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
  Purpose

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 Intervention Phase
Parkinson's Disease
Behavioral: InSight
Other: No contact-control group
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Cognitive Speed of Processing Training Among Persons With Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 87
Study Start Date: July 2009
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01155349

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

No publications provided

Responsible Party: Jerri D. Edwards, Associate Professor, University of South Florida
ClinicalTrials.gov Identifier: NCT01155349     History of Changes
Other Study ID Numbers: USF105832
Study First Received: June 29, 2010
Last Updated: December 7, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on August 28, 2014