Objective, Passive Assessment of LRRK2 Carriers

NCT ID: NCT05287620

Last Updated: 2024-06-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-27
• Study Completion Date: 2024-05-07

Brief 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.

Conditions

Parkinson Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Emerald 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emerald Innovations

UNKNOWN

Sponsor Role: collaborator

Michael J. Fox Foundation for Parkinson's Research

OTHER

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Ray Dorsey

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ray Dorsey, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

University of Rochester

Rochester, New York, United States

Countries

United States

Other Identifiers

STUDY00006771

Identifier Type: -

Identifier Source: org_study_id