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

NCT02225314 | Completed

• 1 other identifier: ADWilliams2012-647173
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease; Mild Cognitive Impairment

Keywords

Parkinson's Disease; Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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 Arms (3)

Brain Fitness

EXPERIMENTAL

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

InSight

EXPERIMENTAL

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

Active Control

ACTIVE COMPARATOR

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

Interventions

Brain Fitness BEHAVIORAL

Brain Fitness is a computer-based cognitive training programs that consists of six types of exercises that train auditory processing speed and accuracy.

Brain Fitness

InSight BEHAVIORAL

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

InSight

Active Control BEHAVIORAL

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.

Active Control

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University Parkinson's and Movement Disorders Center

Richmond, Virginia, 23230, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Sarah K. Lageman, Ph.D.

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2014
• First Posted: August 26, 2014
• Study Start: April 1, 2012
• Primary Completion: October 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 8, 2016

Record last verified: 2016-01

Locations

US (1)