Efficacy and Safety of Cerebrolysin on Prolonged Disorders of Consciousness

Launched by KONKUK UNIVERSITY MEDICAL CENTER · Jun 8, 2020

Keywords

ClinConnect Summary

This clinical trial is investigating the effects of a treatment called cerebrolysin on patients who have been in a prolonged state of unconsciousness due to a type of brain injury known as a hemorrhagic stroke. The goal is to see if cerebrolysin can help improve consciousness in these patients. The study will involve giving participants either cerebrolysin mixed with a saline solution or just saline alone for two weeks, starting four days after their stroke.

To be eligible for this trial, patients must be between 19 and 80 years old and have had a hemorrhagic stroke confirmed by imaging tests like CT or MRI. They should have been in a vegetative state or minimally conscious state for more than four weeks. Patients with certain serious health conditions or those taking specific medications that could affect their consciousness will not be able to participate. This study is still in the planning stages and has not begun recruiting participants yet. If you or a loved one is considering this trial, you will be informed about what to expect and the potential risks and benefits of participating.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• • 1. Patients with hemorrhagic stroke confirmed by CT or MRI
• • 2. Patients who have been in disorders of consciousness for more than 4 weeks after the onset of hemorrhagic stroke
• • 3. Patients in a vegetative state or minimally conscious state (Coma Recovery Scale -revised: CRS-R assessment)
• • 4. Age: 19 to 80 years of age
• • 5. Patients who have voluntarily given written informed consent to participate in the study by themselves or their legal representative.
• • Exclusion Criteria
• • 1. Patients with confirmed epileptiform discharges on EEG
• • 2. Patients with brain parenchymal defects
• • 3. Patients with advanced liver, kidney, cardiac, or pulmonary disease.
• • 4. Chronic treatment with medications that may affect consciousness, such as antidepressants, antipsychotic drugs, nootropic drugs, and vasodilators.
• • 5. 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.
• • 6. Alcohol or drug abuse or dependence within the last 2 years (DSM-V criteria).
• • 7. Significant systemic disease or unstable medical condition that may compromise compliance with the study protocol.
• • 8. Administration of a contraindicated drug is essential for medical purposes.
• • 9. Contraindications to the study drug (cerebrolysin).
• • 10. Participation in another therapeutic study