Digital biomarkers in people with radiologically isolated syndrome and MS who have normal neurological exams

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants include people with radiologically isolated syndrome (RIS) who meet the 2023 criteria and people with multiple sclerosis who have a clinically normal neurological exam under McDonald 2017 criteria. At CHU de Nice, both groups will undergo precision assessments of digital biomarkers, with the resulting digital measures compared between groups. Clinical and imaging information, including routine MRI findings, will be used alongside digital data to look for patterns that differ between RIS and clinically silent MS and might predict future conversion. The protocol excludes people with unrelated motor, visual, or cognitive deficits and anyone with progressive MS, and participants must be affiliated to social security.

Why it matters

Who can join: the full rules

Inclusion Criteria:

RIS patients:

* Patients fulfilling the 2023 diagnostic RIS criteria
* Patients with a radiologically isolated syndrome (RIS) identified in local OFSEP databases (French Multiple Sclerosis Observatory)

MS patients:

\- Patients with a normal neurological examination fulfilling the McDonald 2017 MS diagnostic criteria

For both groups:

\- Patient affiliated to social security

Exclusion Criteria:

* The presence of motor, visual or cognitive deficits unrelated to MS that may interfere with test performance
* A diagnosis of progressive MS

Where it's running

• CHU de Nice
  Nice, France Recruiting

Study contacts

• Study coordinator: Mikael COHEN, MD, PhD
• Email: cohen.m@chu-nice.fr
• Phone: +33678601965

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.