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Completed

NCT Number: NCT05351580

DiSCERN: Advanced PD Therapy Candidacy and Evaluation System

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Cincinnati, Cincinnati, Ohio, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DiSCERN

Device

Smart watch Monitoring

Primary outcomes

  1. Symptom severities

    Time frame: Eight (8) months compared to baseline

    Symptom severities measured by smart watch

Secondary outcomes

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

    Time frame: Eight (8) months compared to baseline

    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.

  2. Kinesia ONE motor assessment

    Time frame: Eight (8) months compared to baseline

  3. Parkinson's Disease Questionnaire (PDQ-39)

    Time frame: Eight (8) months compared to baseline

    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.

  4. Montreal Cognitive Assessment (MoCA)

    Time frame: Eight (8) months compared to baseline

    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.

  5. MANAGE-PD questionnaire

    Time frame: Eight (8) months compared to baseline

    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.

Sponsors and collaborators

Lead sponsor

Great Lakes NeuroTechnologies Inc.

Industry

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)
  • Ohio State University
  • The Cleveland Clinic
  • University of Cincinnati

Registry information

Official study title

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

Acronym: DiSCERN

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 28, 2022
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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