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
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
- Clinically Isolated Syndrome
- Multiple Sclerosis
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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