Predictive Value of the Optic Nerve Involvement in Clinically Isolated Syndrome

Not Applicable

Not yet recruiting

• Conditions: Multiple Sclerosis; Clinically Isolated Syndrome
• Interventions: Other: Optic nerve MRI sequence

• Registration Number: NCT06455332
• Lead Sponsor: University Hospital, Lille

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-23
• Study First Submitted QC: 2024-06-06
• Last Update Submitted: 2024-06-06
• Study First Posted: 2024-06-12
• Last Update Posted: 2024-06-12
• Study Start: 2024-07-01
• Primary Completion: 2028-07-01
• Study Completion: 2028-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All patients will part of the same follow-up study.	Optic nerve MRI sequence	All patients will part of the same follow-up study. No treatment will be compared. Patients will be treated as recommended.

Primary Outcome Measures

Name	Time	Method
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
Asymptomatic optic nerve involvement defined by MRI (detection of an optic nerve T2 hypersignal)	assessed at baseline
Asymptomatic optic nerve involvement defined by OCT (GCIPL-IETD,3pm)	assessed at baseline
Optic nerve involvement defined by occurrence of a recent clinical episode of ON	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

Secondary Outcome Measures

Name	Time	Method
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
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	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 (M0, M6, M12, M18, M24)