Effects of Transcranial Magnetic Stimulation After Endovascular Treatment for Acute Ischemic Stroke

This is a multicenter, randomized, double-blind, sham-controlled trial, to determine the efficacy and safety of cTBS in treating patients with acute ischemic stroke after endovascular treatment.

Study Overview

• Status: Recruiting
• Conditions: Ischemic Stroke, Acute; Endovascular Thrombectomy
• Intervention / Treatment: Device: Transcranial Magnetic Stimulation Active; Device: Transcranial Magnetic Stimulation Sham

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jingjing Zhao, Dr.; Phone Number: +86-29-84775365; Email: zhaojing0110@126.com

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Recruiting
      • Xijing Hospital
      • Contact: Jingjing Zhao, MD; Phone Number: +8618192829590; Email: zhaojing0110@126.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Patients with acute anterior circulation ischemic stroke aged between 18 and 80 years old.
2. Imaging suggests that the infarction is caused by occlusion of the terminal portion of the internal carotid artery or the M1/M2 segment of the middle cerebral artery.
3. A head CT within 24 hours of onset indicates an ASPECT score ≥6, and meets the guideline-recommended criteria for thrombectomy.
4. Pre-stroke mRS score is ≤1.
5. NIHSS score before thrombectomy is between 6 and 25.
6. With vascular recanalization of mTICI > 2b/3.
7. Informed consent form signed.

Exclusion Criteria:

1. Patients with contraindications to TMS treatment, such as those with metallic foreign objects in the head, pacemakers, implantable drug pumps, cochlear implants, etc.;
2. Patients with epilepsy, increased intracranial pressure, tumors, acute cerebral hemorrhage, or other severe neurological diseases, and those with severe functional impairment of organs such as the heart, liver, and kidneys;
3. Head CT/MRI indicates midline shift or significant mass effect, or patients planned for surgical intervention;
4. Head CT/MRI suggests acute cerebral infarction in both sides;
5. Patients who are pregnant or breastfeeding;
6. Patients with severe mental disorders or dementia who cannot cooperate with follow-up;
7. Patients with other severe diseases resulting in an expected survival of less than 90 days;
8. Patients who are participating in other interventional clinical studies within 30 days before the start of this study or after the onset of this condition;
9. Patients who cannot cooperate with informed consent.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active-cTBS group; Patients assigned to the Active-cTBS group will be treated with cTBS and usual medical treatment after endovascular treatment	Device: Transcranial Magnetic Stimulation Active; The patients will be treated with cTBS and usual medical treatment after endovascular treatment
Sham Comparator: Sham-cTBS group; Patients assigned to the Sham-cTBS group will be treated with sham-cTBS and usual medical treatment after endovascular treatment	Device: Transcranial Magnetic Stimulation Sham; The patients will be treated with sham-cTBS and usual medical treatment after endovascular treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes of infarct volumes from baseline to Day 5	5 days after enrollment
Death	The first 5 days after enrollment
NIHSS at Day 5	5 days after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early neurological deterioration	proportion of patients with an increase of ≥4 points in NIHSS at 3 days	3 days after enrollment
Final infarct volume	The infarct volume on DWI at 5 days	5 days after enrollment
Intracranial hemorrhage incidence		24h after enrollment
Proportion of patients with symptomatic intracranial hemorrhage		90 days after enrollment
Proportion of patients with mRS 0-2		90 days after enrollment
Barthel Index score		90 days after enrollment
Stroke recurrence		90 days after enrollment

Collaborators and Investigators

• Sponsor: Xijing Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: October 10, 2024
• First Submitted That Met QC Criteria: October 10, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: August 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; Stroke; Ischemic Stroke
• Other Study ID Numbers: KY20242288-C-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No