Objective, Passive Assessment of LRRK2 Carriers

Parkinson Disease Clinical Trial

— OPAL  

Official title:

Objective, Passive Assessment of LRRK2 Carriers

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05287620
• Other study ID #: STUDY00006771
• Status: Active, not recruiting
• Start date: April 27, 2022
• Est. completion date: May 31, 2024

Study information

• Verified date: September 2023
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 without needing to wear sensors, answer questionnaires, or actively perform any tests.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (3)

Lead Sponsor	Collaborator
University of Rochester	Emerald Innovations, Michael J. Fox Foundation for Parkinson's Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gait speed		1 year