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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04913831
• Other study ID #: 4-2021-0085
• Status: Recruiting
• Phase: Phase 4
• Start date: June 2021
• Est. completion date: March 2024

Study information

• Verified date: May 2021
• Source: Yonsei University
• Contact: Deog Young Kim
• Phone: 82-2-2228-3714
• Email: KIMDY[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Consciousness Disorders
• Stroke

Intervention

Drug:
• Cerebrolysin
Cerebrolysin 20ml + physiological saline 80ml, 8-35 days, once/day, intravenous administration
• Placebo
physiological saline 100ml, 8-35 days, once/day, intravenous administration

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University Health System, Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CRS-R (JFK Coma recovery scale-revised)	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).	up to 11 weeks