Efficacy and Safety of Cerebrolysin on Prolonged Disorders of Consciousness

Study Overview
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Brief Summary
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Object: To determine the effect of cerebrolysin on prolonged disorders of consciousness caused by hemorrhagic stroke. Participants: patients with prolonged disorders of consciousness due to severe traumatic brain injury Intervention: 30 ml cerebrolysin + 70 ml normal saline, days 4-17, once/day, intravenously or 100 ml normal saline, days 4-17, once/day, IV Comparison: cerebrolysin group versus control group Outcome: Coma Recovery Scale-revised, FDG-PET signal

Official Title
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Efficacy and Safety of Cerebrolysin on Prolonged Disorders of Consciousness in Patients With Hemorrhagic Stroke: A Pilot Study

Conditions
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Disorder of Consciousness, Hemorrhagic Stroke

Intervention / Treatment
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* Drug: Cerebrolysin
* Drug: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Patients with hemorrhagic stroke confirmed by CT or MRI Patients who have been in disorders of consciousness for more than 4 weeks after the onset of hemorrhagic stroke Patients in a vegetative state or minimally conscious state (Coma Recovery Scale -revised: CRS-R assessment) Age: 19 to 80 years of age Patients who have voluntarily given written informed consent to participate in the study by themselves or their legal representative. Exclusion Criteria Patients with confirmed epileptiform discharges on EEG Patients with brain parenchymal defects Patients with advanced liver, kidney, cardiac, or pulmonary disease. Chronic treatment with medications that may affect consciousness, such as antidepressants, antipsychotic drugs, nootropic drugs, and vasodilators. History of serious illness within the last two years (cancer, hematologic, renal, hepatic, or coronary artery disease, psychiatric illness, diabetes, myocardial infarction, epilepsy), no evidence of secondary damage to major organs, and well-controlled diabetes or hypertension. Alcohol or drug abuse or dependence within the last 2 years (DSM-V criteria). Significant systemic disease or unstable medical condition that may compromise compliance with the study protocol. Administration of a contraindicated drug is essential for medical purposes. Contraindications to the study drug (cerebrolysin). Participation in another therapeutic study

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 120 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>30 ml cerebrolysin + 70 ml normal saline, days 4-17, once/day, intravenously | Drug: Cerebrolysin<br>* 30 ml cerebrolysin + 70 ml normal saline, days 4-17, once/day, intravenously<br>|
| Placebo Comparator: Control<br>100 ml normal saline, days 4-17, once/day, IV | Drug: Control<br>* 100 ml normal saline, days 4-17, once/day, IV<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coma Recovery Scale - revised | Assessing the degree of disorders of consciousness | 2 days after randomization | 
| Coma Recovery Scale - revised | Assessing the degree of disorders of consciousness | 17 days after randomization | 
| Positron Emitting Tomography | Assessing the degree of brain neural network activity | 2 days after randomization | 
| Positron Emitting Tomography | Assessing the degree of brain neural network activity | 17 days after randomization |