Potentiation of Procedural Motor Learning in Health and Disease

This study has been terminated.
(no further funding available for recruiting and testing participants)
Sponsor:
Information provided by (Responsible Party):
University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT00126087
First received: July 31, 2005
Last updated: January 18, 2013
Last verified: January 2013
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Enrollment: 18
Study Start Date: July 2005
Study Completion Date: January 2013
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00126087

Locations
Germany
University of Münster, Department of Neurology
Münster, Nordrhein-Westfalen, Germany, 48129
Sponsors and Collaborators
University Hospital Muenster
Investigators
Principal Investigator: Agnes Flöel, MD University of Münster, Department of Neurology, Germany
  More Information

Publications:
Responsible Party: University Hospital Muenster
ClinicalTrials.gov Identifier: NCT00126087     History of Changes
Other Study ID Numbers: Motor-Neuromod_01
Study First Received: July 31, 2005
Last Updated: January 18, 2013
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

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

ClinicalTrials.gov processed this record on August 01, 2014