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

Multiple Sclerosis Clinical Trial

— NHS-MS-EGYPT  

Official title:

Prospective Longitudinal Monocentric Study to Evaluate the Syde® Digital Endpoint in Patients With Multiple Sclerosis (NHS-MS-EGYPT)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06346704
• Other study ID #: PR5030-66
• Status: Active, not recruiting
• Start date: April 25, 2024
• Est. completion date: November 30, 2026

Study information

• Verified date: May 2024
• Source: SYSNAV
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 61
• Est. completion date: November 30, 2026
• Est. primary completion date: November 30, 2026
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Digital HealthTechnology
Subject will wear the Syde® for 1 month every 6 months

Locations

Country	Name	City	State
Egypt	Air Force Specialized Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
SYSNAV

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Longitudinal change of 95th centile of stride velocity	change between baseline and Month 6, Month 12, Month 18 and Month 24	2 years
Secondary	Correlation of the Syde® variables with the clinical assessments EDSS, FSS and T25FWT		2 years