- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04928027
Self-Reports of Executive Functions in Persons With Parkinson's Disease and Their Significant Others
The investigators are conducting a study to compare the self-reports of executive functions (that is to say, what role cognitive processes such as working memory and attention) in persons with Parkinson's Disease to the reports of executive functions completed by their significant others.
To conduct this study, the investigators need the participation of persons who are diagnosed with Parkinson's Disease and their significant others.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Jane Roitsch, PhD
- Phone Number: 2163347628
- Email: jroitsch@odu.edu
Study Locations
-
-
Virginia
-
Norfolk, Virginia, United States, 23508
- Recruiting
- Old Dominion University
-
Contact:
- Jane Roitsch
- Phone Number: 216-334-7628
- Email: jroitsch@odu.edu
-
Contact:
- Jane Roitsch
- Phone Number: 2163347628
- Email: jroitsch@odu.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Parkinson's group: Adults with a Parkinson's disease diagnosis and their significant others.
Healthy elderly: no history of neurologic disease (e.g., stroke, traumatic brain injury)
Both groups:
Age 30-79 years with no history of other neurologic diseases, orthopedic, or arthritic conditions that preclude ability to walk
Some of the earliest cognitive symptoms of Parkinsonism involve executive function deficits (e.g., working memory, cognitive flexibility, planning; Williams-Gray, Foltynie, Lewis, and Barker, 2006). What is less understood, however, is whether a relationship exists between the self-reported EFs in persons with Parkinsonism and their significant others. The need for research to investigate the relationship between EFs in persons with Parkinsonism is evident in the limited body of literature currently available.
Description
Inclusion Criteria:
- For persons with PD,confirmed diagnosis of PD) For significant others - relationship with person with PD
Exclusion Criteria:All participants will be screened to ensure they do not have:
- any known cognitive disorders other than those associated with PD
- impairments in vision that would affect their ability to safely participate in the study
- recent history of neuromuscular injury/ damage that could affect their ability to complete the CEFI
- the participant will be excluded if he or she is unable to follow commands well enough to complete the CEFI
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
---|
Persons with PD
Adults with PD will be provided with email link to complete the Comprehensive Executive Function Inventory-Self-Assessment
|
Significant Others of those with PD
Adults whose significant other has a diagnosis of PD will be provided with email link to complete the Comprehensive Executive Function Inventory-Observer report
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of EF outcomes
Time Frame: 1 year
|
Results of the self-reports of persons with PD and their Significant Others will be compared.
|
1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EFs and PD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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