RIS International Cohort
- Conditions
- Radiologically Isolated SyndromeMultiple Sclerosis
- Interventions
- Other: No intervention
- Registration Number
- NCT05388331
- Lead Sponsor
- Centre Hospitalier Universitaire de Nice
- Brief Summary
The Radiologically Isolated Syndrome (RIS) corresponds to the discovery of white matter (WM) abnormalities suggestive of multiple sclerosis (MS) by their location, size, and appearance, on the brain or spinal cord Magnetic Resonance Imaging (MRI). This imaging is performed for a reason other than for suspicion of demyelinating disease in subjects without a history of neurological symptoms and a strict routine clinical neurological examination. It was defined and named in 2009 (Okuda et al.) after publishing 3 case series (French, USA, Turkey). The Radiologically Isolated Syndrome Consortium (RISC) published a cohort of subjects with an extended follow-up after the first brain MRI of MS, with 34% presenting an event (clinical conversion) at five years, 51.2 % of these subjects showed an event at ten years. The patients who offer a higher risk of developing a first clinical demyelinating event were identified such as male sex, young age, the presence of oligoclonal bands (BOCs) in the Cerebrospinal Fluid (CSF), the presence of infratentorial lesions and spinal cord lesions on the first MRI suggestive of RIS. The location and morphology of the lesions appear to be decisive for studying the risk of conversion. Our first objective is to prospectively collect data to identify the subjects who present a higher risk of developing a first clinical demyelinating event and the progression of the disease in these subjects.
Among the objectives of this worldwide cohort is the analysis of (1) environmental factors (Vit D, EBV, tobacco...), (2) MRI biomarkers, including atrophy, central veins signs, paramagnetic rings, and DTI.
(3) digital biomarkers (4) oculography (5) biological markers To summarize, this cohort will allow for analyzing features in imaging, biology and the exploration of digital and oculographic characteristics to identify predictive factors of clinical evolution of a large cohort of subjects presenting WM abnormalities suggestive of multiple sclerosis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
- white matter T2 lesions suggestive of demyelination
- asymptomatic
- normal neurological exam
- abnormal neurological exam,
- suspicion of another disease explaining MRI lesions.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description NON RIS/0 criteria No intervention - RIS/1-2 criteria No intervention - RIS/3-4 criteria No intervention -
- Primary Outcome Measures
Name Time Method Identification of lesions T2-weighted sequence at the index scan at inclusion localisation of interest of T2 lesion (juxtacortical, periventricular, infratentorial, spinal cord)
Identification of lesions T1 sequence with and without Gd at the index scan. at inclusion localisation of interest
Radiological progression : new T2 lesions MS onset assessed up to 2 years localisation of interest of T2 lesion
Radiological progression : new contrast enhancing lesions MS onset assessed up to 2 years localisation of interest
Brain atrophy MS onset assessed up to 2 years measurement of global and regional grey matter volume measurement of global and regional white matter volume
- Secondary Outcome Measures
Name Time Method Collect biological data MS onset assessed up to 2 years number of plasma samples
Collect digital markers MS onset assessed up to 2 years Progression of the number of abnormalities identified by the eVOG application correlated with cerebral atrophy
Trial Locations
- Locations (1)
Nice University Hospital
🇫🇷Nice, France