Prospective Longitudinal Monocentric Study to Evaluate th... | NCT06346704

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

NCT06346704

Sponsor

SYSNAV

Status

Terminated

Last Update Posted

Dec 15, 2025Actual

Enrollment

86Actual

Phase

Not provided

Conditions

Multiple Sclerosis

Interventions

Digital HealthTechnology

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2025

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sponsor's decision

Expanded Access Info

Start Date

Apr 25, 2024Actual

Primary Completion Date

Apr 25, 2025Actual

Completion Date

Apr 25, 2025Actual

First Submitted Date

Mar 29, 2024

First Submission Date that Met QC Criteria

Mar 29, 2024

First Posted Date

Apr 4, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 5, 2025

Last Update Posted Date

Dec 15, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

86Actual

Name	Type	Description	Arm Group Labels	Other Names
Digital HealthTechnology	Other	Subject will wear the Syde® for 1 month every 6 months		Syde®

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Correlation of the Syde® variables with the clinical assessments EDSS, FSS and T25FWT		2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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
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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Subjects followed for multiple sclerosis care at the investigational site.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ahmed Elnemr, MD	Air Force Specialized Hospital Cairo	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Air Force Specialized Hospital		Cairo			Egypt

Condition Browse Module

MeSH Terms

ID	Term
D009103	Multiple Sclerosis

Ancestor Terms

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases

Browse Leaves

Not provided

Browse Branches

Not provided