Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2026-03-27 @ 1:12 PM
Study NCT ID:
NCT06346704
Status:
TERMINATED
Last Update Posted:
2025-12-15
First Post:
2024-03-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Longitudinal Monocentric Study to Evaluate the Syde® Digital Endpoint in Patients With Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}, 'patientRegistry': False}, 'statusModule': {'whyStopped': "Sponsor's decision", 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-04-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-05', 'studyFirstSubmitDate': '2024-03-29', 'studyFirstSubmitQcDate': '2024-03-29', 'lastUpdatePostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Longitudinal change of 95th centile of stride velocity', 'timeFrame': '2 years', 'description': 'change between baseline and Month 6, Month 12, Month 18 and Month 24'}], 'secondaryOutcomes': [{'measure': 'Correlation of the Syde® variables with the clinical assessments EDSS, FSS and T25FWT', 'timeFrame': '2 years'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Digital Health Technology'], 'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'The study aims to assess the validity of real-world activity monitoring by the Syde® wearable device in subjects with multiple slclerosis. The Syde® collected data will be compared to on-site conventional clinical endpoints for MS pathology (EDSS, FSS and T25FWT). Subjects with multiple sclerosis will be assessed every 6 months for 2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects followed for multiple sclerosis care at the investigational site.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female subject aged from 18 to 65 years old.\n2. Signed informed consent and ability to comply with study and follow-up.\n3. Diagnosed with MS base on 2017 McDonald criterion\n4. EDSS ≤ 5.5\n5. No clinical or radiological relapse within the last 3 months\n6. For patient under treatment, the molecule and its dose should be stable about 2 months before inclusion\n7. Subject willing and able to comply to all study procedures including the Syde® related ones\n\nExclusion Criteria:\n\n1. Patient with a cognitive or communicational disorder disturbing the understanding of the tasks or data collection\n2. Previous or current disorder with an impact on current ambulation or motor function\n3. Patient who have had surgery or traumatic injury in upper or lower limb within the last 6 months before the inclusion or patients who have had major surgery or trauma within the last 6 months before the inclusion'}, 'identificationModule': {'nctId': 'NCT06346704', 'acronym': 'NHS-MS-EGYPT', 'briefTitle': 'Prospective Longitudinal Monocentric Study to Evaluate the Syde® Digital Endpoint in Patients With Multiple Sclerosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'SYSNAV'}, 'officialTitle': 'Prospective Longitudinal Monocentric Study to Evaluate the Syde® Digital Endpoint in Patients With Multiple Sclerosis (NHS-MS-EGYPT)', 'orgStudyIdInfo': {'id': 'PR5030-66'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Digital HealthTechnology', 'type': 'OTHER', 'otherNames': ['Syde®'], 'description': 'Subject will wear the Syde® for 1 month every 6 months'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Air Force Specialized Hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Ahmed Elnemr, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Air Force Specialized Hospital Cairo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SYSNAV', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}