Status:
COMPLETED
DiSCERN: Advanced PD Therapy Candidacy and Evaluation System
Lead Sponsor:
Great Lakes NeuroTechnologies Inc.
Collaborating Sponsors:
University of Cincinnati
The Cleveland Clinic
Conditions:
Parkinson Disease
Eligibility:
All Genders
18+ years
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 21 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2024
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT05351580
Start Date
July 21 2022
End Date
June 30 2024
Last Update
August 26 2025
Active Locations (2)
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1
University of Cincinnati
Cincinnati, Ohio, United States, 45219
2
Cleveland Clinic
Cleveland, Ohio, United States, 44195