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

Not Applicable

Not yet recruiting

• Conditions: Ischemic Stroke, Acute; Endovascular Thrombectomy

• Registration Number: NCT06639360
• Lead Sponsor: Xijing Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-10-10
• Study First Submitted QC: 2024-10-10
• Last Update Submitted: 2024-10-10
• Study First Posted: 2024-10-14
• Last Update Posted: 2024-10-14
• Study Start: 2024-10-15
• Primary Completion: 2025-09-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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 segment of the middle cerebral artery.

3. DWI shows an infarct volume less than one-third of the MCA territory, with onset of symptoms ≤6 hours, or a head CT within 24 hours of onset indicating an ASPECT score ≥6.

4. Symptom onset time is ≤6 hours or between 6-24 hours with multimodal imaging (assessment) confirming eligibility for thrombectomy.

5. Pre-stroke mRS score is ≤1.

6. NIHSS score before thrombectomy is between 6 and 25.

7. With vascular recanalization of mTICI > 2b/3.

8. 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 with a history of congenital or acquired bleeding disorders, coagulation factor deficiencies, or thrombocytopenia;

6. Patients with blood pressure more than 180/110 mmHg after antihypertensive treatment;

7. Patients who are pregnant or breastfeeding;

8. Patients with severe mental disorders or dementia who cannot cooperate with follow-up;

9. Patients with other severe diseases resulting in an expected survival of less than 90 days; 7. 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; 8. Patients who cannot cooperate with informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes of infarct volumes from baseline to Day 5	5 days after enrollment