Observational study on Radiologically Isolated Syndrome and Multiple Sclerosis
The Radiologically Isolated Syndrome International Cohort
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 |
|---|---|
| Enrollment | 1000 (estimated) |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Nice Academic / other |
| Locations | 1 site (Nice) |
| Trial ID | NCT05388331 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are asymptomatic individuals with white matter T2 lesions suggestive of demyelination and a normal neurological exam.
Not a fit: Patients with abnormal neurological exams or those with other diseases explaining their MRI lesions may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Nice
- 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
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.