Potentiation of Procedural Motor Learning in Health and Disease

NCT00126087 | Terminated Phase 4

• 1 other identifier: Motor-Neuromod_01
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

dopamine; NMDA receptor; brain imaging; neuroplasticity; learning; transcranial direct current stimulation; rehabilitation; aging

Outcome Measures

Primary Outcomes (1)

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

Interventions

dopamine DRUG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Healthy Volunteers and Stroke Patients:
• No antipsychotic, antidepressant drugs, and drugs affecting the dopaminergic system.

Sponsors & Collaborators

• University Hospital Muenster: lead

Study Sites (1)

University of Münster, Department of Neurology

Münster, North Rhine-Westphalia, 48129, Germany

Location

Related Publications (2)

• 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. doi: 10.1002/ana.20536.

  PMID: 15984008 BACKGROUND

• Rosser N, Heuschmann P, Wersching H, Breitenstein C, Knecht S, Floel 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.

  PMID: 18760148 RESULT

MeSH Terms

Conditions

Stroke

Interventions

Dopamine

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biogenic Monoamines; Biogenic Amines; Amines; Organic Chemicals; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Agnes Flöel, MD

  University of Münster, Department of Neurology, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2005
• First Posted: August 2, 2005
• Study Start: July 1, 2005
• Primary Completion: December 1, 2007
• Study Completion: January 1, 2013
• Last Updated: January 21, 2013

Record last verified: 2013-01

Locations

DE (1)