Development of Digital Services for Parkinson's Disease
NCT06733077 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2025-02-03
Summary
In this project, ocular motor, pupil and gait data in people with Parkinson's disease (PD) will be collected in order to develop machine learning models for the diagnosis and monitoring of PD. With this, the investigators aim to advance the state of the art in PD diagnosis and monitoring. By integrating the principles of machine learning with high-quality sensor data, more accurate and earlier diagnosis could potentially be achieved. Ocular motor and pupil data will be collected with the standard clinical examination and with neos, a medical device approved for objective ocular motor and pupil measurement. Gait will be collected using an IMU sensor and GaitQ senti, a consumer device that allows for an objective and continuous remote gait monitoring.
Conditions
- Healthy Controls
- Parkinson's Disease
Interventions
- DEVICE
-
gait with cueing wearable device and neuro-ocular performance
Participants will be invited to participate in the following sequential phases. Participants can participate in Phases as selected. Control participants will not be invited to Phase 4. Phase 1. Lab testing \[2 hours\] Validation study of digital technology measures MachineMD and gaitQ to criterion metric of UPDRS. Phase 2. home/community testing \[2 weeks daily\] Determine feasibility of daily measuring in the home of gaitQ to determine usability, acceptability, and day to day variability of measurement metrics and to determine concurrent validation of home metric to lab metrics to determine, reliability, concurrent validity of change, minimal detectable change and criterion validation to lab-based measures. Phase 3. Lab retesting \[2 hours\] see Phase 1 Phase 4. Home/community intervention \[2 weeks\] Determine the potential for effect of the gaitQ vibration intervention from a 2-week exposure in the home.
Sponsors & Collaborators
-
University of Zurich
collaborator OTHER -
University Hospital, Zürich
collaborator OTHER -
machineMD AG
collaborator INDUSTRY -
GaitQ company
collaborator UNKNOWN -
University of Exeter
lead OTHER
Principal Investigators
-
Helen Dawes, PhD · University of Exeter
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-12-20
- Primary Completion
- 2026-04-01
- Completion
- 2026-04-01
Countries
- United Kingdom
Study Locations
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