Parkinson DiseaseNCT03241966
Perception, Cognition, and Gait in Parkinson's Disease
An observational study of Parkinson Disease, run by Boston University Charles River Campus at 1 site in United States.
Trial summary
The investigators are examining how aspects of daily function are perceived in persons with PD and in those who interact with them on a regular basis. If eligible, participants will receive a set of online questionnaires by email. Read more about this study
- Who is it for?
- Ages 40 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- How many people
- 439 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2017to 15 Jan 2019
- 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 40 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants are accepted regardless of location, community, clinic, etc.
Who may be able to join
- Diagnosed with Parkinson's disease without dementia OR close associate of someone with Parkinson's disease
- 40 years or older
- Proficient English speaker
- Access to a computer
- 8+ years of education
Who cannot join
- Co-existing active neoplasm, serious cardiac disease, other serious chronic medical illness
- Prior intracranial surgery
- History of traumatic brain injury
- Psychiatric or neurological diagnoses other than Parkinson's disease
- History of alcoholism or other drug abuse
- History of treatment with electroshock therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Vision and Cognition Laboratory at Boston University
Boston, Massachusetts, 02215
About this study
The investigators are examining how aspects of daily function are perceived in persons with PD and in those who interact with them on a regular basis. If eligible, participants will receive a set of online questionnaires by email. The questionnaires will take about 1 hour to complete, and can be done at the participant's convenience. The investigators are looking for volunteers who have a diagnosis of Parkinson's disease without dementia (age 40 or older and proficient English speakers). If a spouse, family member, significant other or other close associate is available (age 18 or older, proficient English speakers), the investigators will send them questionnaires as well. There is no monetary or other compensation for this study. For more information, please contact the Vision and Cognition Laboratory at vcognition@gmail.com or 617-358-1377.
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's Disease, Online Study, Quality of Life, Activities of Daily Living, Perception, Cognition, Gait
- Medical subject headings
- 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 |
|---|---|---|
| People with Parkinson's Disease | Individuals diagnosed with idiopathic Parkinson's disease without dementia. | |
| Informant | Family member, spouse, significant other, caregiver, or other close associate of someone with Parkinson's disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parkinson's Disease Questionnaire (PDQ-39)
Measures the health status of Parkinson's disease patients and the impact the disease has on their aspects of daily living. There are 39 items.
Measured: Within 24 hours of starting the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2017
- Study start1 Apr 2017
- Primary completion15 Jan 2019
- Study completion15 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 439 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alice Cronin-Golomb, Boston University Charles River Campus
- Investigators
- Alice Cronin-Golomb, Ph.D., Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03241966
- Sponsor's protocol ID
- 1204E
- Status last verified
- Feb 2021
- First submitted
- 4 Aug 2017
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perception, Cognition, and Gait in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03241966
- Acronym / sponsor ID
- 1204E
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's Disease, Online Study, Quality of Life, Activities of Daily Living, Perception, Cognition, Gait
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 439 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 15 Jan 2019 (actual)
- Study completion
- 15 Jan 2019 (actual)
- First posted
- 8 Aug 2017 (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 examining how aspects of daily function are perceived in persons with PD and in those who interact with them on a regular basis. If eligible, participants will receive a set of online questionnaires by email. The questionnaires will take about 1 hour to complete, and can be done at the participant's convenience. The investigators are looking for volunteers who have a diagnosis of Parkinson's disease without dementia (age 40 or older and proficient English speakers). If a spouse, family member, significant other or other close associate is available (age 18 or older, proficient English speakers), the investigators will send them questionnaires as well. There is no monetary or other compensation for this study. For more information, please contact the Vision and Cognition Laboratory at vcognition@gmail.com or 617-358-1377.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| People with Parkinson's Disease | – | –Individuals diagnosed with idiopathic Parkinson's disease without dementia. |
| Informant | – | –Family member, spouse, significant other, caregiver, or other close associate of someone with Parkinson's disease. |
Who may qualify
- Ages
- 40 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants are accepted regardless of location, community, clinic, etc.
Key inclusion criteria (5 listed)
- Diagnosed with Parkinson's disease without dementia OR close associate of someone with Parkinson's disease
- 40 years or older
- Proficient English speaker
- Access to a computer
- 8+ years of education
Key exclusion criteria (6 listed)
- Co-existing active neoplasm, serious cardiac disease, other serious chronic medical illness
- Prior intracranial surgery
- History of traumatic brain injury
- Psychiatric or neurological diagnoses other than Parkinson's disease
- History of alcoholism or other drug abuse
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
Parkinson's Disease Questionnaire (PDQ-39)
Time frame: Within 24 hours of starting the study
Measures the health status of Parkinson's disease patients and the impact the disease has on their aspects of daily living. There are 39 items.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
- Individual participant dataSharing planned: No
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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.
Alice Cronin-Golomb, Ph.D. principal investigator
Boston University
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 Parkinson Disease, run by Boston University Charles River Campus 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 11 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parkinson's Disease Questionnaire (PDQ-39) (time frame: Within 24 hours of starting the study). 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 11 Feb 2021.