Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT06733077

Development of Digital Services for Parkinson's Disease

Sponsor: University of Exeter

View on ClinicalTrials.gov

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.

Official title: Development of Digital Diagnostics and Intervention Services for Parkinson's Disease

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-12-20

Completion Date

2026-04-01

Last Updated

2025-02-03

Healthy Volunteers

Yes

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.

Inclusion criteria Participants with Parkinson's \[Phase 1,2,3,4\] * Diagnosis of idiopathic Parkinson's disease (UK Brain Bank Criteria) or other appropriate condition specific scale \[stroke, multiple sclerosis, arthritis or osteoporosis\] * Able to self-report history of daily gait freezing and/or festination for people with PD or gait and/or transfers affected by condition * Able to walk unsupported or using an aid for at least 5 minutes and satisfactory completion of the Canadian PARQ and if over 69 used to carrying out this level of exercise * Adult (+18 years old) * Normal or corrected-to-normal vision (Snellen Visual Acuity \> 12/18) or safe to mobilise with support * Montreal Cognitive assessment score \>21 or ability to follow 2 stage commands Healthy participants \[Phase 1,2,3\] * With no long-term conditions affecting movement * Able to walk unsupported or using an aid for at least 3 minutes and satisfactory completion of the Canadian PARQ and if over 69 used to carrying out this level of exercise * Adult (+18 years old) * Normal or corrected-to-normal vision (Snellen Visual Acuity \> 12/18) or safe to mobilise with support * Montreal Cognitive assessment score \>21 or ability to follow 2 stage commands Exclusion criteria Participants with Parkinson's * Any physical or mental condition affecting ability to safely participate in this level of activity and capacity to understand testing as demonstrated by ability to safely follow commands and pass the PARQ by the research team. * Cognitive impairment affecting ability to safely participate and follow instructions * Any injury or disorder that may affect balance (other than Parkinson's or referring primary condition) * Any skin conditions or broken skin in the calf and behind knee area * Deep brain stimulation or pacemaker implants or other implant that may interfere with the measurement system * Medications likely to affect eye sight or use of virtual reality sytstem Healthy participants * Any physical or mental condition affecting ability to safely participate in this level of activity and capacity to understand testing as demonstrated by ability to safely follow commands and pass the PARQ by the research team. * Cognitive impairment affecting ability to safely participate and follow instructions * Any injury or disorder that may affect balance (other than Parkinson's or referring primary condition) * Any skin conditions or broken skin in the calf and behind knee area * Deep brain stimulation or pacemaker implants or other implants that may interfere with the measurement system

Locations (1)

University of Exeter

Exeter, United Kingdom