Prospective Longitudinal Monocentric Study to Evaluate the Syde® Digital Endpoint in Patients With Multiple Sclerosis

Active, not recruiting

• Conditions: Multiple Sclerosis

• Registration Number: NCT06346704
• Lead Sponsor: SYSNAV

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-29
• Study First Submitted QC: 2024-03-29
• Study First Posted: 2024-04-04
• Study Start: 2024-04-25
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-27
• Last Update Posted: 2024-12-30
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Male or female subject aged from 18 to 65 years old.
2. Signed informed consent and ability to comply with study and follow-up.
3. Diagnosed with MS base on 2017 McDonald criterion
4. EDSS ≤ 5.5
5. No clinical or radiological relapse within the last 3 months
6. For patient under treatment, the molecule and its dose should be stable about 2 months before inclusion
7. Subject willing and able to comply to all study procedures including the Syde® related ones

Exclusion Criteria

1. Patient with a cognitive or communicational disorder disturbing the understanding of the tasks or data collection
2. Previous or current disorder with an impact on current ambulation or motor function
3. 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Longitudinal change of 95th centile of stride velocity	2 years	change between baseline and Month 6, Month 12, Month 18 and Month 24

Secondary Outcome Measures

Name	Time	Method
Correlation of the Syde® variables with the clinical assessments EDSS, FSS and T25FWT	2 years

Trial Locations

Locations (1)

Air Force Specialized Hospital; 🇪🇬 Cairo, Egypt