Predictive Value of the Optic Nerve Involvement in Clinically Isolated Syndrome

NCT06455332 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-08-24

No results posted yet for this 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.

Conditions

Interventions

OTHER

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

Sponsors & Collaborators

  • Région Nord-Pas de Calais, France

    collaborator OTHER
  • Amiens University Hospital

    collaborator OTHER
  • Boulogne sur Mer Hospital Center

    collaborator OTHER
  • Centre Hospitalier VALENCIENNES

    collaborator OTHER
  • Centre Hospitalier de Roubaix

    collaborator OTHER
  • Centre Hospitalier de Lens

    collaborator OTHER
  • University Hospital, Lille

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-17
Primary Completion
2028-07-01
Completion
2028-07-01

Countries

  • France

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06455332 on ClinicalTrials.gov