Clinical trial NCT00298597: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Stroke
Amyotrophic Lateral Sclerosis
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
First posted: 2006-03-02
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Learning success in a word learning model
measure: Response time in motor function tests
Secondary outcomes:
measure: Response time in a word learning model
measure: Total time and number of keystrokes in motor function tests
Other outcomes:
Locations:
city: Muenster
country: Germany
facility: Department of neurology, University Hospital of Muenster
state: Nordrhein-Westfalen
Study officials:
affiliation: Department of Neurology, University Hospital of Muenster, Germany
name: Wolf Rüdiger Schäbitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.