Predictive Value of the Optic Nerve Involvement in Clinically Isolated Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-17

Study Completion Date

2028-07-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Clinically Isolated Syndrome Multiple Sclerosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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All patients will part of the same follow-up study.

All patients will part of the same follow-up study. No treatment will be compared. Patients will be treated as recommended.

Group Type EXPERIMENTAL

Optic nerve MRI sequence

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No