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Cognitive Rehabilitation in Parkinson's Disease

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
PC based training
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Parkinson's Disease focused on measuring Parkinson's disease, Cognitive deficits, fMRI, neuro rehabilitation, Age Matched Controls

Eligibility Criteria

55 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    PD Subjects

    Control Subjects

    Arm Description

    PD subjects who undergo to PC-based neurorehabilitation intervention. This intervention will train research subjects to improve movement initiation in response to visual stimuli.

    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.

    Outcomes

    Primary Outcome Measures

    Reaction Time and Variability for Movement Task
    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
    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
    Left, right and bimanual errors in external cue and internally generated tasks for four-digit trials
    Functional Dexterity Test (FDT)
    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)
    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.

    Full Information

    First Posted
    March 10, 2010
    Last Updated
    August 16, 2016
    Sponsor
    VA Office of Research and Development
    Collaborators
    Louisiana State University Health Sciences Center Shreveport
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01085968
    Brief Title
    Cognitive Rehabilitation in Parkinson's Disease
    Official Title
    PC-based Rehabilitation of Motor Planning Deficits in Parkinson Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2010 (undefined)
    Primary Completion Date
    August 2015 (Actual)
    Study Completion Date
    August 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    VA Office of Research and Development
    Collaborators
    Louisiana State University Health Sciences Center Shreveport

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson's Disease
    Keywords
    Parkinson's disease, Cognitive deficits, fMRI, neuro rehabilitation, Age Matched Controls

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    54 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PD Subjects
    Arm Type
    Experimental
    Arm Description
    PD subjects who undergo to PC-based neurorehabilitation intervention. This intervention will train research subjects to improve movement initiation in response to visual stimuli.
    Arm Title
    Control Subjects
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    PC based training
    Other Intervention Name(s)
    training
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Reaction Time and Variability for Movement Task
    Description
    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.
    Time Frame
    time of enrollment and 2 months following enrollment (before and after training)
    Secondary Outcome Measure Information:
    Title
    Neuropsychological Measures of Cognitive Function, Including Reaction Time and Time to Completion
    Description
    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.
    Time Frame
    time of enrollment and 2 months following enrollment (before and after training)
    Title
    Task Errors and Variability
    Description
    Left, right and bimanual errors in external cue and internally generated tasks for four-digit trials
    Time Frame
    time of enrollment and 2 months following enrollment (before and after training)
    Title
    Functional Dexterity Test (FDT)
    Description
    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.
    Time Frame
    time of enrollment and 2 months following enrollment (before and after training)
    Title
    Symbol Digit Modality Test (SDMT)
    Description
    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.
    Time Frame
    time of enrollment and 2 months following enrollment (before and after training)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    55 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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 Depression or daytime sleepiness
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Elizabeth A Disbrow, PhD
    Organizational Affiliation
    Overton Brooks VA Medical Center, Shreveport, LA
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    De-identified individual participant data will be available upon request.
    Citations:
    PubMed Identifier
    22459048
    Citation
    Disbrow EA, Russo KA, Higginson CI, Yund EW, Ventura MI, Zhang L, Malhado-Chang N, Woods DL, Sigvardt KA. Efficacy of tailored computer-based neurorehabilitation for improvement of movement initiation in Parkinson's disease. Brain Res. 2012 May 3;1452:151-64. doi: 10.1016/j.brainres.2012.02.073. Epub 2012 Mar 9.
    Results Reference
    result

    Learn more about this trial

    Cognitive Rehabilitation in Parkinson's Disease

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