Observational study on Radiologically Isolated Syndrome and Multiple Sclerosis
Official title: The Radiologically Isolated Syndrome International Cohort
Run by Centre Hospitalier Universitaire de Nice · NCT05388331 · Data updated 2026-11-12
This study looks at people with Radiologically Isolated Syndrome to see how their brain changes over time and if these changes might lead to Multiple Sclerosis.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | Centre Hospitalier Universitaire de Nice Academic / other |
| Locations | 1 site (Nice) |
| Status | Recruiting |
| Started | April 15, 2022 |
| Main results expected | April 15, 2023 |
| Study ends | April 15, 2029 |
| Registry record updated | May 24, 2022 |
| Trial ID | NCT05388331 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are asymptomatic individuals with white matter T2 lesions suggestive of demyelination and a normal neurological exam.
✕Probably not a fit
Patients with abnormal neurological exams or those with other diseases explaining their MRI lesions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study focuses on individuals with Radiologically Isolated Syndrome (RIS), characterized by white matter abnormalities detected through MRI without prior neurological symptoms. The study aims to track the progression of these abnormalities and identify factors that may predict the development of clinical demyelinating events. Participants will undergo regular monitoring to assess any changes in their neurological status over time. The study is part of a larger effort to understand the natural history of RIS and its potential progression to Multiple Sclerosis.
Why it matters
Potential benefit: If successful, this study could enhance early detection and management strategies for patients at risk of developing Multiple Sclerosis.
How similar studies have gone: Previous studies have shown that a significant percentage of individuals with RIS may progress to clinical demyelinating events, indicating that this area of research is both relevant and potentially impactful.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * white matter T2 lesions suggestive of demyelination * asymptomatic * normal neurological exam Exclusion Criteria: * abnormal neurological exam, * suspicion of another disease explaining MRI lesions.
Where it's running
-
Nice University Hospital
Nice, France Recruiting
Study contacts
- Study coordinator: Christine LEBNRUN-FRENAY
- Email: lebrun-frenay.c@chu-nice.fr
- Phone: 33 4 92 03 41 26
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.