Optic Nerve Involvement in Clinically Isolated Syndrome
Predictive Value of the Optic Nerve Involvement in Clinically Isolated Syndrome
Recruiting
N/AInterventional Study
Clinically Isolated SyndromeMultiple Sclerosis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 55
Sex
Any
Study type
Interventional
Purpose
Diagnostic
Participants needed
200 (estimated)
Sponsor
University Hospital, Lille · Other
Who this trial is looking for
This trial is looking for adults with clinically isolated syndrome to see how optic nerve involvement can help predict multiple sclerosis. Participants will undergo MRI tests and must agree to be part of the study by giving their written consent.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 55 years old
I have been diagnosed with clinically isolated syndrome for 6 months or less
I have two brain/spinal cord MRI findings that suggest multiple sclerosis
I have oligoclonal bands in my spinal fluid
I will give my written consent
You may not be able to join if
I have diabetes mellitus
I have glaucoma
I have retinopathy
I have ametropia greater than 6 diopters
I have had multiple sclerosis relapses in the past
I have extensive myelitis affecting more than 3 vertebral bodies
I have had bilateral optic neuritis without MRI lesions suggestive of multiple sclerosis
I cannot have an MRI or a gadolinium injection
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 …
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.
Trial Locations
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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 ne…
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
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