Prospective Longitudinal Monocentric Study to Evaluate the Syde® Digital Endpoint in Patients With Multiple Sclerosis
Megadott ok: Sponsor's decision
Key facts
- Where
- Cairo, EgyiptomSee the site
Where in Egyiptom
- Air Force Specialized HospitalCairo, EgyiptomNo longer taking part
Trial details
- Who runs it
- SYSNAV
- Trial code
- NCT06346704
- Record updated
- 2025. december 15.
- Original description
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.Read full original descriptionShow less
Prospective Longitudinal Monocentric Study to Evaluate the Syde® Digital Endpoint in Patients With Multiple Sclerosis (NHS-MS-EGYPT)
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.
Inclusion: Male or female subject aged from 18 to 65 years old; Signed informed consent and ability to comply with study and follow-up; Diagnosed with MS base on 2017 McDonald criterion; EDSS ≤ 5.5; No clinical or radiological relapse within the last 3 months; For patient under treatment, the molecule and its dose should be stable about 2 months before inclusion; Subject willing and able to comply to all study procedures including the Syde® related ones.
Exclusion: Previous or current disorder with an impact on current ambulation or motor function; 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; Patient with a cognitive or communicational disorder disturbing the understanding of the tasks or data collection.