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Predictive Value of the Optic Nerve Involvement in Clinically Isolated Syndrome

RECRUITINGN/ASponsored by University Hospital, Lille
Actively Recruiting
PhaseN/A
SponsorUniversity Hospital, Lille
Started2025-07-17
Est. completion2028-07-01
Eligibility
Age18 Years – 55 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06455332

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.

Eligibility

Age: 18 Years – 55 YearsHealthy volunteers accepted
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

Conditions2

Clinically Isolated SyndromeMultiple Sclerosis

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