Predictive Value of the Optic Nerve Involvement in Clinically Isolated Syndrome

Condition(s) studied

Investigational drug(s) / intervention(s)

Optic 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

Study 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.

Eligibility

Primary outcome measure(s)

• 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
• 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

Trial sites (1)

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