Efficacy and Safety of Cerebrolysin on Prolonged Disorders of Consciousness (NCT04427241) | Clinical Trial Compass
UnknownPhase 4
Efficacy and Safety of Cerebrolysin on Prolonged Disorders of Consciousness
South Korea12 participantsStarted 2023-06-01
Plain-language summary
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
Who can participate
Age range19 Years – 120 Years
SexALL
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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).