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Clinical Trials/NCT01085968
NCT01085968
Completed
Early Phase 1

PC-based Rehabilitation of Motor Planning Deficits in Parkinson Disease

VA Office of Research and Development0 sites54 target enrollmentJuly 2010

Overview

Phase
Early Phase 1
Intervention
Not specified
Conditions
Parkinson's Disease
Sponsor
VA Office of Research and Development
Enrollment
54
Primary Endpoint
Reaction Time and Variability for Movement Task
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

We are testing a computer game-style rehabilitation program for people with Parkinson's disease (PD). People with PD often have difficulty with motor planning, such as initiating or starting movements. We believe that our program will improve performance on a movement initiation task as well as on activities of daily living, such as walking, preparing a meal or opening a medicine bottle. We will measure brain function using functional MRI before and after training to identify brain areas that are involved in improved performance. If effective, computer based training will be an inexpensive treatment for motor planning deficits in PD that is free from side effects and easy to administer to a large number of patients.

Detailed Description

Our approach is to use PD-based adaptive training to improve performance on IG movement initiation in patients with PD. We have three aims, 1) to systematically evaluate cognitive rehabilitation in people with Parkinson's disease (PD), 2) to examine the neural mechanisms subserving cognitive rehabilitation in PD and 3) to assess the ecological validity of cognitive rehabilitation in PD. We will focus on a single aspect of cognitive function, the decision to initiate a movement. Movements can be internally generated (IG) or externally cued, and motor deficits in PD are typically linked to IG movements. The protocol is designed to drive beneficial neuroplastic changes using a paradigm similar to those that have shown promising results in traumatic brain injury patients. In addition, we will use fMRI to measure activity in underlying basal ganglia-thalamocortical circuits. Finally, because the goal of any research regarding the pathophysiology of disease is to improve the lives of patients with the disease, behavioral and neuropsychological measures will be correlated with fMRI measured functional abnormalities before and after training. Improvement in the initiation of movement has the potential to dramatically improve daily functioning including reducing falls, improving language production and improving proficiency of activities of daily living.

Registry
clinicaltrials.gov
Start Date
July 2010
End Date
August 2015
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Clinical diagnosis of PD dominant on the right side with a Hx of response to dopamine replacement.

Exclusion Criteria

  • Contraindication to MRI
  • History of stroke or significant head trauma
  • Significant vision impairment
  • Hx of brain surgery or claustrophobia
  • Medication change \<4 weeks
  • Atypical PD
  • Severe tremor
  • Presence of motor fluctuations or dyskinesia
  • Significantly impaired limb or joint function
  • Significant memory impairment

Outcomes

Primary Outcomes

Reaction Time and Variability for Movement Task

Time Frame: time of enrollment and 2 months following enrollment (before and after training)

Before and after computer training outcome measures: left, right, bimanual external cue reaction time; left, right, bimanual external cue error; left, right, bimanual internally generated reaction time; left, right, bimanual internally generated error for four-digit trials.

Secondary Outcomes

  • Symbol Digit Modality Test (SDMT)(time of enrollment and 2 months following enrollment (before and after training))
  • Neuropsychological Measures of Cognitive Function, Including Reaction Time and Time to Completion(time of enrollment and 2 months following enrollment (before and after training))
  • Task Errors and Variability(time of enrollment and 2 months following enrollment (before and after training))
  • Functional Dexterity Test (FDT)(time of enrollment and 2 months following enrollment (before and after training))

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