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Recruiting NCT06639360

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

No phase Interventional Ischemic Stroke, Acute Endovascular Thrombectomy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transcranial Magnetic Stimulation Active, Transcranial Magnetic Stimulation Sham.
Who it may be relevant to
Registry conditions: Ischemic Stroke, Acute, Endovascular Thrombectomy. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device Transcranial Magnetic Stimulation Active
    The patients will be treated with 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

Primary outcome measures

  • Changes of infarct volumes from baseline to Day 5 [Time frame: 5 days after enrollment]
  • Death [Time frame: The first 5 days after enrollment]
  • NIHSS at Day 5 [Time frame: 5 days after enrollment]
Secondary outcome measures (7)
  • Early neurological deterioration [Time frame: 3 days after enrollment]
  • Final infarct volume [Time frame: 5 days after enrollment]
  • Intracranial hemorrhage incidence [Time frame: 24h after enrollment]
  • Proportion of patients with symptomatic intracranial hemorrhage [Time frame: 90 days after enrollment]
  • Proportion of patients with mRS 0-2 [Time frame: 90 days after enrollment]
  • Barthel Index score [Time frame: 90 days after enrollment]
  • Stroke recurrence [Time frame: 90 days after enrollment]

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 ≤1.
  • NIHSS score before thrombectomy is between 6 and 25.
  • With vascular recanalization of mTICI > 2b/3.
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Xijing Hospital — Xi'an

Identifiers

NCT: NCT06639360 · KY20242288-C-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗