search
Back to results

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

Primary Purpose

Parkinson's Disease, Mild Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brain Fitness
InSight
Active Control
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's Disease, Mild Cognitive Impairment

Eligibility Criteria

21 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Virginia Commonwealth University Parkinson's and Movement Disorders Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Brain Fitness

InSight

Active Control

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Parkinson's Disease Quality of Life Questionnaire-39 (PDQ-39)
Change in PDQ-39 scores from baseline to 3 month follow up.
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

Full Information

First Posted
August 19, 2014
Last Updated
January 6, 2016
Sponsor
Virginia Commonwealth University
search

1. Study Identification

Unique Protocol Identification Number
NCT02225314
Brief Title
Computer-based Cognitive Training for Individuals With Parkinson's Disease
Official Title
Computer-based Cognitive Training for Individuals With Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Mild Cognitive Impairment
Keywords
Parkinson's Disease, Mild Cognitive Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brain Fitness
Arm Type
Experimental
Arm Description
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.
Arm Title
InSight
Arm Type
Experimental
Arm Description
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.
Arm Title
Active Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Brain Fitness
Intervention Description
Brain Fitness is a computer-based cognitive training programs that consists of six types of exercises that train auditory processing speed and accuracy.
Intervention Type
Behavioral
Intervention Name(s)
InSight
Intervention Description
InSight is a computer-based cognitive training program that consists of five types of exercises that train visual processing and working memory.
Intervention Type
Behavioral
Intervention Name(s)
Active Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent Accuracy on Cognitive Training Quizzes
Description
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.
Time Frame
Immediate Post-Intervention
Secondary Outcome Measure Information:
Title
Parkinson's Disease Quality of Life Questionnaire-39 (PDQ-39)
Description
Change in PDQ-39 scores from baseline to 3 month follow up.
Time Frame
Change from Baseline to 3 Month Follow Up in PDQ-39
Title
California Verbal Learning Test-II Long Delay Free Recall Scaled Score Change Over 3 Months
Description
Change from California Verbal Learning Test-II Long Delay Free Recall Scaled Score from Baseline and 3 Months
Time Frame
Change from Baseline in California Verbal Learning Test-II Long Delay Free Recall Scaled Score at 3 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah K. Lageman, Ph.D.
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University Parkinson's and Movement Disorders Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs