Digital biomarkers in people with radiologically isolated syndrome and MS who have normal neurological exams
Comparison of Digital Biomarkers in Subjects With Radiologically Isolated Syndrome (RIS) and Multiple Sclerosis (MS) Patients With Clinically Normal Neurological Examination
NA · Centre Hospitalier Universitaire de Nice · NCT07135752
This study will test whether digital biomarkers can tell apart people with radiologically isolated syndrome from multiple sclerosis patients who have a normal neurological exam.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Nice (other) |
| Locations | 1 site (Nice) |
| Trial ID | NCT07135752 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults in France with RIS by the 2023 criteria or people with MS who have a normal neurological exam by McDonald 2017, who are covered by social security and do not have progressive disease or unrelated neurological deficits.
Not a fit: People with progressive MS or with motor, visual, or cognitive impairments unrelated to MS that interfere with testing are unlikely to gain benefit from this study's comparisons.
Why it matters
Potential benefit: If successful, this approach could offer noninvasive, more frequent monitoring to help identify people at higher risk of converting from RIS to symptomatic MS earlier.
How similar studies have performed: Epidemiological RIS cohorts have identified imaging and clinical risk factors for conversion, and early work on digital biomarkers in MS is promising but has not yet produced widely adopted clinical tools.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Nice
- CHU de Nice — Nice, France (RECRUITING)
Study contacts
- Study coordinator: Mikael COHEN, MD, PhD
- Email: cohen.m@chu-nice.fr
- Phone: +33678601965
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Radiologically Isolated Syndromes, Multiple Sclerosis