Cerebrolysin for prolonged disorders of consciousness after hemorrhagic stroke

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

This study will test whether daily Cerebrolysin infusions can help adults who have been in a vegetative or minimally conscious state for more than four weeks after a hemorrhagic stroke.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 19 Years to 120 Years
• Sex: All
• Sponsor: Konkuk University Medical Center (other)
• Locations: 1 site (Seoul)
• Trial ID: NCT04427241 on ClinicalTrials.gov

What this trial studies

This interventional Phase 4 protocol compares daily intravenous Cerebrolysin (30 mL Cerebrolysin mixed with 70 mL saline) to a control infusion of 100 mL saline, administered once daily from days 4–17 after stroke onset. Eligible participants are adults aged 19–80 who have been in a vegetative state or minimally conscious state for more than four weeks after a hemorrhagic stroke and meet EEG and comorbidity criteria. Primary outcomes include recovery of consciousness measured by the Coma Recovery Scale–Revised and changes in brain metabolism on FDG-PET, with assessments during and after the treatment period. Treatments and follow-up are conducted at a single center (Konkuk University Medical Center) with participants assigned to either the Cerebrolysin arm or the control arm.

Who should consider this trial

Good fit: Adults aged 19–80 with CT- or MRI-confirmed hemorrhagic stroke who have been in a vegetative or minimally conscious state for more than four weeks and whose patient or legal representative can provide written informed consent are ideal candidates.

Not a fit: Patients with epileptiform discharges on EEG, large brain parenchymal defects, advanced liver/kidney/heart/lung disease, chronic medications that alter consciousness, recent serious illnesses, or outside the 19–80 age range are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If effective, Cerebrolysin could speed or improve recovery of consciousness and functional outcomes for people with prolonged disorders of consciousness after hemorrhagic stroke.

How similar studies have performed: Prior trials and case series of Cerebrolysin in stroke and traumatic brain injury have shown mixed results, and evidence specifically for prolonged disorders of consciousness is limited.

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

Where this trial is running

Seoul

• Konkuk University Medical Center Research Coordinating Center — Seoul, South Korea (RECRUITING)

Study contacts

• Study coordinator: Jongmin Lee, M.D., Ph.D.

Conditions: Disorder of Consciousness, Hemorrhagic Stroke