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

NCT06639360 | Recruiting DMC

• 1 other identifier: KY20242288-C-1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ischemic Stroke, Acute; Endovascular Thrombectomy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Early neurological deterioration

  3 days after enrollment

• Final infarct volume

  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

Study Arms (2)

Active-cTBS group

EXPERIMENTAL

Patients assigned to the Active-cTBS group will be treated with cTBS and usual medical treatment after endovascular treatment

Device: Transcranial Magnetic Stimulation Active

Sham-cTBS group

SHAM COMPARATOR

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

Interventions

Transcranial Magnetic Stimulation Active DEVICE

The patients will be treated with cTBS and usual medical treatment after endovascular treatment

Active-cTBS group

Transcranial Magnetic Stimulation Sham DEVICE

The patients will be treated with sham-cTBS and usual medical treatment after endovascular treatment

Sham-cTBS group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with acute anterior circulation ischemic stroke aged between 18 and 80 years old.
• 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.
• A head CT within 24 hours of onset indicates an ASPECT score ≥6, and meets the guideline-recommended criteria for thrombectomy.
• Pre-stroke mRS score is ≤1.
• NIHSS score before thrombectomy is between 6 and 25.
• With vascular recanalization of mTICI \> 2b/3.
• Informed consent form signed.

You may not qualify if:

• Patients with contraindications to TMS treatment, such as those with metallic foreign objects in the head, pacemakers, implantable drug pumps, cochlear implants, etc.;
• 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;
• Head CT/MRI indicates midline shift or significant mass effect, or patients planned for surgical intervention;
• Head CT/MRI suggests acute cerebral infarction in both sides;
• Patients who are pregnant or breastfeeding;
• Patients with severe mental disorders or dementia who cannot cooperate with follow-up;
• Patients with other severe diseases resulting in an expected survival of less than 90 days;
• 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;
• Patients who cannot cooperate with informed consent.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Jingjing Zhao, Dr.

CONTACT

+86-29-84775365; zhaojing0110@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: October 15, 2024
• Study Start: August 2, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)