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Potentiation of Procedural Motor Learning in Health and Disease - Article


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Clinical Trial: Potentiation of Procedural Motor Learning in Health and Disease

This study is currently recruiting patients.
Verified by University Hospital Muenster July 2005

Sponsored by: University Hospital Muenster
Information provided by: University Hospital Muenster
ClinicalTrials.gov Identifier: NCT00126087

Purpose

We plan to improve learning of motor skills by pharmacolocical means (dopamine), and by noninvasive brain stimlulation. We will study both healthy subjects and chronic stroke patients. In addition, we want to study the mechanisms of enhanced learning, on the molecular and the systems level.
Condition Intervention Phase
Stroke
Aging
 Drug: dopamine
Phase IV

MedlinePlus related topics:  Stroke

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

Further Study Details: 
Primary Outcomes: Procedural motor learning (decrease in reaction time in ms)after the respective intervention (dopamine, transcranial direct current stimulation), compared to placebo.
Expected Total Enrollment:  40

Study start: July 2005;  Expected completion: June 2009
Last follow-up: June 2008;  Data entry closure: December 2008

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. My 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: (a) expand these exciting findings to procedural motor learning; (b) explore the interaction with age, brain lesions, add-on interventions such as transcranial direct current stimulation (tDCS); and (c) 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 I plan to delineate the underlying mechanisms of this effect by exploring 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   -   80 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

  • 1) Healthy volunteers. normal neurological examination. Mini-Mental-State Examination of > 27 . Right handedness

2) Stroke patients: Cortical or subcortical stroke with an initial severe hemiparesis MRC scale < 2 that has recovered to a degree that they 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:

  • 1) Healthy volunteers: No antipsychotic, antidepressant drugs, and drugs affecting the dopaminergic system.

2) Stroke patients: No antipsychotic, antidepressant drugs, and drugs affecting the dopaminergic system.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00126087

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

Germany, Nordrhein-Westfalen
      University of Münster, Department of Neurology, MÜNSTER,  Nordrhein-Westfalen,  48129,  Germany; Recruiting
Kreuznacht  +49-251-83-55967    kreuznac@klinikum.uni-muenster.de 
Agnes Flöel, MD,  Principal Investigator

Study chairs or principal investigators

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

More Information

Publications

Floel A, Breitenstein C, Hummel F, Celnik P, Gingert C, Sawaki L, Knecht S, Cohen LG. Dopaminergic influences on formation of a motor memory. Ann Neurol. 2005 Jul;58(1):121-30.

Study ID Numbers:  Motor-Neuromod_01
Last Updated:  August 1, 2005
Record first received:  August 1, 2005
ClinicalTrials.gov Identifier:  NCT00126087
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices
ClinicalTrials.gov processed this record on 2005-08-02

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