in the same way as the treatment group but uses 20% RMT.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distribution of Modified Rankin Scale (mRS) Scores at 90 Days	mRS scores (0-6) assess functional independence, where lower scores indicate better outcomes.	90 days
Distribution of Modified Rankin Scale (mRS) Scores at 30 Days	mRS scores (0-6) assess functional independence, where lower scores indicate better outcomes.	30 days
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.	7 days
Proportion of Patients with Early Neurological Deterioration (END) Within 7 Days	END is defined as an increase in NIHSS score ≥4 points from baseline.	7 days
All-Cause Mortality Rate at 90 Days	Proportion of patients who died from any cause within 90 days.	From randomization to 90 days
Incidence of Intracranial Hemorrhage (ICH) and Symptomatic ICH (sICH) During Intervention	ICH is assessed via imaging	7 days
Rate of iTBS-Related Adverse Events	Includes seizures, headache, scalp discomfort, or other stimulation-related AEs.	From randomization to 90 days
Overall Adverse Event (AE) Rate	Proportion of patients experiencing any AE during the study.	From randomization to 90 days

Collaborators and Investigators

• Sponsor: Yi Yang

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: April 15, 2025
• First Submitted That Met QC Criteria: April 22, 2025
• First Posted (Actual): April 24, 2025

Study Record Updates

• Last Update Posted (Actual): April 30, 2025
• Last Update Submitted That Met QC Criteria: April 28, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Brain Infarction; Brain Ischemia; Infarction; Necrosis; Ischemic Stroke; Stroke; Cerebral Infarction; Ischemia
• Other Study ID Numbers: iTBS-ACT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No