Potentiation of Procedural Motor Learning in Health and Disease

January 18, 2013 updated by: University Hospital Muenster

Potentiation of Procedural Motor Learning by Pharmacological Neuromodulation and Transcranial Direct Current Stimulation in Health and Disease

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

18

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Nordrhein-Westfalen
      • Münster, Nordrhein-Westfalen, Germany, 48129
        • University of Münster, Department of Neurology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Muenster

Investigators

  • Principal Investigator: Agnes Flöel, MD, University of Münster, Department of Neurology, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (ACTUAL)

December 1, 2007

Study Completion (ACTUAL)

January 1, 2013

Study Registration Dates

First Submitted

July 31, 2005

First Submitted That Met QC Criteria

July 31, 2005

First Posted (ESTIMATE)

August 2, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

January 21, 2013

Last Update Submitted That Met QC Criteria

January 18, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Motor-Neuromod_01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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