Parkinson Disease
Conditions
Keywords
Dyskinesia, Parkinson's Disease, Deep brain stimulation, Wearable
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.
Interventions
DEVICEDiSCERN
Smart watch Monitoring
Sponsors
University of Cincinnati
The Cleveland Clinic
National Institute on Minority Health and Health Disparities (NIMHD)
Ohio State University
Great Lakes NeuroTechnologies Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptom severities | Eight (8) months compared to baseline | Symptom severities measured by smart watch |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Kinesia ONE motor assessment | Eight (8) months compared to baseline | — |
| 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. |
| 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. |
Countries
United States
Outcome results
None listed