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Clinical Trials/NCT02225314
NCT02225314
Completed
Not Applicable

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

Virginia Commonwealth University1 site in 1 country25 target enrollmentApril 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson's Disease
Sponsor
Virginia Commonwealth University
Enrollment
25
Locations
1
Primary Endpoint
Percent Accuracy on Cognitive Training Quizzes
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
April 2012
End Date
December 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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).

Outcomes

Primary Outcomes

Percent Accuracy on Cognitive Training Quizzes

Time Frame: Immediate Post-Intervention

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.

Secondary Outcomes

  • Parkinson's Disease Quality of Life Questionnaire-39 (PDQ-39)(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 Baseline in California Verbal Learning Test-II Long Delay Free Recall Scaled Score at 3 Months)

Study Sites (1)

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