Cognitive Rehabilitation in Parkinson's Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Department of Veterans Affairs
Sponsor:
Collaborator:
University of California, Davis
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01085968
First received: March 10, 2010
Last updated: February 20, 2014
Last verified: February 2014

March 10, 2010
February 20, 2014
July 2010
February 2014   (final data collection date for primary outcome measure)
Reaction time and variability for movement task [ Time Frame: time of study enrollment, 2 months and 12 months after enrollment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01085968 on ClinicalTrials.gov Archive Site
  • functional MRI measured brain activation [ Time Frame: time of enrollment and 2 months following enrollment (before and after training) ] [ Designated as safety issue: No ]
  • Neuropsychological measures of cognitive function, including reaction time, time to completion and % correct [ Time Frame: time of enrollment and 2 months following enrollment (before and after training) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Cognitive Rehabilitation in Parkinson's Disease
PC-based Rehabilitation of Motor Planning Deficits in Parkinson Disease

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.

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.

Interventional
Phase 0
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Parkinson's Disease
Behavioral: PC based training
Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer.
Other Name: training
  • Experimental: Arm 1
    PD subjects
    Intervention: Behavioral: PC based training
  • Active Comparator: Arm 2
    Age matched controls
    Intervention: Behavioral: PC based training
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
46
September 2014
February 2014   (final data collection date for primary outcome measure)

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
  • Depression or daytime sleepiness
Both
55 Years to 75 Years
Yes
Contact: Elizabeth A Disbrow, PhD (916) 366-5340 edisbr@lsuhsc.edu
United States
 
NCT01085968
E7185-R
No
Department of Veterans Affairs
Department of Veterans Affairs
University of California, Davis
Principal Investigator: Elizabeth A Disbrow, PhD Overton Brooks VA Medical Center, Shreveport, LA
Department of Veterans Affairs
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP