Stroke
Conditions
Brief summary
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.
Interventions
DRUGCerebrolysin
Cerebrolysin 20ml + physiological saline 80ml, 8-35 days, once/day, intravenous administration
DRUGPlacebo
physiological saline 100ml, 8-35 days, once/day, intravenous administration
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Ischemic or hemorrhagic stroke patients * Stroke with CT or MRI diagnosis * Chronic patients with more than 3 months of stroke onset * Patients with vegetative status or minimal consciousness (Coma Recovery Scale -revised: CRS-R) * Age: 19 to 90 years old * A person who voluntarily consents to the clinical trial in writing by the principal or legal representative
Exclusion criteria
* In case of contraindications, including allergies to cerebrolysin * Patients with contraindications to PET * Progressive or unstable stroke * In case of accompanying serious neurogenic disease * Major depressive disorder, schizophrenia, bipolar disorder, dementia, and other serious psychiatric diseases. * History of alcohol or other drug addiction within 3 years of onset * In case of accompanying serious liver, kidney, heart, or respiratory disease * If you have the following medical abnormalities (Total serum bilirubin\> 4 mg/dL, alkaline phosphatase\> 250 U/L, SGOT/AST\> 150 U/L, SGPT/ALT\> 150 U/L, or creatinine) \> 3.5 mg/dL) * In case of having a medical disease that is less than 1 year old * During pregnancy or lactation * Participating in other therapeutic research
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CRS-R (JFK Coma recovery scale-revised) | up to 11 weeks | 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). |
Countries
South Korea
Contacts
Primary ContactDeog Young Kim
Outcome results
None listed