An observational study in Parkinson Disease, sponsored by Great Lakes NeuroTechnologies Inc.. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-26.
Sponsored by Great Lakes NeuroTechnologies Inc. · Observational
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.
4,488 studies on the registry are indexed under Parkinson Disease; 1,083 are open to participants now.
This study's enrollment of 26 is below the median of 96 across 1,057 observational studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Great Lakes NeuroTechnologies Inc. is the lead sponsor of 19 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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
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
Symptom severities
Symptom severities measured by smart watch
Time frame: Eight (8) months compared to baseline
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.
Time frame: Eight (8) months compared to baseline
Kinesia ONE motor assessment
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Eight (8) months compared to baseline
Plan to share: No
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Great Lakes NeuroTechnologies Inc.