Brain Fitness in Parkinson's Disease

• ClinicalTrials.gov Identifier: NCT01155349
• Recruitment Status: Completed
• First Posted: July 1, 2010
• Last Update Posted: December 10, 2012
• Sponsor: University of South Florida
• Information provided by (Responsible Party): Jerri D. Edwards, University of South Florida

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.

Condition or disease	Intervention/treatment	Phase
Parkinson's Disease	Behavioral: InSight; Other: No contact-control group	Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 87 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Prevention
• Official Title: Cognitive Speed of Processing Training Among Persons With Parkinson's Disease
• Study Start Date: July 2009
• Actual Primary Completion Date: May 2012
• Actual Study Completion Date: May 2012

Arms and Interventions

Arm	Intervention/treatment
Experimental: InSight Brain Fitness	Behavioral: InSight; A cognitive intervention designed to enhance speed of visual processing.
Placebo Comparator: No contact-control	Other: No contact-control group; No contact-control group.

Outcome Measures

Primary Outcome Measures :

1. Useful Field of View [ Time Frame: 3 and 6 months ]
   A measure of visual processing speed independent of motor speed.

Secondary Outcome Measures :

1. Depressive Symptoms [ Time Frame: 3 and 6 months ]
   GDS and CES-D
2. CSRQ [ Time Frame: 3 and 6 months ]
   Quality of Life measure

Eligibility Criteria

• Ages Eligible for Study: 40 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

United States, Florida

University of South Florida

Tampa, Florida, United States, 33620

Sponsors and Collaborators

University of South Florida

Investigators

• Principal Investigator: Jerri D Edwards, Ph.D.; University of South Florida

More Information

• Responsible Party: Jerri D. Edwards, Associate Professor, University of South Florida
• ClinicalTrials.gov Identifier: NCT01155349
• Other Study ID Numbers: USF105832
• First Posted: July 1, 2010
• Last Update Posted: December 10, 2012
• Last Verified: December 2012

Keywords provided by Jerri D. Edwards, University of South Florida:

brain fitness; cognitive training; cognitive intervention; speed of processing training; Parkinson's disease

Additional relevant MeSH terms:

Parkinson Disease; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Neurodegenerative Diseases