Computer-based Cognitive Training for Individuals With Parkinson's Disease

Study Overview
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Brief Summary
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Computer-Based Cognitive Training for Individuals with Parkinson's Disease is a 3-arm randomized controlled trial (RCT) comparing Brain Fitness, InSight, and an active control (AC) training program to evaluate the feasibility of empirically supported computer-based cognitive training programs (CCTPs) for patients diagnosed with Parkinson's disease (PD) with Mild Cognitive Impairment (MCI). This pilot study aims to address the need for increased interventions to target non-motor symptoms associated with PD.

Detailed Description
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Patients meeting criteria for MCI will be initially randomized to one of the 3 conditions. Participants will complete cognitive training exercises on their home or clinic-provided computers for 60 minutes per day, 5 days per week. Compliance and performance will be monitored on a weekly basis and at completion of the study. Outcome measures will be collected one week before initiation of the intervention and within one week completion of the intervention. Neuropsychological functioning, including tests of processing speed, attention, and executive functioning, will serve as primary outcome measures. Patient reported outcomes, including measures of overall QOL and disease-specific QOL, and support-person reported outcomes (if applicable), including measures of overall QOL and caregiver burden, will be secondary outcome measures. This pilot study promises to evaluate computer-based cognitive training in a novel population and expand access to cognitive rehabilitation services, and is designed to improve cognitive functioning and QOL among a wide range of individuals with PD.

Official Title
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Computer-based Cognitive Training for Individuals With Parkinson's Disease

Conditions
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Parkinson's Disease, Mild Cognitive Impairment

Intervention / Treatment
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* Behavioral: Brain Fitness
* Behavioral: InSight
* Behavioral: Active Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants eligible for this study must speak English and have a confirmed medical diagnosis of Parkinson's disease and meet established criteria for MCI in PD (Litvan et al., 2012), defined as individuals with performances of approximately -1 to -2 standard deviations below the mean on at least two tests within five cognitive domains assessed in their clinical neuropsychological evaluations. Exclusion Criteria: Exclusion criteria include diagnosis of PD dementia based on Movement Disorder Society Task Force criteria (Emre et al., 2007) and other PD-associated comorbid conditions (e.g., severe anxiety, depression, excessive daytime sleepiness, or psychosis) that significantly influence cognitive testing (Litvan et al., 2012).

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brain Fitness<br>Brain Fitness is a computer-based cognitive training programs designed to augment auditory processing speed and accuracy over an 8-week period to individuals with PD and MCI at a community Parkinson's and Movement Disorders specialty clinic. | Behavioral: Brain Fitness<br>* Brain Fitness is a computer-based cognitive training programs that consists of six types of exercises that train auditory processing speed and accuracy.<br>|
| Experimental: InSight<br>InSight is a computer-based cognitive training programs designed to augment visual processing and working memory over an 8-week period to individuals with PD and MCI at a community Parkinson's and Movement Disorders specialty clinic. | Behavioral: InSight<br>* InSight is a computer-based cognitive training program that consists of five types of exercises that train visual processing and working memory.<br>|
| Active Comparator: Active Control<br>An active control arm is necessary to model practice effects in an untreated group. Participants in this group will view and complete quizzes on a computerized learning program designed to improve knowledge about literature, art, and history. | Behavioral: Active Control<br>* The Active Control arm is a computerized learning program that consists of five programs (i.e., Wright Brothers, History of Britain, Sister Wendy's American Collection, In Search of Shakespeare, and View the Cosmos) designed to improve knowledge about literature, art, and history.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Accuracy on Cognitive Training Quizzes | Percent accuracy of cognitive training quizzes from the cognitive training programs of the RCT will be compared. The quizzes are specific to each cognitive training program. The Brain Fitness quiz is comprised of auditory processing and accuracy tasks. The InSight quiz is comprised of visual processing and working memory tasks. The Active Control quiz is comprised of questions about knowledge, literature, art, and history. Due to the differences between the arms with regards to content, the percent accuracy for each participant will be the outcome measure compared across the three study arms. | Immediate Post-Intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parkinson's Disease Quality of Life Questionnaire-39 (PDQ-39) | Change in PDQ-39 scores from baseline to 3 month follow up. | Change from Baseline to 3 Month Follow Up in PDQ-39 | 
| California Verbal Learning Test-II Long Delay Free Recall Scaled Score Change Over 3 Months | Change from California Verbal Learning Test-II Long Delay Free Recall Scaled Score from Baseline and 3 Months | Change from Baseline in California Verbal Learning Test-II Long Delay Free Recall Scaled Score at 3 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's Disease, Mild Cognitive Impairment