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

January 6, 2016 updated by: Virginia Commonwealth University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23230
        • Virginia Commonwealth University Parkinson's and Movement Disorders Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Brain Fitness
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
Brain Fitness is a computer-based cognitive training programs that consists of six types of exercises that train auditory processing speed and accuracy.
Experimental: InSight
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
InSight is a computer-based cognitive training program that consists of five types of exercises that train visual processing and working memory.
Active Comparator: Active Control
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Immediate Post-Intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parkinson's Disease Quality of Life Questionnaire-39 (PDQ-39)
Time Frame: Change from Baseline to 3 Month Follow Up in 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
Time Frame: Change from Baseline in California Verbal Learning Test-II Long Delay Free Recall Scaled Score at 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Commonwealth University

Investigators

  • Principal Investigator: Sarah K. Lageman, Ph.D., Virginia Commonwealth University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

August 19, 2014

First Submitted That Met QC Criteria

August 22, 2014

First Posted (Estimate)

August 26, 2014

Study Record Updates

Last Update Posted (Estimate)

January 8, 2016

Last Update Submitted That Met QC Criteria

January 6, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADWilliams2012-647173

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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