Actively Recruiting

Phase Not Applicable
Age: 18Years - 55Years
All Genders
NCT06455332

Predictive Value of the Optic Nerve Involvement in Clinically Isolated Syndrome

Led by University Hospital, Lille · Updated on 2025-08-24

200

Participants Needed

1

Research Sites

154 weeks

Total Duration

On this page

Sponsors

U

University Hospital, Lille

Lead Sponsor

R

Région Nord-Pas de Calais, France

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Predictive Value of the Optic Nerve Involvement in Clinically Isolated Syndrome

Who Can Participate

Age: 18Years - 55Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients between 18 and 55 years old
  • Occurrence of clinically isolated syndrome (CIS) within 6 months
  • Presence of two T2 hypersignals on brain or spinal cord MRI suggestive of multiple sclerosis or presence of oligoclonal bands
  • Able and willing to provide written informed consent
Not Eligible

You will not qualify if you...

  • Presence of eye conditions that could affect optic nerve MRI or retinal OCT, such as diabetes mellitus, glaucoma, retinopathy, or ametropia greater than 6 diopters
  • History of multiple sclerosis relapses
  • Extensive myelitis longer than 3 vertebral bodies
  • Bilateral optic neuritis without T2 lesions suggestive of multiple sclerosis
  • Contraindications to MRI or gadolinium injection
  • Pregnancy or breastfeeding
  • Unable to provide informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hôpital Roger Salengro

Lille, France, 59037

Actively Recruiting

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Research Team

J

Juliette Bochu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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