Predictive Value of the Optic Nerve Involvement in Clinically Isolated Syndrome (HdeFIMS)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Multiple Sclerosis; Clinically Isolated Syndrome
• Intervention / Treatment: Other: Optic nerve MRI sequence

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Juliette Bochu; Phone Number: 0320444145; Email: juliette.bochu@chu-lille.fr

Study Locations

• France
  • Lille, France, 59037
    • Recruiting
    • Hôpital Roger Salengro
    • Contact: Olivier Outteryck

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Optic nerve involvement defined by occurrence of a recent clinical episode of ON	assessed at baseline
Asymptomatic optic nerve involvement defined by MRI (detection of an optic nerve T2 hypersignal)	assessed at baseline
Risk of a new clinical relapse will be assessed by the occurrence and time to onset of a second MS clinical relapse	assessed every 6 months during 24 months
Asymptomatic optic nerve involvement defined by OCT (GCIPL-IETD,3pm)	assessed at baseline
Risk of a new clinical relapse will be assessed by the occurrence and time to onset of a CDMS	assessed every 6 months during 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asymptomatic optic nerve involvement will be defined by: - asymptomatic optic nerve T2 hypersignal detected on one or both optic nerve(s) - or by GCIPL-IETD,3pm measured by OCT - or by GCIPL-IETD≥3µm measured by OCT	Time to the second clinical relapse occurrence will be assessed every 6 months during 24 months at each neurological examination (M0, M6, M12, M18, M24)	assessed at baseline every 6 months during 24 months
Time to the second clinical relapse occurrence will be assessed every 6 months during 24 months at each neurological examination		assessed at Month 0, Month 6, Month 12, Month 18, Month 24

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Collaborators: Amiens University Hospital; Centre Hospitalier de Roubaix; Région Nord-Pas de Calais, France; Centre Hospitalier de Lens; Boulogne sur Mer Hospital Center; Centre Hospitalier VALENCIENNES

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: May 23, 2024
• First Submitted That Met QC Criteria: June 6, 2024
• First Posted (Actual): June 12, 2024

Study Record Updates

• Last Update Posted (Actual): August 24, 2025
• Last Update Submitted That Met QC Criteria: August 19, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: MRI; Clinically isolated syndrome; Optical coherence tomography; Multiple sclerosis; Diagnostic criteria; Optic nerve
• Additional Relevant MeSH Terms: Nervous System Diseases; Pathologic Processes; Autoimmune Diseases; Immune System Diseases; Disease; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Syndrome; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 2021_0474

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No