DiSCERN: Advanced PD Therapy Candidacy and Evaluation System

Great Lakes NeuroTechnologies

Status: Active, not recruiting

Conditions: Parkinson Disease

Treatments: Device: DiSCERN

Study type: Observational

Funder types: Other; Industry; NIH

Identifiers

NCT05351580

5R44MD013767-03 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

To collect data to develop models that identify when patients with advanced Parkinson's disease (PD) are not responding well to their current therapy and may be ready to consider advanced therapy and when patients receiving advanced therapy are not responding well and need a therapy adjustment.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Able to provide informed consent
• Diagnosed with Parkinson's disease
• Current levodopa use
• Hoehn and Yahr scale II-III
• Ambulatory and capable of using the DiSCERN smartphone system
• Able to understand and follow instructions regarding using the device
• Half of participants (10 per site) identified as candidates for deep brain stimulation or drug pump by their treating neurologist, but before their surgeries take place.
• The remainder (10 per site) will be individuals with advanced PD as defined by having a UPDRS motor complications scores ≥ 4.

Exclusion criteria

• Any subject that does not meet the inclusion criteria will be excluded from this study. Subjects not capable of following the required clinical instruction for this study will be excluded. Potential subjects will be screened to ensure no cognitive impairments exist that would prohibit them from properly using the system. Exclusion criteria includes cognitive impairment as evidenced by a score less than 24 on the Montreal Cognitive Assessment (MoCA) UNLESS the subject has a caregiver able and willing to facilitate use of the DiSCERN system based on the judgement of the treating neurologist.

Trial design

60 participants in 2 patient groups

Advanced Parkinson's disease patients who receive advance therapy during the study

Description:

All participants will have advanced Parkinson's disease and undergo smart watch monitoring. Participants in this cohort will be those who receive advance therapy during the study.

Treatment:

Device: DiSCERN

Advanced Parkinson's disease patients who do not receive advance therapy during the study

Description:

All participants will have advanced Parkinson's disease and undergo smart watch monitoring. Participants in this cohort will be those who do not receive advance therapy during the study.

Treatment:

Device: DiSCERN