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Potentiation of Procedural Motor Learning in Health and Disease
This study is currently recruiting participants.
Verified by University Hospital Muenster, April 2007
First Received: July 31, 2005   Last Updated: April 19, 2007   History of Changes
Sponsored by: University Hospital Muenster
Information provided by: University Hospital Muenster
ClinicalTrials.gov Identifier: NCT00126087
  Purpose

The investigators plan to improve the learning of motor skills by pharmacological means (dopamine), and by noninvasive brain stimulation. They will study both healthy subjects and chronic stroke patients. In addition, they want to study the mechanisms of enhanced learning, on the molecular and the systems level.


Condition Intervention Phase
Stroke
Drug: dopamine
Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Official Title: Potentiation of Procedural Motor Learning by Pharmacological Neuromodulation and Transcranial Direct Current Stimulation in Health and Disease

Resource links provided by NLM:


Further study details as provided by University Hospital Muenster:

Primary Outcome Measures:
  • Procedural motor learning (decrease in reaction time in ms) after the respective intervention (dopamine, transcranial direct current stimulation), compared to placebo

Estimated Enrollment: 40
Study Start Date: July 2005
Estimated Study Completion Date: June 2008
Detailed Description:

Adaptive behavior requires procedural motor learning, i.e. the acquisition of motor skills. Procedural learning is particularly critical in the rehabilitation of chronic motor deficits after stroke. A potent modulator of motor function and learning is found in the endogenous dopaminergic system. The investigator's own work could demonstrate that formation of an elementary motor memory, which constitutes the first step in acquiring more complex motor skills, can be enhanced in both healthy subjects and chronic stroke patients by pre-medication with levodopa. The aim of the present proposal is to:

  • expand these exciting findings to procedural motor learning;
  • explore the interaction with age, brain lesions, add-on interventions such as transcranial direct current stimulation (tDCS); and
  • illuminate the underlying mechanisms.

The effect of levodopa +/- tDCS on procedural motor learning and cortical excitability will be studied in healthy volunteers and stroke patients. Then the investigator plans to delineate the underlying mechanisms of this effect by exploring N-methyl-D-asparate (NMDA) receptor-dependency of levodopa-enhanced learning and changes in activation and connectivity (using functional magnetic resonance imaging) in the respective neural networks resulting from the interaction of learning and dopaminergic neuromodulation.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Healthy Volunteers:

  • Normal neurological examination
  • Mini Mental State Examination of > 27
  • Right handedness

Stroke Patients:

  • Cortical or subcortical stroke with an initial severe hemiparesis Medical Research Council (MRC) scale < 2 that has recovered to a degree that patients are able to perform the proposed task (in general > MRC 4.5, with low spasticity, work in progress on motor learning in stroke patients)
  • At least 1 year post-stroke
  • Mini Mental State Examination of > 27
  • Right-handedness

Exclusion Criteria:

Healthy Volunteers and Stroke Patients:

  • No antipsychotic, antidepressant drugs, and drugs affecting the dopaminergic system.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00126087

Contacts
Contact: Agnes Flöel, MD +49 251 83 ext 49970 floeel@uni-muenster.de
Contact: Caterina Breitenstein, PhD +49 251 83 ext 49969 breitens@uni-muenster.de

Locations
Germany, Nordrhein-Westfalen
University of Münster, Department of Neurology Recruiting
Münster, Nordrhein-Westfalen, Germany, 48129
Contact: Kreuznacht     +49-251-83-55967     kreuznac@klinikum.uni-muenster.de    
Principal Investigator: Agnes Flöel, MD            
Sponsors and Collaborators
University Hospital Muenster
Investigators
Principal Investigator: Agnes Flöel, MD University of Münster, Department of Neurology, Germany
  More Information

Publications:
Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
Study ID Numbers: Motor-Neuromod_01
Study First Received: July 31, 2005
Last Updated: April 19, 2007
ClinicalTrials.gov Identifier: NCT00126087     History of Changes
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Muenster:
dopamine
NMDA receptor
brain imaging
neuroplasticity
learning
transcranial direct current stimulation
rehabilitation
aging

Study placed in the following topic categories:
Neurotransmitter Agents
Dopamine
Cerebral Infarction
Stroke
Dopamine Agents
Peripheral Nervous System Agents
Cardiovascular Agents

Additional relevant MeSH terms:
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cardiotonic Agents
Sympathomimetics
Physiological Effects of Drugs
Cardiovascular Agents
Protective Agents
Pharmacologic Actions
Dopamine
Autonomic Agents
Therapeutic Uses
Dopamine Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 10, 2009