Effects of Cerebrolysin on Level of Consciousness and Brain Metabolism in Disorder of Consciousness After Stroke: Single Center Randomized Controlled Study

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Cerebrolysin on Level of Consciousness and Brain Metabolism in Disorder of Consciousness After Stroke: Single Center Randomized Controlled Study

Conditions
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Stroke

Intervention / Treatment
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* Drug: Cerebrolysin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cerebrolysin<br> | Drug: Cerebrolysin<br>* Cerebrolysin 20ml + physiological saline 80ml, 8-35 days, once/day, intravenous administration<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* physiological saline 100ml, 8-35 days, once/day, intravenous administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |