DiSCERN: Advanced PD Therapy Candidacy and Evaluation System

Parkinson Disease Clinical Trial

— DiSCERN  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05351580
• Other study ID #: 5R44MD013767-03
• Secondary ID: 5R44MD013767-03
• Status: Active, not recruiting
• Start date: July 21, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: February 2024
• Source: Great Lakes NeuroTechnologies Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• DiSCERN
Smart watch Monitoring

Locations

Country	Name	City	State
United States	University of Cincinnati	Cincinnati	Ohio
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (5)

Lead Sponsor	Collaborator
Great Lakes NeuroTechnologies Inc.	National Institute on Minority Health and Health Disparities (NIMHD), Ohio State University, The Cleveland Clinic, University of Cincinnati

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom severities	Symptom severities measured by smart watch	Eight (8) months compared to baseline
Secondary	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
Secondary	Kinesia ONE motor assessment		Eight (8) months compared to baseline
Secondary	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
Secondary	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
Secondary	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