Progressive Supranuclear Palsy- Richardson Syndrome (PSP-R)PROSPER-SYDENCT07389018
Study to Evaluate the Feasibility of Syde® Digital Endpoints for Monitoring Patients With Progressive Supranuclear Palsy - Richardson Syndrome (PSP-R)
An observational study of Progressive Supranuclear Palsy- Richardson Syndrome (PSP-R), run by SYSNAV at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Progressive Supranuclear Palsy- Richardson Syndrome (PSP-R)
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- May 2026to Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients With Progressive Supranuclear Palsy - Richardson Syndrome (PSP-R)
Who may be able to join
- 1.18 years old or older
- 2.Participants affiliated to, or beneficiary from, a social security.
- 3.Ambulant patients (i.e. able to walk 10 meters without assistance)
- 4.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..
- 5.Possible or probable PSP-R according to MDS criteria 2017(Hoglinger et al., Mov Disorder, 2017).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prospective Longitudinal Monocentric Study to Evaluate the Feasibility of Syde® Digital Endpoints for Monitoring Patients With Progressive Supranuclear Palsy - Richardson Syndrome (PSP-R)
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 16 months
Secondary outcomes (10)
Change from baseline in the total wearing time at months 4, 8, 12, and 16.
Change from baseline in the total wearing time at months 4, 8, 12, and 16.
Measured: 16 months
Reproducibility of Syde® digital endpoints for each recording period timepoint
Reproducibility of Syde® digital endpoints assessed by the ICC (Intra-Class Correlation) and Bland and Altman analysis for each recording period timepoint (baseline, 4 months, 8 months, 12 months, and 16 months)
Measured: 16 months
Correlation between Syde® digital endpoints and 2-minute walk test (2MWT)
Correlation at baseline and at different timepoints between Syde® digital endpoints and 2MWT
Measured: 16 months
Correlation between Syde® digital endpoints and 10-meter walk test (10MWT)
Correlation at baseline and at different timepoints between Syde® digital endpoints and 10MWT
Measured: 16 months
Correlation between Syde® digital endpoints and Timed Up and Go (TUG)
Correlation at baseline and at different timepoints between Syde® digital endpoints and TUG
Measured: 16 months
Correlation between Syde® digital endpoints and falls reported by the participants
Correlation at baseline and at different timepoints between Syde® digital endpoints and falls reported by the participants
Measured: 16 months
Correlation between Syde® digital endpoints and Progressive Supranuclear Palsy Rating Scale (PSP-RS)
Correlation at baseline and at different timepoints between Syde® digital endpoints and PSP-RS
Measured: 16 months
Correlation between Syde® digital endpoints and Progressive Supranuclear Palsy Clinical Deficits Scale (PSP-CDS)
Correlation at baseline and at different timepoints between Syde® digital endpoints and PSP-CDS
Measured: 16 months
Correlation between Syde® digital endpoints and Montreal Cognitive Assessment (MoCA)
Correlation at baseline and at different timepoints between Syde® digital endpoints and MoCA
Measured: 16 months
Longitudinal change in Syde® digital endpoints. The Syde® digital endpoints will include the SV95C (Stride Velocity 95th centile)
Change from baseline in Syde® digital endpoints at 4, 8, 12 and 16 months. The Syde® digital endpoints will include the SV95C (Stride Velocity 95th centile)
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study startMay 2026 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progressive Supranuclear Palsy- Richardson Syndrome (PSP-R)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SYSNAV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean-Philippe BRANDEL, Principal investigator, Hopital Fondation Adolphe de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07389018
- Sponsor's protocol ID
- PR5030-76
- Other IDs
- 2024-A02611-46
- Acronym
- PROSPER-SYDE
- Status last verified
- Apr 2026
- First submitted
- 28 Jan 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Longitudinal Monocentric Study to Evaluate the Feasibility of Syde® Digital Endpoints for Monitoring Patients With Progressive Supranuclear Palsy - Richardson Syndrome (PSP-R)
- ClinicalTrials.gov ID
- NCT07389018
- Acronym / sponsor ID
- PROSPER-SYDE / PR5030-76
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- SYSNAVIndustry (pharma, biotech, devices)
- Study start
- May 2026 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 5 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients With Progressive Supranuclear Palsy - Richardson Syndrome (PSP-R)
Key inclusion criteria (5 listed)
- 1.18 years old or older
- 2.Participants affiliated to, or beneficiary from, a social security.
- 3.Ambulant patients (i.e. able to walk 10 meters without assistance)
- 4.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..
- 5.Possible or probable PSP-R according to MDS criteria 2017(Hoglinger et al., Mov Disorder, 2017).
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients reaching the optimal threshold of recordings during the recording periods defined in the protocol.
Time frame: 16 months
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.
French Usability score (F-SUS) at Month 4 and at the end of the study
Time frame: 16 months
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).
10 secondary outcomes
Change from baseline in the total wearing time at months 4, 8, 12, and 16.
Time frame: 16 months
Reproducibility of Syde® digital endpoints for each recording period timepoint
Time frame: 16 months
Correlation between Syde® digital endpoints and 2-minute walk test (2MWT)
Time frame: 16 months
Correlation between Syde® digital endpoints and 10-meter walk test (10MWT)
Time frame: 16 months
Correlation between Syde® digital endpoints and Timed Up and Go (TUG)
Time frame: 16 months
Correlation between Syde® digital endpoints and falls reported by the participants
Time frame: 16 months
Correlation between Syde® digital endpoints and Progressive Supranuclear Palsy Rating Scale (PSP-RS)
Time frame: 16 months
Correlation between Syde® digital endpoints and Progressive Supranuclear Palsy Clinical Deficits Scale (PSP-CDS)
Time frame: 16 months
Correlation between Syde® digital endpoints and Montreal Cognitive Assessment (MoCA)
Time frame: 16 months
Longitudinal change in Syde® digital endpoints. The Syde® digital endpoints will include the SV95C (Stride Velocity 95th centile)
Time frame: 16 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jean-Philippe BRANDEL principal investigator
Hopital Fondation Adolphe de Rothschild
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Progressive Supranuclear Palsy- Richardson Syndrome (PSP-R), run by SYSNAV at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ferial Toumi (+33 2 78 00 10 98, ferial.toumi@sysnav.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients reaching the optimal threshold of recordings during the recording periods defined in the protocol. (time frame: 16 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.