Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 11:04 AM
Study NCT ID:
NCT07389018
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-20
First Post:
2026-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Feasibility of Syde® Digital Endpoints for Monitoring Patients With Progressive Supranuclear Palsy - Richardson Syndrome (PSP-R)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-18', 'studyFirstSubmitDate': '2026-01-28', 'studyFirstSubmitQcDate': '2026-01-28', 'lastUpdatePostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients reaching the optimal threshold of recordings during the recording periods defined in the protocol.', 'timeFrame': '16 months', 'description': '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.'}, {'measure': 'French Usability score (F-SUS) at Month 4 and at the end of the study', 'timeFrame': '16 months', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in the total wearing time at months 4, 8, 12, and 16.', 'timeFrame': '16 months', 'description': 'Change from baseline in the total wearing time at months 4, 8, 12, and 16.'}, {'measure': 'Reproducibility of Syde® digital endpoints for each recording period timepoint', 'timeFrame': '16 months', 'description': '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)'}, {'measure': 'Correlation between Syde® digital endpoints and 2-minute walk test (2MWT)', 'timeFrame': '16 months', 'description': 'Correlation at baseline and at different timepoints between Syde® digital endpoints and 2MWT'}, {'measure': 'Correlation between Syde® digital endpoints and 10-meter walk test (10MWT)', 'timeFrame': '16 months', 'description': 'Correlation at baseline and at different timepoints between Syde® digital endpoints and 10MWT'}, {'measure': 'Correlation between Syde® digital endpoints and Timed Up and Go (TUG)', 'timeFrame': '16 months', 'description': 'Correlation at baseline and at different timepoints between Syde® digital endpoints and TUG'}, {'measure': 'Correlation between Syde® digital endpoints and falls reported by the participants', 'timeFrame': '16 months', 'description': 'Correlation at baseline and at different timepoints between Syde® digital endpoints and falls reported by the participants'}, {'measure': 'Correlation between Syde® digital endpoints and Progressive Supranuclear Palsy Rating Scale (PSP-RS)', 'timeFrame': '16 months', 'description': 'Correlation at baseline and at different timepoints between Syde® digital endpoints and PSP-RS'}, {'measure': 'Correlation between Syde® digital endpoints and Progressive Supranuclear Palsy Clinical Deficits Scale (PSP-CDS)', 'timeFrame': '16 months', 'description': 'Correlation at baseline and at different timepoints between Syde® digital endpoints and PSP-CDS'}, {'measure': 'Correlation between Syde® digital endpoints and Montreal Cognitive Assessment (MoCA)', 'timeFrame': '16 months', 'description': 'Correlation at baseline and at different timepoints between Syde® digital endpoints and MoCA'}, {'measure': 'Longitudinal change in Syde® digital endpoints. The Syde® digital endpoints will include the SV95C (Stride Velocity 95th centile)', 'timeFrame': '16 months', 'description': '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)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Progressive Supranuclear Palsy- Richardson Syndrome (PSP-R)']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients With Progressive Supranuclear Palsy - Richardson Syndrome (PSP-R)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1.18 years old or older\n\n2.Participants affiliated to, or beneficiary from, a social security.\n\n3.Ambulant patients (i.e. able to walk 10 meters without assistance)\n\n4.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..\n\n5.Possible or probable PSP-R according to MDS criteria 2017(Hoglinger et al., Mov Disorder, 2017).\n\nExclusion Criteria:\n\n1. 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.\n2. Patients who do not tolerate to keep the sensors on their ankles.\n3. Patients who have undergone a surgical procedure or who have experienced recent trauma (within fewer than 6 months) affecting the lower limbs.\n4. A concomitant chronic or acute neurological, endocrine, infectious, allergic, or inflammatory pathology within the 3-week period immediately prior to inclusion.\n5. Patients affected by any other disorder having a significant impact on gait or lower limb function.\n6. Participant covered by a legal protection measure (guardianship, curatorship or safeguarding of justice) or who is unable to express their consent.\n7. Absence of caregiver.'}, 'identificationModule': {'nctId': 'NCT07389018', 'acronym': 'PROSPER-SYDE', 'briefTitle': 'Study to Evaluate the Feasibility of Syde® Digital Endpoints for Monitoring Patients With Progressive Supranuclear Palsy - Richardson Syndrome (PSP-R)', 'organization': {'class': 'INDUSTRY', 'fullName': 'SYSNAV'}, 'officialTitle': 'Prospective Longitudinal Monocentric Study to Evaluate the Feasibility of Syde® Digital Endpoints for Monitoring Patients With Progressive Supranuclear Palsy - Richardson Syndrome (PSP-R)', 'orgStudyIdInfo': {'id': 'PR5030-76'}, 'secondaryIdInfos': [{'id': '2024-A02611-46', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75019', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Fondation Adolphe de Rothschild', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Ferial Toumi', 'role': 'CONTACT', 'email': 'ferial.toumi@sysnav.fr', 'phone': '+33 2 78 00 10 98'}], 'overallOfficials': [{'name': 'Jean-Philippe BRANDEL', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hopital Fondation Adolphe de Rothschild'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SYSNAV', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}