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Cognitive Rehabilitation in Parkinson's Disease

This study has been completed.
Sponsor:
Collaborator:
Louisiana State University Health Sciences Center Shreveport
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01085968
First received: March 10, 2010
Last updated: August 16, 2016
Last verified: August 2016
  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 VA Office of Research and Development:

Primary Outcome Measures:
  • Reaction Time and Variability for Movement Task [ Time Frame: time of enrollment and 2 months following enrollment (before and after training) ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Neuropsychological Measures of Cognitive Function, Including Reaction Time and Time to Completion [ Time Frame: time of enrollment and 2 months following enrollment (before and after training) ] [ Designated as safety issue: No ]

    Modified Emory Functional Ambulatory Profile (mEFAP); mobility test Task 1: 5 meter walk on hard surface; timed. Task 2: 5 meter walk on carpeted surface, timed. Task 3: Timed up and go; rise from chair, walk 3 meters, walk back, sit down in chair, timed.

    Task 4: Obstacle course, similar to the Timed up and go, with 2 obstacles to be stepped over while walking forward and coming back; timed.

    Task 5: Ascend and descend 5 steps of stairs; timed.


  • Task Errors and Variability [ Time Frame: time of enrollment and 2 months following enrollment (before and after training) ] [ Designated as safety issue: No ]
    Left, right and bimanual errors in external cue and internally generated tasks for four-digit trials

  • Functional Dexterity Test (FDT) [ Time Frame: time of enrollment and 2 months following enrollment (before and after training) ] [ Designated as safety issue: No ]

    Functional Dexterity test (FDT): a motor dexterity measurement for hands. Task: Pick up and flip wooden pegs on a 4x4 pegboard in a zig-zag pattern; timed. Task is performed 2 times per hand Modified Task: Interchange 2 columns of of pegs (4 pegs each side) simultaneously. No flipping is required.

    5 second penalty to time score for 1.) using the pegboard to help with flipping and 2.) supinating of the hand; per occurrence. 10 second penalty to time score for dropping a peg, per occurrence.


  • Symbol Digit Modality Test (SDMT) [ Time Frame: time of enrollment and 2 months following enrollment (before and after training) ] [ Designated as safety issue: No ]

    Symbol Digit Modality Test (SDMT): Participants are given a key of numbers (1-9) corresponding to symbols for reference.

    Task: Participants are given a page of symbols and are instructed to say aloud the number corresponding to each symbol on the page.

    This task is timed for completion and the score is reported as the number of symbol to number matching correct in 90 seconds.



Enrollment: 54
Study Start Date: July 2010
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PD Subjects
PD subjects who undergo to PC-based neurorehabilitation intervention. This intervention will train research subjects to improve movement initiation in response to visual stimuli.
Behavioral: PC based training
Subjects sit at a computer and type a string of numbers that appears on the screen. As performance improves (# correct), the strings of numbers get longer. They are then instructed to repeat the string from memory. Performing these key entries from memory is a test of internally generated movement initiation.
Other Name: training
Active Comparator: Control Subjects
Age matched controls who undergo to PC-based neurorehabilitation intervention. This intervention will train research subjects to improve movement initiation in response to visual stimuli.
Behavioral: PC based training
Subjects sit at a computer and type a string of numbers that appears on the screen. As performance improves (# correct), the strings of numbers get longer. They are then instructed to repeat the string from memory. Performing these key entries from memory is a test of internally generated movement initiation.
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   (Adult, Senior)
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

Sponsors and Collaborators
VA Office of Research and Development
Louisiana State University Health Sciences Center Shreveport
Investigators
Principal Investigator: Elizabeth A Disbrow, PhD Overton Brooks VA Medical Center, Shreveport, LA
  More Information

Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01085968     History of Changes
Other Study ID Numbers: E7185-R 
Study First Received: March 10, 2010
Results First Received: July 5, 2016
Last Updated: August 16, 2016
Health Authority: United States: Federal Government
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data will be available upon request.

Keywords provided by VA Office of Research and Development:
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 December 05, 2016