NCT05501431Completed
Personalized Parkinson Project PSP Cohort
Source: ClinicalTrials.gov · Last updated 24 Mar 2025
Brief summary (registry, in English)
There is an urgent need for the development of digital progression biomarkers, which are sensitive to detect small, but potentially clinically relevant changes in the disease course. Digital biomarkers are based on (i) continuously collected real-time data, during the patient's day to day activities; and (ii) task-based assessment. In this study the investigators are interested in developing algorithms for the detection of disease progression in PSP patients in key clinical parameters: bradykinesia, gait, rising from a chair and falls, based on (i) sensor data obtained by means of passive monitoring during daily living; and (ii) sensor data collected during the Virtual Motor Exam.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 100 (actual)
- First submitted
- 11 Aug 2022
- Start date
- 1 May 2021
- Primary completion date
- 14 Aug 2024
- Lead sponsor
- Radboud University Medical Center
- Diseases
- Parkinson disease
- NCT number
- NCT05501431
What you commit to
- Study type: Observational
- Participants enrolled: 100
- From 1 May 2021 to the primary completion date, 14 Aug 2024
- 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
- Subject has an additional condition or situation that, in the opinion of the Investigator, makes the subject inappropriate for participation in the study.
- For Study Watch: subject is allergic to nickel.
Who the study is looking for
- Subject has possible or probable PSP, according to the established international criteria defined by the Movement Disorders Society (MDS-PSP criteria, Höglinger et al, 2017); diagnosis is confirmed based on by consensus review process. In addition to the diagnosis of the own treating neurologist, the diagnosis always needs to be confirmed by at least one neurologist with deep expertise in movement disorders. The videotaped neurological examination as obtained during visit 1 will be used by the expert neurologist.
- Subject is an adult, at least 50 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.
- Subject is able to walk at least 5 steps with or without minimal assistance (ie, stabilization of 1 arm or use of a cane or walker).
- Subject has no neurological or musculoskeletal disorder or any other condition that impairs movement, gait, or balance, in the opinion of the Investigator.
- Subject is an adult, at least 50 years of age.
- Subject can read and understand Dutch.
- Subject has completed the Informed Consent, as approved by the IRB.
- Subject is willing, competent, and able to comply with all aspects of the protocol.
- Subject is able to walk at least 5 steps with or without minimal assistance (i.e., stabilization of 1 arm or use of a cane or walker).
Age in the registry: 50 years to - · Sex: All · Accepts 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.