Predictive Value of the Optic Nerve Involvement in Clinically Isolated Syndrome
Recruiting · NCT06455332 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital, Lille
View the official record on ClinicalTrials.gov →Interventions studied
Optic nerve MRI sequence
What this trial is about
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.
Who can take part
Age range
18 Years to 55 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Hôpital Roger Salengro - Lille, France