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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02225314
• Other study ID #: ADWilliams2012-647173
• Status: Completed
• Phase: N/A
• First received: August 19, 2014
• Last updated: January 6, 2016
• Start date: April 2012
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognition Disorders
• Mild Cognitive Impairment
• Parkinson Disease
• Parkinson's Disease

Intervention

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.
• InSight
InSight is a computer-based cognitive training program that consists of five types of exercises that train visual processing and working memory.
• 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.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University Parkinson's and Movement Disorders Center	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No