Multiple SclerosisNHS-MS-EGYPTNCT06346704
Prospective Longitudinal Monocentric Study to Evaluate the Syde® Digital Endpoint in Patients With Multiple Sclerosis
An observational study of Multiple Sclerosis, run by SYSNAV at 1 site in Egypt.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Digital HealthTechnology
- How many people
- 86 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Apr 2024to 25 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Study population: Subjects followed for multiple sclerosis care at the investigational site.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Digital HealthTechnology
- Keywords
- Digital Health Technology
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital HealthTechnologyOther
Also called Syde®
Subject will wear the Syde® for 1 month every 6 months
What is being measured
The primary outcome is the main question the study is designed to answer.
Longitudinal change of 95th centile of stride velocity
change between baseline and Month 6, Month 12, Month 18 and Month 24
Measured: 2 years
Secondary outcomes (1)
Correlation of the Syde® variables with the clinical assessments EDSS, FSS and T25FWT
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start25 Apr 2024
- Primary completion25 Apr 2025
- Study completion25 Apr 2025
Why it stopped: Sponsor's decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- SYSNAV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ahmed Elnemr, MD, Principal investigator, Air Force Specialized Hospital Cairo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06346704
- Sponsor's protocol ID
- PR5030-66
- Acronym
- NHS-MS-EGYPT
- Status last verified
- Oct 2025
- First submitted
- 29 Mar 2024
- Last updated
- 15 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Longitudinal Monocentric Study to Evaluate the Syde® Digital Endpoint in Patients With Multiple Sclerosis (NHS-MS-EGYPT)
- ClinicalTrials.gov ID
- NCT06346704
- Acronym / sponsor ID
- NHS-MS-EGYPT / PR5030-66
- Conditions
- Multiple Sclerosis
- Keywords
- Digital Health Technology
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor's decision
- Enrolment
- 86 participants (actual)
- Lead sponsor
- SYSNAVIndustry (pharma, biotech, devices)
- Study start
- 25 Apr 2024 (actual)
- Primary completion
- 25 Apr 2025 (actual)
- Study completion
- 25 Apr 2025 (actual)
- First posted
- 4 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subjects followed for multiple sclerosis care at the investigational site.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital HealthTechnologyAlso: Syde®Subject will wear the Syde® for 1 month every 6 months | Other | – |
Primary outcome
Longitudinal change of 95th centile of stride velocity
Time frame: 2 years
change between baseline and Month 6, Month 12, Month 18 and Month 24
1 secondary outcome
Correlation of the Syde® variables with the clinical assessments EDSS, FSS and T25FWT
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Sponsor's decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Elnemr, MD principal investigator
Air Force Specialized Hospital Cairo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by SYSNAV at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Sponsor's decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Longitudinal change of 95th centile of stride velocity (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.