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

Sponsor

Yonsei University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04913831

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Drug: Cerebrolysin Drug: Placebo	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2021

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cerebrolysin	Drug: Cerebrolysin Cerebrolysin 20ml + physiological saline 80ml, 8-35 days, once/day, intravenous administration
Placebo Comparator: Placebo	Drug: Placebo physiological saline 100ml, 8-35 days, once/day, intravenous administration

Arm

Intervention/Treatment

Experimental: Cerebrolysin

Drug: Cerebrolysin

Cerebrolysin 20ml + physiological saline 80ml, 8-35 days, once/day, intravenous administration

Placebo Comparator: Placebo

Drug: Placebo

physiological saline 100ml, 8-35 days, once/day, intravenous administration

Outcome Measures

Primary Outcome Measures

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 90 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yonsei University Health System, Severance Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

Yonsei University

Investigators

Principal Investigator: Deog Young Kim, Department and Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine, Seoul, Yonsei University College of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yonsei University

ClinicalTrials.gov Identifier:

NCT04913831

Other Study ID Numbers:

4-2021-0085

First Posted:

Jun 4, 2021

Last Update Posted:

Jun 4, 2021

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Stroke

Consciousness Disorders

Cerebrolysin

Study Results

No Results Posted as of Jun 4, 2021