Parkinsonism or Parkinson's Disease NosNCT04928027
Self-Reports of Executive Functions in Persons With Parkinson's Disease and Their Significant Others
An observational study of Parkinsonism or Parkinson's Disease Nos, run by Old Dominion University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinsonism or Parkinson's Disease Nos
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2021to 8 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Old Dominion University
Norfolk, Virginia, 23508
Jane Roitsch, 216-334-7628, jroitsch@odu.edu
Jane Roitsch, 2163347628, jroitsch@odu.edu
About this study
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.
Read the detailed description
The purpose of this study is to explore the relationship between the self-reported executive functions (EFs) in persons with Parkinsons disease (PD) and their significant others. Executive functions include basic cognitive processes such as attention, inhibition, working memory, and cognitive flexibility. As this proposed study will test not only cognitive functioning, but specific aspects of it (i.e., EFs) without excluding persons with PD who have identified cognitive impairments, outcomes gathered could provide valuable information to better assist all types of persons with PD. Comparing their self-reported EFs to the EF ratings completedy by their signifiant others can help determine if a disparity exists between self-perceptions and actual observed EF abilties. This study would assess EFs through inhibition responses of participants via computerized versions the Comprehensive Executive Function Inventory-Adult Self-Report and Observer forms.
- Conditions
- Parkinsonism or Parkinson's Disease Nos
- Medical subject headings
- Parkinsonian Disorders, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Comparison of EF outcomes
Results of the self-reports of persons with PD and their Significant Others will be compared.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study start8 Jun 2021
- Primary completion8 Jun 2022 (estimated)
- Study completion8 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinsonism or Parkinson's Disease NosStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Old Dominion University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jane Roitsch, Old Dominion University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04928027
- Sponsor's protocol ID
- EFs and PD
- Status last verified
- Jun 2021
- First submitted
- 9 Jun 2021
- Last updated
- 22 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No other researchers will received participant data information
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Reports of Executive Functions in Persons With Parkinson's Disease and Their Significant Others
- ClinicalTrials.gov ID
- NCT04928027
- Acronym / sponsor ID
- EFs and PD
- Conditions
- Parkinsonism or Parkinson's Disease Nos
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Old Dominion UniversityUniversity, hospital or other
- Study start
- 8 Jun 2021 (actual)
- Primary completion
- 8 Jun 2022 (estimated)
- Study completion
- 8 Jun 2022 (estimated)
- First posted
- 16 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of this study is to explore the relationship between the self-reported executive functions (EFs) in persons with Parkinsons disease (PD) and their significant others. Executive functions include basic cognitive processes such as attention, inhibition, working memory, and cognitive flexibility. As this proposed study will test not only cognitive functioning, but specific aspects of it (i.e., EFs) without excluding persons with PD who have identified cognitive impairments, outcomes gathered could provide valuable information to better assist all types of persons with PD. Comparing their self-reported EFs to the EF ratings completedy by their signifiant others can help determine if a disparity exists between self-perceptions and actual observed EF abilties. This study would assess EFs through inhibition responses of participants via computerized versions the Comprehensive Executive Function Inventory-Adult Self-Report and Observer forms.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 30 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- For persons with PD,confirmed diagnosis of PD) For significant others - relationship with person with PD
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of EF outcomes
Time frame: 1 year
Results of the self-reports of persons with PD and their Significant Others will be compared.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2021.
- Individual participant dataSharing planned: No. No other researchers will received participant data information
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinsonism or Parkinson's Disease Nos, run by Old Dominion University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jane Roitsch, PhD (2163347628, jroitsch@odu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of EF outcomes (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2021.