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

NCT07389018 | Not Yet Recruiting

• 2 other identifiers: PR5030-762024-A02611-46
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Progressive Supranuclear Palsy- Richardson Syndrome (PSP-R)

Outcome Measures

Primary Outcomes (2)

• Number of patients reaching the optimal threshold of recordings during the recording periods defined in the protocol.

  Number of patients reaching the optimal threshold of recordings during the recording periods defined in the protocol (supposed optimal threshold for analysis) at baseline, Month 4, Month 8, Month 12 and Month 16.

  16 months

• French Usability score (F-SUS) at Month 4 and at the end of the study

  Usability score at Month 4 and Month 16. The System Usability Scale is a 10-item questionnaire . It is a simple tool to measure the usability of an interactive system and it is widely used. For each item, the user is asked to express their level of agreement or disagreement from 1 (strongly disagree) and 5 (strongly agree).

  16 months

Secondary Outcomes (10)

• Change from baseline in the total wearing time at months 4, 8, 12, and 16.

  16 months

• Reproducibility of Syde® digital endpoints for each recording period timepoint

  16 months

• Correlation between Syde® digital endpoints and 2-minute walk test (2MWT)

  16 months

• Correlation between Syde® digital endpoints and 10-meter walk test (10MWT)

  16 months

• Correlation between Syde® digital endpoints and Timed Up and Go (TUG)

  16 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients With Progressive Supranuclear Palsy - Richardson Syndrome (PSP-R)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• SYSNAV: lead

Study Sites (1)

Hôpital Fondation Adolphe de Rothschild

Paris, 75019, France

Location

Study Officials

• Jean-Philippe BRANDEL

  Hopital Fondation Adolphe de Rothschild

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ferial Toumi

CONTACT

+33 2 78 00 10 98; ferial.toumi@sysnav.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: February 5, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

FR (1)