NCT04928027

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 8, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 9, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 16, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2022

Completed
Last Updated

June 22, 2021

Status Verified

June 1, 2021

Enrollment Period

1 year

First QC Date

June 9, 2021

Last Update Submit

June 15, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Comparison of EF outcomes

    Results of the self-reports of persons with PD and their Significant Others will be compared.

    1 year

Study Arms (2)

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

Eligibility Criteria

Age30 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • For persons with PD,confirmed diagnosis of PD) For significant others - relationship with person with PD

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Old Dominion University

Norfolk, Virginia, 23508, United States

RECRUITING

MeSH Terms

Conditions

Parkinsonian DisordersParkinson Disease

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Central Study Contacts

Jane Roitsch, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 9, 2021

First Posted

June 16, 2021

Study Start

June 8, 2021

Primary Completion

June 8, 2022

Study Completion

June 8, 2022

Last Updated

June 22, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

No other researchers will received participant data information

Locations