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CompletedNCT05287620OPALUpdated Jun 28, 2024

Objective, Passive Assessment of LRRK2 Carriers

An observational study in Parkinson Disease, sponsored by University of Rochester. Completed at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2024-06-28.

Sponsored by University of Rochester · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10
Ages
50 Years and older
Sex
All
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Study 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 without needing to wear sensors, answer questionnaires, or actively perform any tests.

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Conditions studied

  • Parkinson Disease

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03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's enrollment of 10 is below the median of 96 across 1,057 observational studies indexed under Parkinson Disease.

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Lead sponsor

University of Rochester is the lead sponsor of 715 studies on the registry; 116 are open to participants now.

Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10 participants (actual)
Patient registry
No

Interventions

  • DeviceEmerald device

    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.

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What researchers measure

Primary outcomes

  1. Gait speed

    Time frame: 1 year

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Study locations

1 site
  • University of Rochester
    Rochester, New York 14620, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05287620
Lead sponsor
University of Rochester
Collaborators
Emerald Innovations, Michael J. Fox Foundation for Parkinson's Research
Responsible party
Ray Dorsey (Professor, University of Rochester) — Principal investigator
First posted
Mar 18, 2022
Start date
Apr 27, 2022
Primary completion
May 7, 2024
Completion
May 7, 2024
Last update
Jun 28, 2024

Study contacts

Ray Dorsey, MD
principal investigator · University of Rochester

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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