MedDataX Logo

Brain Fitness in Parkinson's Disease

NCT ID: NCT01155349

Last Updated: 2012-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2012-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Parkinson's Disease

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

InSight Brain Fitness

Group Type EXPERIMENTAL

InSight

Intervention Type BEHAVIORAL

A cognitive intervention designed to enhance speed of visual processing.

No contact-control

Group Type PLACEBO_COMPARATOR

No contact-control group

Intervention Type OTHER

No contact-control group.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

InSight

A cognitive intervention designed to enhance speed of visual processing.

Intervention Type BEHAVIORAL

No contact-control group

No contact-control group.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion 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).
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of South Florida

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jerri D. Edwards

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jerri D Edwards, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of South Florida

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of South Florida

Tampa, Florida, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

USF105832

Identifier Type: -

Identifier Source: org_study_id