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The purpose of this study was to determine the effect of stroke on post-stroke level of consciousness through a double-blind, placebo-controlled, randomized study design. And Brain 18F-FDG PET was used to reveal the mechanism of recovery after cerebrolysin administration.
Thirty patients with chronic stroke patients with minimal consciousness (MCS) or vegetative human (VS) level of consciousness disorder in the revised coma recovery scale were enrolled. Thirty patients were randomly divided into a Cerebrolysin group and a placebo group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cerebrolysin | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cerebrolysin | Drug | Cerebrolysin 20ml + physiological saline 80ml, 8-35 days, once/day, intravenous administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| CRS-R (JFK Coma recovery scale-revised) | It is a test that analyzes a total of six functions of hearing, vision, movement, speech, communication, and arousal by item to determine the improvement in the level of consciousness of patients with decreased consciousness. These items are scored to determine whether they are in a minimally conscious state (MCS). | up to 11 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Deog Young Kim | Contact | 82-2-2228-3714 | KIMDY@yuhs.ac |
| Name | Affiliation | Role |
|---|---|---|
| Deog Young Kim | Department and Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine, Seoul, Yonsei University College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei University Health System, Severance Hospital | Recruiting | Seoul | South Korea |
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| Placebo | Drug | physiological saline 100ml, 8-35 days, once/day, intravenous administration |
|
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C006952 | cerebrolysin |
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