Clinical trial NCT06455332: Predictive Value of the Optic Nerve Involvement in Clinically Isolated Syndrome
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Clinically Isolated Syndrome
Multiple Sclerosis
Keywords: Clinically isolated syndrome
Multiple sclerosis
MRI
Optical coherence tomography
Optic nerve
Diagnostic criteria
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Région des Hauts-de-France
name: All hospitals from Région des Hauts-de-France (n=20)
name: University Hospital of Lille and Amiens
First posted: 2024-06-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Optic nerve involvement defined by occurrence of a recent clinical episode of ON
timeFrame: assessed at baseline
measure: Asymptomatic optic nerve involvement defined by MRI (detection of an optic nerve T2 hypersignal)
timeFrame: assessed at baseline
measure: Risk of a new clinical relapse will be assessed by the occurrence and time to onset of a second MS clinical relapse
timeFrame: assessed every 6 months during 24 months
measure: Asymptomatic optic nerve involvement defined by OCT (GCIPL-IETD,3pm)
timeFrame: assessed at baseline
measure: Risk of a new clinical relapse will be assessed by the occurrence and time to onset of a CDMS
timeFrame: assessed every 6 months during 24 months
Secondary outcomes:
measure: 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
timeFrame: assessed at baseline every 6 months during 24 months
measure: Time to the second clinical relapse occurrence will be assessed every 6 months during 24 months at each neurological examination
timeFrame: assessed at Month 0, Month 6, Month 12, Month 18, Month 24
Other outcomes:
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