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

Primary Purpose

Stroke

Status
Recruiting
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Cerebrolysin
Placebo
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

19 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Yonsei University Health System, Severance HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cerebrolysin

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
May 25, 2021
Last Updated
May 26, 2021
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT04913831
Brief Title
Effects of Cerebrolysin on Level of Consciousness and Brain Metabolism in Disorder of Consciousness After Stroke: Single Center Randomized Controlled Study
Official Title
Effects of Cerebrolysin on Level of Consciousness and Brain Metabolism in Disorder of Consciousness After Stroke: Single Center Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Recruiting
Study Start Date
June 2021 (Anticipated)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cerebrolysin
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Cerebrolysin
Intervention Description
Cerebrolysin 20ml + physiological saline 80ml, 8-35 days, once/day, intravenous administration
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
physiological saline 100ml, 8-35 days, once/day, intravenous administration
Primary Outcome Measure Information:
Title
CRS-R (JFK Coma recovery scale-revised)
Description
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).
Time Frame
up to 11 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Deog Young Kim
Phone
82-2-2228-3714
Email
KIMDY@yuhs.ac
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deog Young Kim
Organizational Affiliation
Department and Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine, Seoul, Yonsei University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yonsei University Health System, Severance Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deog Young Kim
Phone
82-2-2228-3714
Email
KIMDY@yuhs.ac

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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