Brain Fitness in Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

Cognitive Speed of Processing Training Among Persons With Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01155349
• Other study ID #: USF105832
• Status: Completed
• Phase: Phase 3
• First received: June 29, 2010
• Last updated: December 7, 2012
• Start date: July 2009
• Est. completion date: May 2012

Study information

• Verified date: December 2012
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Behavioral:
• InSight
A cognitive intervention designed to enhance speed of visual processing.

Other:
• No contact-control group
No contact-control group.

Locations

Country	Name	City	State
United States	University of South Florida	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Useful Field of View	A measure of visual processing speed independent of motor speed.	3 and 6 months	No
Secondary	Depressive Symptoms	GDS and CES-D	3 and 6 months	No
Secondary	CSRQ	Quality of Life measure	3 and 6 months	No