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Influence of G-CSF and EPO on Associative Learning and Motor Skills

Primary Purpose

Chronic Stroke, Amyotrophic Lateral Sclerosis

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
granulocyte - colony stimulating factor (G-CSF)
erythropoetin (EPO)
Sponsored by
University Hospital Muenster
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of chronic stroke or amyotrophic lateral sclerosis Exclusion Criteria: leucocytes > 10000/µl hematocrit > 48% thrombocytes < 150000/µl severe rheumatoid arthritis severe infection severe liver or renal failure severe arterial hypertension recurrent thromboembolic events severe coronary heart disease myocardial infarction malignant tumor leukemia peripheral arterial occlusion disease

Sites / Locations

  • Department of neurology, University Hospital of Muenster

Outcomes

Primary Outcome Measures

Learning success in a word learning model
Response time in motor function tests

Secondary Outcome Measures

Response time in a word learning model
Total time and number of keystrokes in motor function tests

Full Information

First Posted
March 1, 2006
Last Updated
April 22, 2009
Sponsor
University Hospital Muenster
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1. Study Identification

Unique Protocol Identification Number
NCT00298597
Brief Title
Influence of G-CSF and EPO on Associative Learning and Motor Skills
Official Title
Influence of G-CSF and EPO on Associative Learning and Motor Skills
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital Muenster

4. Oversight

5. Study Description

Brief Summary
In the study we want to prove whether the subcutaneous application of granulocyte-stimulating factor (G-CSF) and erythropoetin (EPO) influence associative learning and/or motor skills of patients, who suffer from chronic stroke or amyotrophic lateral sclerosis. The study hypothesis is that G-CSF and EPO improve associative learning and/or motor skills.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Stroke, Amyotrophic Lateral Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
granulocyte - colony stimulating factor (G-CSF)
Intervention Type
Drug
Intervention Name(s)
erythropoetin (EPO)
Primary Outcome Measure Information:
Title
Learning success in a word learning model
Title
Response time in motor function tests
Secondary Outcome Measure Information:
Title
Response time in a word learning model
Title
Total time and number of keystrokes in motor function tests

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of chronic stroke or amyotrophic lateral sclerosis Exclusion Criteria: leucocytes > 10000/µl hematocrit > 48% thrombocytes < 150000/µl severe rheumatoid arthritis severe infection severe liver or renal failure severe arterial hypertension recurrent thromboembolic events severe coronary heart disease myocardial infarction malignant tumor leukemia peripheral arterial occlusion disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wolf Rüdiger Schäbitz, MD
Organizational Affiliation
Department of Neurology, University Hospital of Muenster, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of neurology, University Hospital of Muenster
City
Muenster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
D-48149
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
15236398
Citation
Knecht S, Breitenstein C, Bushuven S, Wailke S, Kamping S, Floel A, Zwitserlood P, Ringelstein EB. Levodopa: faster and better word learning in normal humans. Ann Neurol. 2004 Jul;56(1):20-6. doi: 10.1002/ana.20125.
Results Reference
background
PubMed Identifier
16258290
Citation
Schneider A, Kuhn HG, Schabitz WR. A role for G-CSF (granulocyte-colony stimulating factor) in the central nervous system. Cell Cycle. 2005 Dec;4(12):1753-7. doi: 10.4161/cc.4.12.2213. Epub 2005 Dec 27.
Results Reference
background
PubMed Identifier
16007267
Citation
Schneider A, Kruger C, Steigleder T, Weber D, Pitzer C, Laage R, Aronowski J, Maurer MH, Gassler N, Mier W, Hasselblatt M, Kollmar R, Schwab S, Sommer C, Bach A, Kuhn HG, Schabitz WR. The hematopoietic factor G-CSF is a neuronal ligand that counteracts programmed cell death and drives neurogenesis. J Clin Invest. 2005 Aug;115(8):2083-98. doi: 10.1172/JCI23559. Epub 2005 Jul 7.
Results Reference
background
PubMed Identifier
21625426
Citation
Floel A, Warnecke T, Duning T, Lating Y, Uhlenbrock J, Schneider A, Vogt G, Laage R, Koch W, Knecht S, Schabitz WR. Granulocyte-colony stimulating factor (G-CSF) in stroke patients with concomitant vascular disease--a randomized controlled trial. PLoS One. 2011;6(5):e19767. doi: 10.1371/journal.pone.0019767. Epub 2011 May 23.
Results Reference
derived
PubMed Identifier
21423758
Citation
Duning T, Schiffbauer H, Warnecke T, Mohammadi S, Floel A, Kolpatzik K, Kugel H, Schneider A, Knecht S, Deppe M, Schabitz WR. G-CSF prevents the progression of structural disintegration of white matter tracts in amyotrophic lateral sclerosis: a pilot trial. PLoS One. 2011 Mar 14;6(3):e17770. doi: 10.1371/journal.pone.0017770.
Results Reference
derived

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Influence of G-CSF and EPO on Associative Learning and Motor Skills

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