Clinical trial NCT05351580: DiSCERN: Advanced PD Therapy Candidacy and Evaluation System
Official title: DiSCERN: Advanced PD Therapy Candidacy and Evaluation System - Advanced PD Data Collection
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Parkinson Disease
Keywords: Dyskinesia
Parkinson's Disease
Deep brain stimulation
Wearable
Lead sponsor: Great Lakes NeuroTechnologies Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Cincinnati
name: The Cleveland Clinic
name: National Institute on Minority Health and Health Disparities (NIMHD)
name: Ohio State University
First posted: 2022-04-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Our three clinical sites will recruit a total of 60 individuals diagnosed with advanced PD who regularly take levodopa. At least half the subjects will have already been identified as candidates for DBS or LCIG, but before their surgeries take place. The remainder will be non-demented (MoCA \> 24) advanced PD patients as defined by having a UPDRS motor complications scores ≥ 4. All participants must be ambulatory and capable of using the smartphone-based DiSCERN system either independently or with the help of a caregiver.

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 when patients receiving advanced therapy are not responding well and need a therapy adjustment.


Eligibility criteria: 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.

Primary outcomes:
measure: Symptom severities
timeFrame: Eight (8) months compared to baseline
Secondary outcomes:
measure: Unified Parkinson's Disease Rating Scale (UPDRS) Part III
timeFrame: Eight (8) months compared to baseline
measure: Kinesia ONE motor assessment
timeFrame: Eight (8) months compared to baseline
measure: Parkinson's Disease Questionnaire (PDQ-39)
timeFrame: Eight (8) months compared to baseline
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Eight (8) months compared to baseline
measure: MANAGE-PD questionnaire
timeFrame: Eight (8) months compared to baseline
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: Great Lakes NeuroTechnologies Inc.
name: Dustin A Heldman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Heldman DA, Giuffrida JP, Cubo E. Wearable Sensors for Advanced Therapy Referral in Parkinson's Disease. J Parkinsons Dis. 2016 Jul 2;6(3):631-8. doi: 10.3233/JPD-160830.