Predictive Value of the Optic Nerve Involvement in Clinically Isolated Syndrome

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorUniversity Hospital, Lille

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Optic nerve MRI sequence

Treatment groups

200 Participants
are divided into 1 treatment group

Sponsors and collaborators

University Hospital, Lille

Lead sponsor

Région Nord-Pas de Calais, France

Collaborator

Amiens University Hospital

Collaborator

Boulogne sur Mer Hospital Center

Collaborator

Centre Hospitalier VALENCIENNES

Collaborator

Centre Hospitalier de Roubaix

Collaborator

Centre Hospitalier de Lens

Collaborator