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The Personalized Parkinson Project De Novo Cohort

NCT04985539 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 103

Last updated 2025-03-24

No results posted yet for this study

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).

Conditions

Interventions

DEVICE

Verily Study Watch

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

Sponsors & Collaborators

  • UCB Pharma

    collaborator INDUSTRY

  • Verily Life Sciences LLC

    collaborator INDUSTRY

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Bastiaan R Bloem, MD, PhD · Radboud University Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-29
Primary Completion
2025-11-30
Completion
2025-12-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04985539 on ClinicalTrials.gov