Development of Digital Diagnostic Devices for Parkinson's Disease (NCT06663826) | Clinical Trial Compass
RecruitingNot Applicable
Development of Digital Diagnostic Devices for Parkinson's Disease
Switzerland100 participantsStarted 2024-10-01
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of Parkinson's disease or of another parkinsonian syndrome (atypical Parkinson's)
* Refractive error between -6 and +4 diopters, on both eyes
* Informed consent by participant documented per signature
* Able to self-report history of daily gait freezing and/or festination
* Able to walk unsupported or using an aid for at least 5 minutes and if over 69 used to carrying out this level of exercise
Exclusion Criteria:
* Other known neurological diseases
* Current medication/drugs that could potentially influence performance in ocular motor tasks and/or compliance in the judgement of the investigator (e.g. benzodiazepines, alcohol, stimulants, or recreational drugs) - except Parkinson's medications
* Incapacity to understand and comply with the examination (e.g. due to advanced cognitive decline, failure to comply with easy experimental instructions and tasks)
* Any injury or disorder that may affect eye movement measurements or balance (other than Parkinson's or referring primary condition)
* Any skin conditions or broken skin in the calf and behind the knee area
* Lack of access or limited connectivity to WiFi in home setting
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Development of machine learning models for diagnosing and monitoring of PD