Clinical trial NCT02225314: 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
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Mild Cognitive Impairment
Keywords: Parkinson's Disease
Mild Cognitive Impairment
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2014-08-26
Enrollment: 25
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Percent Accuracy on Cognitive Training Quizzes
timeFrame: Immediate Post-Intervention
Secondary outcomes:
measure: Parkinson's Disease Quality of Life Questionnaire-39 (PDQ-39)
timeFrame: Change from Baseline to 3 Month Follow Up in PDQ-39
measure: California Verbal Learning Test-II Long Delay Free Recall Scaled Score Change Over 3 Months
timeFrame: Change from Baseline in California Verbal Learning Test-II Long Delay Free Recall Scaled Score at 3 Months
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University Parkinson's and Movement Disorders Center
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Sarah K. Lageman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: