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| Name | Class |
|---|---|
| Louisiana State University Health Sciences Center Shreveport | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PD Subjects | Experimental | PD subjects who undergo to PC-based neurorehabilitation intervention. This intervention will train research subjects to improve movement initiation in response to visual stimuli. |
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| Control Subjects | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PC based training | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | time of enrollment and 2 months following enrollment (before and after training) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth A Disbrow, PhD | Overton Brooks VA Medical Center, Shreveport, LA | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22459048 | Result | 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. |
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De-identified individual participant data will be available upon request.
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Participants were assigned to group depending on disease status
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| ID | Title | Description |
|---|---|---|
| FG000 | PD Subjects | PD subjects 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. |
| FG001 | Control Subjects | Age matched controls 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Multivariate Analysis of Variance was performed to identify differences across groups in baseline characteristics
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| ID | Title | Description |
|---|---|---|
| BG000 | PD Subjects | PD subjects 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. |
| BG001 | Control Subjects |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | PD Subjects: total number of subjects: 29, 8 withdrew from study, 2 had incomplete data. CO Subjects: total number of subjects: 25, 4 withdrew from study | Posted | Mean | Standard Deviation | milliseconds | time of enrollment and 2 months following enrollment (before and after training) |
|
Adverse events were monitored for each research participant over the 10-12 week period during which data was collected.
The most likely time that adverse events would be reported was during the 6 weeks of neurorehabilitation training.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PD Subjects | PD subjects 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Disbrow | VA Overton Brooks | 318-6757184 | edisbr@lsuhsc.edu |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D003072 | Cognition Disorders |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| time of enrollment and 2 months following enrollment (before and after training) |
| Task Errors and Variability | Left, right and bimanual errors in external cue and internally generated tasks for four-digit trials | time of enrollment and 2 months following enrollment (before and after training) |
| 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. | time of enrollment and 2 months following enrollment (before and after training) |
| 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. | time of enrollment and 2 months following enrollment (before and after training) |
Age matched controls 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Control Subjects | Age matched controls 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. |
|
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| Secondary | 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. | Posted | Mean | Standard Deviation | Seconds | time of enrollment and 2 months following enrollment (before and after training) |
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| Secondary | Task Errors and Variability | Left, right and bimanual errors in external cue and internally generated tasks for four-digit trials | Posted | Mean | Standard Deviation | Number of Errors | time of enrollment and 2 months following enrollment (before and after training) |
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|
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| Secondary | 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. | Posted | Mean | Standard Deviation | Seconds | time of enrollment and 2 months following enrollment (before and after training) |
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|
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| Secondary | 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. | Posted | Mean | Standard Deviation | Number of Correct Matches in 90 seconds | time of enrollment and 2 months following enrollment (before and after training) |
|
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| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | Control Subjects | Age matched controls 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. | 0 | 25 | 0 | 25 |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| Before-mEFAP Task 3 |
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| Before-mEFAP Task 4 |
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| Before-mEFAP Task 5 |
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| After-mEFAP Task 1 |
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| After-mEFAP Task 2 |
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| After-mEFAP Task 3 |
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| After-mEFAP Task 4 |
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| After-mEFAP Task 5 |
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| Before-mEFAP Total |
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| After-mEFAP Total |
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| Before-Bimanual External Cue Errors |
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| Before-Left Internally Generated Errors |
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| Before-Right Internally Generated Errors |
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| Before-Bimanual Internally Generated Errors |
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| After-Left External Cue Errors |
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| After-Right External Cue Errors |
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| After-Bimanual External Cue Errors |
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| After-Left Internally Generated Errors |
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| After-Right Internally Generated Errors |
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| After-Bimanual Internally Generated Errors |
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| Before-Non-dominant Hand 1 |
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| Before-Non-dominant Hand 2 |
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| Before-Modified Task 1 |
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| Before-Modified Task 2 |
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| Before-Combined Modified Task |
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| Before-Dominant Hand Average |
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| Before-Non-dominant Average |
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| After-Dominant Hand 1 |
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| After-Dominant Hand 2 |
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| After-Non-dominant Hand 1 |
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| After-Non-dominant Hand 2 |
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| After-Modified Task 1 |
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| After-Modified Task 2 |
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| After-Combined Modified Task |
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| After-Dominant Average |
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| After-Non-dominant Average |
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