RecruitingNot ApplicableNCT06455332

Predictive Value of the Optic Nerve Involvement in Clinically Isolated Syndrome

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

Sponsor

University Hospital, Lille

Enrollment

200 participants

Start Date

Jul 17, 2025

Study Type

INTERVENTIONAL

Conditions

Multiple Sclerosis Clinically Isolated Syndrome

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

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study looks at whether damage to the optic nerve (the nerve connecting your eye to your brain) can help predict whether someone with an early warning episode — called a "clinically isolated syndrome" — will go on to develop multiple sclerosis (MS). **You may be eligible if...** - You are between 18 and 55 years old - You had a first neurological episode (CIS) within the past 6 months - Your brain or spinal cord MRI shows at least two spots suggestive of MS, or you have abnormal proteins in your spinal fluid - You are willing to give written consent **You may NOT be eligible if...** - You have diabetes, glaucoma, or a retinal condition that could affect eye tests - You have had MS relapses in the past - You have extensive spinal cord damage (more than 3 vertebral bodies) - You have had optic neuritis in both eyes at the same time Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

Locations(1)

Hôpital Roger Salengro

Lille, France

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NCT06455332

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