Parkinson DiseaseOPALNCT05287620
Objective, Passive Assessment of LRRK2 Carriers
An observational study of Parkinson Disease, run by University of Rochester at 1 site in United States.
Trial summary
The goal of this project is to identify objective, sensitive, and convenient measures for assessing early signs of Parkinson's disease in an at-risk population at home. We will do so by using a wireless sensor and analyzing the radio signals that bounce off patients' bodies, while patients go about their normal life… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Emerald device
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2022to 7 May 2024
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We will enroll LRRK2 G2019S carriers without self-reported or clinician-determined Parkinson's disease (PD) from the VALOR-PD study. VALOR-PD is an observational study following and characterizing a remote, nationwide cohort of LRRK2 G2019S carriers with (n = 59) and without PD (n = 218). Individuals who have a diagnosis of PD will not be eligible to participate, since we aim to explore the device's sensitivity in detecting early symptoms/signs of PD.
Who may be able to join
- At least 50 years of age
- Able and willing to provide informed consent
- English fluency
- U.S. resident
- LRRK2 G2019S gene carrier, determined by participation in VALOR-PD
- Mild parkinsonian signs, determined by modified Movement Disorder Society-Unifeid Parkinson's Disease Rating Scale (MDS-UPDRS) score from the most recent VALOR-PD visit
- Have WiFi in their residence
- Access to a smartphone or tablet
Who cannot join
- Inability to complete study activities, as determined by the study team
- Any medical or psychiatric condition that, in the study team's judgement, would preclude participation
- Self-reported or VALOR-PD investigator determined Parkinson's disease
- Any movement disorder (e.g. essential tremor)
- Currently taking neuroleptics or other drugs known to cause parkinsonism
- Pregnancy
Show all 10Show fewer
- Non-ambulatory status
- More than one ambulatory pet in the household*
- More than two individuals in the household (not including participant)*
- these criteria can be waived at the discretion of the investigators
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this project is to identify objective, sensitive, and convenient measures for assessing early signs of Parkinson's disease in an at-risk population at home. We will do so by using a wireless sensor and analyzing the radio signals that bounce off patients' bodies, while patients go about their normal life without needing to wear sensors, answer questionnaires, or actively perform any tests.
- Conditions
- Parkinson Disease
- Being tested
- Emerald device
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emerald deviceDevice
The Emerald device is a wireless sensor that can track the motion, breathing, and sleep of participants without touching or requiring any interaction with the participants, allowing them to go about their normal lives. The Emerald device operates by transmitting and receiving low power radio signals that reflect off of the participant and return back to the device. The power of these signals is 1,000 times lower than what a typical Wi-Fi device transmits. The ability of the device to monitor gait, breathing, sleep, and other metrics has been validated and documented. Studies of the Emerald device in individuals with Parkinson's disease, Alzheimer's disease, and rare diseases have demonstrated the feasibility of monitoring at home and the ability to characterize gait, breathing, and sleep in these populations specifically. In this study, the Emerald device will be used to characterize the mobility, breathing and sleep of the participant.
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait speed
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 posted18 Mar 2022
- Study start27 Apr 2022
- Primary completion7 May 2024
- Study completion7 May 2024
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.
- More trials run by University of RochesterThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Emerald Innovations, Michael J. Fox Foundation for Parkinson's Research
- Responsible party
- Principal investigator, Ray Dorsey, University of Rochester
- Investigators
- Ray Dorsey, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05287620
- Sponsor's protocol ID
- STUDY00006771
- Acronym
- OPAL
- Status last verified
- Jun 2024
- First submitted
- 9 Mar 2022
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective, Passive Assessment of LRRK2 Carriers
- ClinicalTrials.gov ID
- NCT05287620
- Acronym / sponsor ID
- OPAL / STUDY00006771
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Emerald Innovations, Michael J. Fox Foundation for Parkinson's Research
- Study start
- 27 Apr 2022 (actual)
- Primary completion
- 7 May 2024 (actual)
- Study completion
- 7 May 2024 (actual)
- First posted
- 18 Mar 2022 (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 goal of this project is to identify objective, sensitive, and convenient measures for assessing early signs of Parkinson's disease in an at-risk population at home. We will do so by using a wireless sensor and analyzing the radio signals that bounce off patients' bodies, while patients go about their normal life without needing to wear sensors, answer questionnaires, or actively perform any tests.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We will enroll LRRK2 G2019S carriers without self-reported or clinician-determined Parkinson's disease (PD) from the VALOR-PD study. VALOR-PD is an observational study following and characterizing a remote, nationwide cohort of LRRK2 G2019S carriers with (n = 59) and without PD (n = 218). Individuals who have a diagnosis of PD will not be eligible to participate, since we aim to explore the device's sensitivity in detecting early symptoms/signs of PD.
Key inclusion criteria (8 listed)
- At least 50 years of age
- Able and willing to provide informed consent
- English fluency
- U.S. resident
- LRRK2 G2019S gene carrier, determined by participation in VALOR-PD
Key exclusion criteria (10 listed)
- Inability to complete study activities, as determined by the study team
- Any medical or psychiatric condition that, in the study team's judgement, would preclude participation
- Self-reported or VALOR-PD investigator determined Parkinson's disease
- Any movement disorder (e.g. essential tremor)
- Currently taking neuroleptics or other drugs known to cause parkinsonism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emerald deviceThe Emerald device is a wireless sensor that can track the motion, breathing, and sleep of participants without touching or requiring any interaction with the participants, allowing them to go about their normal lives. The Emerald device operates by transmitting and receiving low power radio signals that reflect off of the participant and return back to the device. The power of these signals is 1,000 times lower than what a typical Wi-Fi device transmits. The ability of the device to monitor gait, breathing, sleep, and other metrics has been validated and documented. Studies of the Emerald device in individuals with Parkinson's disease, Alzheimer's disease, and rare diseases have demonstrated the feasibility of monitoring at home and the ability to characterize gait, breathing, and sleep in these populations specifically. In this study, the Emerald device will be used to characterize the mobility, breathing and sleep of the participant. | Device | – |
Primary outcome
Gait speed
Time frame: 1 year
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 28 Jun 2024.
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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.
Ray Dorsey, MD principal investigator
University of Rochester
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 University of Rochester 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 8 inclusion and 10 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 28 Jun 2024. 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?
Gait speed (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 28 Jun 2024.