Objective, Passive Assessment of LRRK2 Carriers

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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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Rochester

Rochester, New York, 14620, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Emerald device

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.

Primary outcomes

Gait speed

Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

Emerald Innovations
Michael J. Fox Foundation for Parkinson's Research

Registry information

Acronym: OPAL

Important dates

Study start: 2022
Primary completion: 2024
Study completion: 2024
First posted: Mar 18, 2022
Registry last updated: Jun 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed