Status:
UNKNOWN
Effects of Cerebrolysin on Level of Consciousness and Brain Metabolism in Disorder of Consciousness After Stroke: Single Center Randomized Controlled Study
Lead Sponsor:
Yonsei University
Conditions:
Stroke
Eligibility:
All Genders
19-90 years
Phase:
PHASE4
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 use...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04913831
Start Date
June 1 2021
End Date
March 1 2024
Last Update
June 4 2021
Active Locations (1)
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1
Yonsei University Health System, Severance Hospital
Seoul, South Korea