Cognitive Rehabilitation in Parkinson's Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Department of Veterans Affairs
Sponsor:
Collaborator:
LSUHSC-S
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01085968
First received: March 10, 2010
Last updated: July 31, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Parkinson's Disease
Behavioral: PC based training
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: PC-based Rehabilitation of Motor Planning Deficits in Parkinson Disease

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 46
Study Start Date: July 2010
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
PD subjects
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
Active Comparator: Arm 2
Age matched controls
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

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.

  Eligibility

Ages Eligible for Study:   55 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  • Depression or daytime sleepiness
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01085968

Contacts
Contact: Elizabeth A Disbrow, PhD (916) 366-5340 edisbr@lsuhsc.edu

Locations
United States, Louisiana
Overton Brooks VA Medical Center, Shreveport, LA Recruiting
Shreveport, Louisiana, United States, 71101
Contact: Elizabeth A Disbrow, PhD    916-366-5340    edisbr@lsuhsc.edu   
Principal Investigator: Elizabeth A Disbrow, PhD         
Sponsors and Collaborators
LSUHSC-S
Investigators
Principal Investigator: Elizabeth A Disbrow, PhD Overton Brooks VA Medical Center, Shreveport, LA
  More Information

Additional Information:
Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01085968     History of Changes
Other Study ID Numbers: E7185-R
Study First Received: March 10, 2010
Last Updated: July 31, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Parkinson's disease
Cognitive deficits
fMRI
neuro rehabilitation
Age Matched Controls

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on September 22, 2014