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ACTIVE NOT RECRUITING
NCT04985539

The Personalized Parkinson Project De Novo Cohort

Sponsor: Radboud University Medical Center

View on ClinicalTrials.gov

Summary

Currently, the Movement Disorders Society (MDS)-UPDRS scale remains the gold standard to document the outcomes in clinical trials for Parkinson's disease (PD). The MDS-UPDRS is far from infallible, as it is based on subjective scoring (using a rather crude ordinal score), while execution of the tests depends on clinical experience. Not surprisingly, the scale is subject to both significant intra- and inter-rater variability that are sufficiently large to mask an underlying true difference between an effective intervention and placebo. Digital biomarkers may be able to overcome the limitations of the MDS-UPDRS, as they continuously collects real-time data, during the patient's day to day activities. In this study the investigators are interested in developing algorithms to track progression of bradykinesia, gait impairment, postural sway, tremor, physical activity, sleep quality, and autonomic dysfunction (the latter being derived from e.g. skin conductance and changes in heart rate variability).

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

103

Start Date

2020-08-29

Completion Date

2025-12

Last Updated

2025-03-24

Healthy Volunteers

No

Interventions

DEVICE

Verily Study Watch

Participants wear the Verily Study Watch for 2 years, for longitudinal data collection.

Locations (1)

Radboud University Medical Center

Nijmegen, Netherlands