Study to Evaluate the Feasibility of Syde® Digital Endpoints for Monitoring Patients With Progres… (NCT07389018) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Study to Evaluate the Feasibility of Syde® Digital Endpoints for Monitoring Patients With Progressive Supranuclear Palsy - Richardson Syndrome (PSP-R)
France30 participantsStarted 2026-05
Plain-language summary
The study aims to assess the feasibility/acceptability of real-world activity monitoring by the Syde® wearable device in PSP-R. The Syde® collected data will be compared to on-site conventional clinical endpoints, including functional capacity and cognitive assessments, as well as core scales assessments.
Who can participate
Age range
18 Years
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
.18 years old or older
.Participants affiliated to, or beneficiary from, a social security.
.Ambulant patients (i.e. able to walk 10 meters without assistance)
.Signed informed consent form by the patient himself or, by caregivers if the patient is not capable to fill, date and sign the form due to fine motor function difficulties..
.Possible or probable PSP-R according to MDS criteria 2017(Hoglinger et al., Mov Disorder, 2017).
Exclusion criteria
. Patients with extreme cognitive disorders that limit their understanding of the data collection process (training of device use and 4-week recording periods every 4 months, device return at the end of the study), tests to be performed including eye movement recording (every 8 months), the implication of the study and consent.
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
Number of patients reaching the optimal threshold of recordings during the recording periods defined in the protocol.
Timeframe: 16 months
2
French Usability score (F-SUS) at Month 4 and at the end of the study
. Patients who do not tolerate to keep the sensors on their ankles.
. Patients who have undergone a surgical procedure or who have experienced recent trauma (within fewer than 6 months) affecting the lower limbs.
. A concomitant chronic or acute neurological, endocrine, infectious, allergic, or inflammatory pathology within the 3-week period immediately prior to inclusion.
. Patients affected by any other disorder having a significant impact on gait or lower limb function.
. Participant covered by a legal protection measure (guardianship, curatorship or safeguarding of justice) or who is unable to express their consent.