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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active-cTBS group | Experimental | Patients assigned to the Active-cTBS group will be treated with cTBS and usual medical treatment after endovascular treatment |
|
| Sham-cTBS group | Sham Comparator | Patients assigned to the Sham-cTBS group will be treated with sham-cTBS and usual medical treatment after endovascular treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Magnetic Stimulation Active | Device | The patients will be treated with cTBS and usual medical treatment after endovascular treatment |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Early neurological deterioration | proportion of patients with an increase of ≥4 points in NIHSS at 3 days | 3 days after enrollment |
| Final infarct volume | The infarct volume on DWI at 5 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jingjing Zhao, Dr. | Contact | +86-29-84775365 | zhaojing0110@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hospital | Recruiting | Xi'an | Shaanxi | 710032 | China |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Transcranial Magnetic Stimulation Sham | Device | The patients will be treated with sham-cTBS and usual medical treatment after endovascular treatment |
|
| 5 days after enrollment |
| Intracranial hemorrhage incidence | 24h after enrollment |
| Proportion of patients with symptomatic intracranial hemorrhage | 90 days after enrollment |
| Proportion of patients with mRS 0-2 | 90 days after enrollment |
| Barthel Index score | 90 days after enrollment |
| Stroke recurrence | 90 days after enrollment |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |