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

Phase 4

• Conditions: Stroke
• Interventions: Drug: Cerebrolysin; Drug: Placebo

• Registration Number: NCT04913831
• Lead Sponsor: Yonsei University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-05
• Study First Submitted: 2021-05-25
• Study First Submitted QC: 2021-05-26
• Last Update Submitted: 2021-05-26
• Study Start: 2021-06
• Study First Posted: 2021-06-04
• Last Update Posted: 2021-06-04
• Primary Completion: 2024-03
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Ischemic or hemorrhagic stroke patients
• Stroke with CT or MRI diagnosis
• Chronic patients with more than 3 months of stroke onset
• Patients with vegetative status or minimal consciousness (Coma Recovery Scale -revised: CRS-R)
• Age: 19 to 90 years old
• A person who voluntarily consents to the clinical trial in writing by the principal or legal representative

Exclusion Criteria

• In case of contraindications, including allergies to cerebrolysin
• Patients with contraindications to PET
• Progressive or unstable stroke
• In case of accompanying serious neurogenic disease
• Major depressive disorder, schizophrenia, bipolar disorder, dementia, and other serious psychiatric diseases.
• History of alcohol or other drug addiction within 3 years of onset
• In case of accompanying serious liver, kidney, heart, or respiratory disease
• If you have the following medical abnormalities (Total serum bilirubin> 4 mg/dL, alkaline phosphatase> 250 U/L, SGOT/AST> 150 U/L, SGPT/ALT> 150 U/L, or creatinine) > 3.5 mg/dL)
• In case of having a medical disease that is less than 1 year old
• During pregnancy or lactation
• Participating in other therapeutic research

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cerebrolysin	Cerebrolysin	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
CRS-R (JFK Coma recovery scale-revised)	up to 11 weeks	It is a test that analyzes a total of six functions of hearing, vision, movement, speech, communication, and arousal by item to determine the improvement in the level of consciousness of patients with decreased consciousness. These items are scored to determine whether they are in a minimally conscious state (MCS).

Trial Locations

Locations (1)

Yonsei University Health System, Severance Hospital; 🇰🇷 Seoul, Korea, Republic of