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

Yonsei University

Status and phase

Unknown

Phase 4

Conditions

Stroke

Treatments

Drug: Cerebrolysin

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT04913831

4-2021-0085

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

19 to 90 years old

Volunteers

No Healthy Volunteers

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