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

NCT06346704 | Terminated

• 1 other identifier: PR5030-66
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Digital Health Technology

Outcome Measures

Primary Outcomes (1)

• Longitudinal change of 95th centile of stride velocity

  change between baseline and Month 6, Month 12, Month 18 and Month 24

  2 years

Secondary Outcomes (1)

• Correlation of the Syde® variables with the clinical assessments EDSS, FSS and T25FWT

  2 years

Interventions

Digital HealthTechnology OTHER

Subject will wear the Syde® for 1 month every 6 months

Also known as: Syde®

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects followed for multiple sclerosis care at the investigational site.

You may qualify if:

• 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
• Subject willing and able to comply to all study procedures including the Syde® related ones

You may not qualify if:

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

Sponsors & Collaborators

• SYSNAV: lead

Study Sites (1)

Air Force Specialized Hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Ahmed Elnemr, MD

  Air Force Specialized Hospital Cairo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: April 4, 2024
• Study Start: April 25, 2024
• Primary Completion: April 25, 2025
• Study Completion: April 25, 2025
• Last Updated: December 15, 2025

Record last verified: 2025-10

Locations

EG (1)