DiSCERN: Advanced PD Therapy Candidacy and Evaluation System

NCT05351580 | Completed

• 1 other identifier: 5R44MD013767-03
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 2

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.

Conditions

Parkinson Disease

Keywords

Dyskinesia; Parkinson's Disease; Deep brain stimulation; Wearable

Outcome Measures

Primary Outcomes (1)

• Symptom severities

  Symptom severities measured by smart watch

  Eight (8) months compared to baseline

Secondary Outcomes (5)

• Unified Parkinson's Disease Rating Scale (UPDRS) Part III

  Eight (8) months compared to baseline

• Kinesia ONE motor assessment

  Eight (8) months compared to baseline

• Parkinson's Disease Questionnaire (PDQ-39)

  Eight (8) months compared to baseline

• Montreal Cognitive Assessment (MoCA)

  Eight (8) months compared to baseline

• MANAGE-PD questionnaire

  Eight (8) months compared to baseline

Study Arms (2)

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

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.

Device: DiSCERN

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

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.

Device: DiSCERN

Interventions

DiSCERN DEVICE

Smart watch Monitoring

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• Great Lakes NeuroTechnologies Inc.: lead
• University of Cincinnati: collaborator
• The Cleveland Clinic: collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator
• Ohio State University: collaborator

Study Sites (2)

University of Cincinnati

Cincinnati, Ohio, 45219, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• 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.

  PMID: 27392872 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Dyskinesias

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dustin A Heldman, PhD

  Great Lakes NeuroTechnologies Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 15, 2022
• First Posted: April 28, 2022
• Study Start: July 21, 2022
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)