DiSCERN: Advanced PD Therapy Candidacy and Evaluation System

Active, not recruiting

• Conditions: Parkinson Disease

• Registration Number: NCT05351580
• Lead Sponsor: Great Lakes NeuroTechnologies Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-15
• Study First Submitted QC: 2022-04-25
• Study First Posted: 2022-04-28
• Study Start: 2022-07-21
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-01
• Last Update Posted: 2024-02-02
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Symptom severities	Eight (8) months compared to baseline	Symptom severities measured by smart watch

Secondary Outcome Measures

Name	Time	Method
Unified Parkinson's Disease Rating Scale (UPDRS) Part III	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.
MANAGE-PD questionnaire	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.
Parkinson's Disease Questionnaire (PDQ-39)	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.
Montreal Cognitive Assessment (MoCA)	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.
Kinesia ONE motor assessment	Eight (8) months compared to baseline

Trial Locations

Locations (2)

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States