NCT04985539Active, not recruiting
The Personalized Parkinson Project De Novo Cohort
Source: ClinicalTrials.gov · Last updated 24 Mar 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 103 (actual)
- First submitted
- 22 Jul 2021
- Start date
- 29 Aug 2020
- Primary completion date
- Nov 2025
- Lead sponsor
- Radboud University Medical Center
- Diseases
- Parkinson disease
- NCT number
- NCT04985539
What you commit to
- Study type: Observational
- Participants enrolled: 103
- From 29 Aug 2020 to the primary completion date, Nov 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- For Study Watch: subject is allergic to nickel.
Other
- Subject has co-morbidities that would hamper interpretation of parkinsonian disability, such as coincident musculoskeletal abnormalities, in the opinion of the Investigator.
- Subject is taking Mucuna Pruriens.
Who the study is looking for
- Subject has Parkinson's disease of ≤2 years of duration, defined as the time since the diagnosis was made by a neurologist.
- Subject is an adult, at least 18 years of age.
- Subject can read and understand Dutch.
- Subject has completed the Informed Consent, as approved by the Institutional Review Board (IRB).
- Subject is willing, competent, and able to comply with all aspects of the protocol, including follow-up schedule and bio-specimen collection.
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Radboud University Medical Center Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.