NCT04913831

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 19 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Stroke

Interventions

Type	Name	Description
DRUG	Cerebrolysin	Cerebrolysin 20ml + physiological saline 80ml, 8-35 days, once/day, intravenous administration
DRUG	Placebo	physiological saline 100ml, 8-35 days, once/day, intravenous administration

Timeline

• Start date: 2021-06-01
• Primary completion: 2024-03-01
• Completion: 2024-03-01
• First posted: 2021-06-04
• Last updated: 2021-06-04

Locations

1 site across 1 country: South Korea