DiSCERN: Advanced PD Therapy Candidacy and Evaluation System (DiSCERN)

DiSCERN: Advanced PD Therapy Candidacy and Evaluation System - Advanced PD Data Collection

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Device: DiSCERN

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Autumn Cox; Phone Number: 2163615410; Email: support@glneurotech.com

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Smart watch Monitoring
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; Smart watch Monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptom severities	Symptom severities measured by smart watch	Eight (8) months compared to baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unified Parkinson's Disease Rating Scale (UPDRS) Part III	UPDRS Part III has 33 items assessing motor skills including facial expression and speech, tremors, rigidity, posture, gait, and bradykinesia. Each of the 33 items in the UPDRS part III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities. The motor score ranges from 0 to 132, where the maximum score indicates the worse condition. A negative value in change indicates improvement, whereas a positive value indicates worsening of disease.	Eight (8) months compared to baseline
Kinesia ONE motor assessment		Eight (8) months compared to baseline
Parkinson's Disease Questionnaire (PDQ-39)	The PD Quality of Life Questionnaire-39 (PDQ-39) is a self-report questionnaire that examines health related difficulties specific to PD in eight quality of life categories within the last month. Items are grouped into eight scales that are scored by expressing summed item scores as a percentage score ranging between 0 and 100, with higher % indicating more health problems.	Eight (8) months compared to baseline
Montreal Cognitive Assessment (MoCA)	The MoCA consists of 30 test items that assess visuospatial and executive functioning, naming, memory, attention, language, abstraction, delayed recall, and orientation. Each correct answer is awarded one point, which are added to create a total score. A higher score is a better outcome and indicates less cognitive impairment.	Eight (8) months compared to baseline
MANAGE-PD questionnaire	MANAGE-PD is designed to support healthcare providers in the identification of patients with Parkinson's Disease uncontrolled on oral medications. The questionnaire consists of two sections and should be answered based on symptoms during the last month. Patients are categorized into three categories based on responses: Category 1: Patient may be controlled on the current treatment regimen. Category 2: Patient may not be controlled on the current treatment regimen. Category 3: Patient may not be controlled on the current treatment regimen and may benefit from device-aided therapy.	Eight (8) months compared to baseline

Collaborators and Investigators

• Sponsor: Great Lakes NeuroTechnologies Inc.
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD); The Cleveland Clinic; Ohio State University; University of Cincinnati
• Investigators: Principal Investigator: Dustin A Heldman, PhD, Great Lakes NeuroTechnologies Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2022
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: April 15, 2022
• First Submitted That Met QC Criteria: April 25, 2022
• First Posted (Actual): April 28, 2022

Study Record Updates

• Last Update Posted (Actual): February 2, 2024
• Last Update Submitted That Met QC Criteria: February 1, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Parkinson's Disease; Deep brain stimulation; Dyskinesia; Wearable
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 5R44MD013767-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes