Parkinson's Disease
Conditions
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Prior to enrollment in this clinical investigation, candidates must meet ALL of the following criteria: * Subject has never been treated before with any symptomatic dopaminergic drug treatment for Parkinson*s disease and is not expected to start treatment for motor symptoms of PD within 52 weeks from baseline. * Subject has Parkinson*s disease of
Exclusion criteria
Exclusion criteria: Candidates must be excluded from this study if ANY of the following criteria are met: * Subject is pregnant or breastfeeding. * Subject has co-morbidities that would hamper interpretation of parkinsonian disability, such as coincident musculoskeletal abnormalities, in the opinion of the lnvestigator. * Subject is allergic to nickel.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Digitale biomarkers, calculated from the Verily Study Watch data, i.e., . Pulse rate . Skin temperature, Electrodermal activity (sweat) . Movement data (Accelerometer) . Electrocardiogram (ECG) . Altitude, pressure, relative humidity . Environment temperature . Ambient light level . Sound pressure level The development of these digital biomarkers is part of the study. Selection of the digital biomarker is based on it's sensitivity to detect disease progression. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinimetrics (on site, by assessor) - Motor Assessment Subset ON Medication: Hoehn & Yahr stage; UPDRS-Il; UPDRS-Ill (lncluding timed up-and-go tests to assess gait); UPDRS-lV; Freezing of Gait Questionnaire; Standing leg /flamingo Test; Pirouette Test; Pegboard Test; Grip strength. - Neuropsychological Symptoms: UPDRS-I; Montreal Cognitive Assessment; Phonemic Fluency Semantic Fluency; 15 Words Test; Benton Judgment of Line Orientation; Letter Number Sequencing; Symbol Digit Modalities Test. Questionaires: - Neuropsychological symptoms: Beck Depression lnventoryi Quip- RS (impulsivecompulsive disorder); Apathy scale; Trait Anxiety lnventory for Adults; - Other UPDRS-ll;: SCOPA- autonomic; SCOPA- sleep; RBD questionnaire; Epworth sleep questionnaire; SF-12; PDQ-39; Wearing-off questionnaire; Radboud Oral Motor lnventory; Screening Questionnaire on Visual lmpairment; PASE (Physical Activity Scale for the Elderly). Biomarkers * lmaging - ECG: heart rate variability * Biospecimens - Blood: Plasma / PBMCs serum, EDTA plasma (DNA), PAXgene (RNA) | — |
Countries
Netherlands
Contacts
Public ContactMJ Meinders
Radboud Universitair Medisch Centrum
Outcome results
None listed