Potentiation of Procedural Motor Learning in Health and Disease

• ClinicalTrials.gov Identifier: NCT00126087
• Recruitment Status: Terminated
• First Posted: August 2, 2005
• Last Update Posted: January 21, 2013
• Sponsor: University Hospital Muenster
• Information provided by (Responsible Party): University Hospital Muenster

Tracking Information

• First Submitted Date: July 31, 2005
• First Posted Date: August 2, 2005
• Last Update Posted Date: January 21, 2013
• Study Start Date: July 2005
• Actual Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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 (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.
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Potentiation of Procedural Motor Learning in Health and Disease
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Stroke
• Intervention: Drug: dopamine
• Study Arms: Not Provided

Publications *

• Flöel 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.
• Rösser N, Heuschmann P, Wersching H, Breitenstein C, Knecht S, Flöel A. Levodopa improves procedural motor learning in chronic stroke patients. Arch Phys Med Rehabil. 2008 Sep;89(9):1633-41. doi: 10.1016/j.apmr.2008.02.030.

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: January 18, 2013): 18
• Original Enrollment (submitted: July 31, 2005): 40
• Actual Study Completion Date: January 2013
• Actual Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT00126087
• Other Study ID Numbers: Motor-Neuromod_01
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: University Hospital Muenster
• Original Responsible Party: Not Provided
• Current Study Sponsor: University Hospital Muenster
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: University Hospital Muenster
• Verification Date: January 2013