Brain Fitness in Parkinson's Disease
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
InSight
No contact-control group
Sponsored by
About this trial
This is an interventional prevention trial for Parkinson's Disease focused on measuring brain fitness, cognitive training, cognitive intervention, speed of processing training, Parkinson's disease
Eligibility Criteria
Inclusion Criteria:
- Criteria will be age 40 years or older and clinical diagnosis of idiopathic PD in Hoehn and Yahr stages 1 to 3, and on a stable medication regimen (no expected changes in next six months). Subjects with random or severe motor fluctuations and dyskinesias will be excluded. Further inclusion criteria will be no diagnosis of dementia nor evidence of severe dementia that may limit ability to benefit from training, and adequate visual acuity to view testing and training stimuli (far visual acuity >= 20/80).
Sites / Locations
- University of South Florida
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
InSight Brain Fitness
No contact-control
Arm Description
Outcomes
Primary Outcome Measures
Useful Field of View
A measure of visual processing speed independent of motor speed.
Secondary Outcome Measures
Depressive Symptoms
GDS and CES-D
CSRQ
Quality of Life measure
Full Information
NCT ID
NCT01155349
First Posted
June 29, 2010
Last Updated
December 7, 2012
Sponsor
University of South Florida
1. Study Identification
Unique Protocol Identification Number
NCT01155349
Brief Title
Brain Fitness in Parkinson's Disease
Official Title
Cognitive Speed of Processing Training Among Persons With Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Florida
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to examine the feasibility and potential effectiveness of a cognitive training program among persons with Parkinson's disease. It is hypothesized that individuals with PD will be able to complete and benefit from the intervention.
Detailed Description
Parkinson's Disease (PD) affects about 1 million individuals in the United States. In addition to the typical motor dysfunction, PD also affects cognition and vision, even in early stages of the disease, impairing instrumental activities of daily living such as driving. Reduced cognitive speed of processing, or bradyphrenia, strongly contributes to cognitive decline in PD. Recent research has demonstrated that interventions can enhance cognitive speed of processing, protect against further cognitive decline, and improve the everyday functioning of relatively healthy, older adults. However, the potential of such training techniques to enhance cognitive functions among subpopulations with different disease states, such as PD, has not been thoroughly investigated. The proposed study will further examine the feasibility and test the efficacy of a well-established cognitive training tool among individuals in the early stages of PD who have not been diagnosed with dementia. A variety of factors have been found to influence cognitive performance among persons with PD and may moderate their ability to benefit from cognitive training such as age at disease onset, disease duration, manifestation, severity, and medication use as well as concomitant depression. These factors along with demographic variables will be evaluated as moderators of training benefit. Baseline cognitive assessments will be completed among seventy-five individuals with PD who will be randomized to cognitive training or a treatment-delayed control condition. The efficacy of training to immediately enhance cognitive functioning will be evaluated through a post-training (or equivalent delay) assessment. Disease and demographic factors that may impact the efficacy of cognitive training for persons with PD will be examined in relation to training gains. Considering that cognitive function among individuals with PD is a strong predictor of everyday functioning and subsequent need for long term care, enhancing cognitive function of individuals with PD through training has great potential to prolong such persons' productivity, independence, and quality of life. The information gained from this study will be useful for identifying individuals with PD who are most likely to benefit from cognitive training as well as the development, refinement, and implementation of appropriate cognitive interventions for this population.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
brain fitness, cognitive training, cognitive intervention, speed of processing training, Parkinson's disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
87 (Actual)
8. Arms, Groups, and Interventions
Arm Title
InSight Brain Fitness
Arm Type
Experimental
Arm Title
No contact-control
Arm Type
Placebo Comparator
Intervention Type
Behavioral
Intervention Name(s)
InSight
Intervention Description
A cognitive intervention designed to enhance speed of visual processing.
Intervention Type
Other
Intervention Name(s)
No contact-control group
Intervention Description
No contact-control group.
Primary Outcome Measure Information:
Title
Useful Field of View
Description
A measure of visual processing speed independent of motor speed.
Time Frame
3 and 6 months
Secondary Outcome Measure Information:
Title
Depressive Symptoms
Description
GDS and CES-D
Time Frame
3 and 6 months
Title
CSRQ
Description
Quality of Life measure
Time Frame
3 and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Criteria will be age 40 years or older and clinical diagnosis of idiopathic PD in Hoehn and Yahr stages 1 to 3, and on a stable medication regimen (no expected changes in next six months). Subjects with random or severe motor fluctuations and dyskinesias will be excluded. Further inclusion criteria will be no diagnosis of dementia nor evidence of severe dementia that may limit ability to benefit from training, and adequate visual acuity to view testing and training stimuli (far visual acuity >= 20/80).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jerri D Edwards, Ph.D.
Organizational Affiliation
University of South Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33620
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Brain Fitness in Parkinson's Disease
We'll reach out to this number within 24 hrs