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Potentiation of Procedural Motor Learning in Health and Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00126087
Recruitment Status : Terminated (no further funding available for recruiting and testing participants)
First Posted : August 2, 2005
Last Update Posted : January 21, 2013
Sponsor:
Information provided by (Responsible Party):
University Hospital Muenster

Tracking Information
First Submitted Date  ICMJE July 31, 2005
First Posted Date  ICMJE August 2, 2005
Last Update Posted Date January 21, 2013
Study Start Date  ICMJE July 2005
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 18, 2005)
Procedural motor learning (decrease in reaction time in ms) after the respective intervention (dopamine, transcranial direct current stimulation), compared to placebo
Original Primary Outcome Measures  ICMJE
 (submitted: July 31, 2005)
Procedural motor learning (decrease in reaction time in ms)after the respective intervention (dopamine, transcranial direct current stimulation), compared to placebo.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Potentiation of Procedural Motor Learning in Health and Disease
Official Title  ICMJE Potentiation of Procedural Motor Learning by Pharmacological Neuromodulation and Transcranial Direct Current Stimulation in Health and Disease
Brief Summary 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Stroke
Intervention  ICMJE Drug: dopamine
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 18, 2013)
18
Original Enrollment  ICMJE
 (submitted: July 31, 2005)
40
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00126087
Other Study ID Numbers  ICMJE Motor-Neuromod_01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University Hospital Muenster
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE University Hospital Muenster
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Agnes Flöel, MD University of Münster, Department of Neurology, Germany
PRS Account University Hospital Muenster
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP