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Brain Fitness in Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01155349
Recruitment Status : Completed
First Posted : July 1, 2010
Last Update Posted : December 10, 2012
Information provided by (Responsible Party):
Jerri D. Edwards, University of South Florida

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.

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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

Resource links provided by the National Library of Medicine

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.

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

Information from the National Library of Medicine

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

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01155349

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United States, Florida
University of South Florida
Tampa, Florida, United States, 33620
Sponsors and Collaborators
University of South Florida
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Principal Investigator: Jerri D Edwards, Ph.D. University of South Florida
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Responsible Party: Jerri D. Edwards, Associate Professor, University of South Florida Identifier: NCT01155349    
Other Study ID Numbers: USF105832
First Posted: July 1, 2010    Key Record Dates
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:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases