Endovascular Thrombectomy, Ischemic Stroke, Acute
Conditions
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.
Interventions
The patients will be treated with cTBS and usual medical treatment after endovascular treatment
DEVICETranscranial Magnetic Stimulation Sham
The patients will be treated with sham-cTBS and usual medical treatment after endovascular treatment
Sponsors
Xijing Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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/M2 segment of the middle cerebral artery. 3. A head CT within 24 hours of onset indicates an ASPECT score ≥6, and meets the guideline-recommended criteria for thrombectomy. 4. Pre-stroke mRS score is ≤1. 5. NIHSS score before thrombectomy is between 6 and 25. 6. With vascular recanalization of mTICI \> 2b/3. 7. 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 who are pregnant or breastfeeding; 6. Patients with severe mental disorders or dementia who cannot cooperate with follow-up; 7. Patients with other severe diseases resulting in an expected survival of less than 90 days; 8. 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; 9. Patients who cannot cooperate with informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with symptomatic intracranial hemorrhage | 90 days after enrollment | — |
| Proportion of patients with mRS 0-2 | 90 days after enrollment | — |
| Early neurological deterioration | 3 days after enrollment | proportion of patients with an increase of ≥4 points in NIHSS at 3 days |
| Stroke recurrence | 90 days after enrollment | — |
| Barthel Index score | 90 days after enrollment | — |
| Final infarct volume | 5 days after enrollment | The infarct volume on DWI at 5 days |
| Intracranial hemorrhage incidence | 24h after enrollment | — |
Countries
China
Contacts
Primary ContactJingjing Zhao, Dr.
Outcome results
None listed