Clinically Isolated Syndrome, Multiple Sclerosis
Conditions
Keywords
Clinically isolated syndrome, Multiple sclerosis, MRI, Optical coherence tomography, Optic nerve, Diagnostic criteria
Brief summary
Optic neuritis (ON) represents around 30% of clinical presentation of clinically isolated syndrome (CIS). Asymptomatic optic nerve involvement is very frequent in all stage of multiple sclerosis (MS) disease including the CIS. However, optic nerve is still not part of MS diagnosis criteria. The main objective of our regional and multicenter study is to evaluate the prognostic value of optic nerve involvement at the earliest clinical stage of MS (=CIS) for the diagnosis of clinically definite MS (2nd clinical relapse) and the delay until the 2nd relapse.
Interventions
OTHEROptic nerve MRI sequence
Systematic optic nerve MRI sequence during the CIS diagnosis work-up. This sequence is not done systematically and not recommended for now (except in case of acute ON). The interventional nature of the study remains minimal
Sponsors
Région Nord-Pas de Calais, France
Amiens University Hospital
Boulogne sur Mer Hospital Center
Centre Hospitalier VALENCIENNES
Centre Hospitalier de Roubaix
Centre Hospitalier de Lens
University Hospital, Lille
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Patients between 18 and 55 years old * Occurrence of CIS ≤ 6 months * With two T2 hypersignals on brain/spinal cord MRI suggestive of MS or with oligoclonal bands * Giving their written informed consent
Exclusion criteria
* Pathological conditions that may skew the optic nerve MRI and/or retinal OCT (diabetes mellitus, glaucoma, retinopathy, ametropia \>6 dioptria) * Past history of MS relapses * Extensive myelitis (\>3 vertebral bodies) * Bilateral optic neuritis without T2 lesions suggestive of MS * Contra-indication to MRI, gadolinium injection * Pregnancy, breast-feeding * Patients unable to consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Asymptomatic optic nerve involvement defined by MRI (detection of an optic nerve T2 hypersignal) | assessed at baseline |
| Asymptomatic optic nerve involvement defined by OCT (GCIPL-IETD,3pm) | assessed at baseline |
| Risk of a new clinical relapse will be assessed by the occurrence and time to onset of a CDMS | assessed every 6 months during 24 months |
| Optic nerve involvement defined by occurrence of a recent clinical episode of ON | assessed at baseline |
| Risk of a new clinical relapse will be assessed by the occurrence and time to onset of a second MS clinical relapse | assessed every 6 months during 24 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to the second clinical relapse occurrence will be assessed every 6 months during 24 months at each neurological examination | assessed at Month 0, Month 6, Month 12, Month 18, Month 24 | — |
| Asymptomatic optic nerve involvement will be defined by: - asymptomatic optic nerve T2 hypersignal detected on one or both optic nerve(s) - or by GCIPL-IETD,3pm measured by OCT - or by GCIPL-IETD≥3µm measured by OCT | assessed at baseline every 6 months during 24 months | Time to the second clinical relapse occurrence will be assessed every 6 months during 24 months at each neurological examination (M0, M6, M12, M18, M24) |
Countries
France
Contacts
Primary ContactJuliette Bochu
Outcome results
None listed