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

University Hospital, Lille

Status: Enrolling

Conditions: Multiple Sclerosis; Clinically Isolated Syndrome

Treatments: Other: Optic nerve MRI sequence

Study type: Interventional

Funder types: Other

Identifiers

NCT06455332

2021_0474

Details and patient eligibility

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

All patients will part of the same follow-up study.

Experimental group

Description:

All patients will part of the same follow-up study. No treatment will be compared. Patients will be treated as recommended.

Treatment:

Other: Optic nerve MRI sequence