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
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
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
NCT ID
NCT01085968
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
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
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Cognitive Rehabilitation in Parkinson's Disease
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