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Clinical Trials/NCT06639360
NCT06639360
Recruiting
Not Applicable

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

Xijing Hospital1 site in 1 country60 target enrollmentAugust 2, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ischemic Stroke, Acute
Sponsor
Xijing Hospital
Enrollment
60
Locations
1
Primary Endpoint
NIHSS at Day 5
Status
Recruiting
Last Updated
4 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2, 2025
End Date
December 31, 2026
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Xijing Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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 ≤
  • NIHSS score before thrombectomy is between 6 and
  • With vascular recanalization of mTICI \> 2b/
  • Informed consent form signed.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

NIHSS at Day 5

Time Frame: 5 days after enrollment

Changes of infarct volumes from baseline to Day 5

Time Frame: 5 days after enrollment

Death

Time Frame: The first 5 days after enrollment

Secondary Outcomes

  • Intracranial hemorrhage incidence(24h after enrollment)
  • Early neurological deterioration(3 days after enrollment)
  • Final infarct volume(5 days after enrollment)
  • Proportion of patients with mRS 0-2(90 days after enrollment)
  • Proportion of patients with symptomatic intracranial hemorrhage(90 days after enrollment)
  • Barthel Index score(90 days after enrollment)
  • Stroke recurrence(90 days after enrollment)

Study Sites (1)

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