Predictive Value of the Optic Nerve Involvement in Clinically Isolated Syndrome

NCT06455332 · University Hospital, Lille

Recruiting

In plain English

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Official title

Evaluation of the Predictive Value of the Optic Nerve Involvement at the Stage of Clinically Isolated Syndrome, for the Diagnosis of Clinically Definite Multiple Sclerosis and the Delay of Second Relapses' Occurrence

About this study

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

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

Study design

Enrollment target: 200 participants

Allocation: na

Masking: none

Age groups: adult

Timeline

Starts: 2025-07-17

Estimated completion: 2028-07-01

Last updated: 2025-08-24

Interventions

Other: Optic nerve MRI sequence

Primary outcomes

• Optic nerve involvement defined by occurrence of a recent clinical episode of ON (assessed at baseline)
• Asymptomatic optic nerve involvement defined by MRI (detection of an optic nerve T2 hypersignal) (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)

Sponsor

University Hospital, Lille · other

With: 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

Contacts & investigators

ContactJuliette Bochu · contact · juliette.bochu@chu-lille.fr · 0320444145

All locations (1)

Hôpital Roger SalengroRecruiting

Lille, France

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