NCT06639360RecruitingNot Applicable
Effects of Transcranial Magnetic Stimulation After Endovascular Treatment for Acute Ischemic Stroke
Xijing Hospital1 site in 1 country60 target enrollmentStarted: August 2, 2025Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- NIHSS at Day 5
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Investigators
Study Sites (1)
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