Effects of Cerebrolysin on Level of Consciousness and Brain Metabolism in Disorder of Consciousness After Stroke: Single Center Randomized Controlled Study
NCT ID: NCT04913831
Last Updated: 2021-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
30 participants
INTERVENTIONAL
2021-06-30
2024-03-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Cerebrolysin
Cerebrolysin
Cerebrolysin 20ml + physiological saline 80ml, 8-35 days, once/day, intravenous administration
Placebo
Placebo
physiological saline 100ml, 8-35 days, once/day, intravenous administration
Interventions
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Cerebrolysin
Cerebrolysin 20ml + physiological saline 80ml, 8-35 days, once/day, intravenous administration
Placebo
physiological saline 100ml, 8-35 days, once/day, intravenous administration
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
19 Years
90 Years
ALL
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Principal Investigators
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Deog Young Kim
Role: PRINCIPAL_INVESTIGATOR
Department and Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine, Seoul, Yonsei University College of Medicine
Locations
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Yonsei University Health System, Severance Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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4-2021-0085
Identifier Type: -
Identifier Source: org_study_id
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