ClinicalTrials.gov record NCT07389018

Study to Evaluate the Feasibility of Syde® Digital Endpoints for Monitoring Patients With Progressive Supranuclear Palsy - Richardson Syndrome (PSP-R)

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

Prospective Longitudinal Monocentric Study to Evaluate the Feasibility of Syde® Digital Endpoints for Monitoring Patients With Progressive Supranuclear Palsy - Richardson Syndrome (PSP-R)

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.

Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.

Age18 years old and older

SexAll

LocationFrance

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This prospective observational study tests whether a wearable device (Syde®) can feasibly collect real‑world activity and gait data in people with Progressive Supranuclear Palsy–Richardson Syndrome (PSP‑R). Researchers will compare the device's digital measures with on-site clinical tests of walking, falls, functional and cognitive assessments, and PSP rating scales. Data collection occurs at baseline and at 4, 8, 12 and 16 months, with repeated home recording periods and usability questionnaires.

What it is studying. Whether Syde® wearable sensors are acceptable and feasible for home activity and gait monitoring in PSP‑R; whether the device's digital endpoints are reproducible over time and relate (correlate) to standard clinical measures such as walking tests, falls reports, PSP rating scales, and cognitive tests.

What the researchers hope to learn. Scientific aims: assess feasibility and acceptability of Syde® wearable monitoring in PSP‑R; evaluate reproducibility of digital endpoints; examine correlations between Syde® measures and clinical walking tests, falls, PSP rating scales, and cognitive assessments; and track longitudinal change in digital endpoints (including stride velocity SV95C).

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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.
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.
Absence of caregiver.

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants will wear Syde® sensors on their ankles during repeated 4‑week real‑world recording periods that occur every 4 months (baseline, 4, 8, 12, 16 months). They will receive training on device use, be asked to tolerate the sensors for the recording periods, and return the device at the end of the study. At scheduled on‑site visits participants will complete walking and functional tests, cognitive assessments, and eye‑movement recording (eye recordings every 8 months), and will fill usability questionnaires (System Usability Scale at month 4 and study end). The study team will track wearing time and compare the wearable data with the clinical tests.

How the study is structured. A prospective, single‑center observational cohort study. Participants will use Syde® sensors during repeated home recording periods (about 4 weeks every 4 months) over 16 months, attend on-site clinical assessments at set timepoints, and complete usability questionnaires.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
The registry says recruitment has not started. When is it expected to open, and can I register interest now?
The listed sites are in France. Is any of them reachable for me, and does the study help with travel?
Which of the eligibility criteria would need to be checked with tests before I could join?

More on progressive supranuclear palsy

Clinical trials45 trials listed for progressive supranuclear palsyEvery trial the registry lists for progressive supranuclear palsy, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in progressive supranuclear palsy researchLatest monthly update: September 2026. Includes: PSP vs Parkinsons. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: May 2026 (estimated)
Primary completion: March 2028 (estimated)
Study completion: March 2028 (estimated)
Target enrollment: 30 participants (estimated)
Last updated on registry: Apr 22, 2026
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: SYSNAV

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Ferial Toumi 📞 +33 2 78 00 10 98 ✉ ferial.toumi@sysnav.fr

Participating sites (1)

Hôpital Fondation Adolphe de Rothschild
Paris, 75019 · France

Terms used on this page · explanations by MedicalUpdates.ai

endpoints: Something the study measures to judge its results, such as a symptom score, a blood test or survival. Outcomes are grouped as primary, secondary and sometimes exploratory.
informed consent form: The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
Inclusion Criteria: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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