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Brain Fitness in Parkinson's Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jerri D. Edwards, University of South Florida
ClinicalTrials.gov Identifier:
NCT01155349
First received: June 29, 2010
Last updated: December 7, 2012
Last verified: December 2012

June 29, 2010
December 7, 2012
July 2009
May 2012   (final data collection date for primary outcome measure)
Useful Field of View [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
A measure of visual processing speed independent of motor speed.
Same as current
Complete list of historical versions of study NCT01155349 on ClinicalTrials.gov Archive Site
  • Depressive Symptoms [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
    GDS and CES-D
  • CSRQ [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
    Quality of Life measure
Same as current
Not Provided
Not Provided
 
Brain Fitness in Parkinson's Disease
Cognitive Speed of Processing Training Among Persons With Parkinson's Disease

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Parkinson's Disease
  • Behavioral: InSight
    A cognitive intervention designed to enhance speed of visual processing.
  • Other: No contact-control group
    No contact-control group.
  • Experimental: InSight Brain Fitness
    Intervention: Behavioral: InSight
  • Placebo Comparator: No contact-control
    Intervention: Other: No contact-control group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
87
May 2012
May 2012   (final data collection date for primary outcome measure)

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).
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01155349
USF105832
No
Jerri D. Edwards, University of South Florida
University of South Florida
Not Provided
Principal Investigator: Jerri D Edwards, Ph.D. University of South Florida
University of South Florida
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP