Using optic nerve imaging to predict progression after a first demyelinating episode
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
Run by University Hospital, Lille · NCT06455332 · Data updated 2026-11-12
This trial will try a dedicated optic nerve MRI in people who recently had a first demyelinating event (clinically isolated syndrome) to see if optic nerve involvement predicts who will have a second relapse and be diagnosed with multiple sclerosis.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 55 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | University Hospital, Lille Academic / other |
| Locations | 1 site (Lille) |
| Status | Recruiting |
| Started | July 17, 2025 |
| Main results expected | July 1, 2028 |
| Study ends | July 1, 2028 |
| Registry record updated | August 24, 2025 |
| Trial ID | NCT06455332 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–55 with a first demyelinating episode within the past 6 months, plus two T2 lesions on brain/spinal MRI or oligoclonal bands, who can undergo MRI and give informed consent.
✕Probably not a fit
Patients with prior MS relapses, extensive myelitis (>3 vertebral bodies), bilateral optic neuritis without supportive T2 lesions, significant eye disease (e.g., advanced glaucoma, diabetic retinopathy, high ametropia), pregnancy, or MRI/gadolinium contraindications are unlikely to benefit from this imaging-based prediction.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter prospective imaging study will enroll adults 18–55 with a recent clinically isolated syndrome (≤6 months) who have either two T2 lesions suggestive of MS or cerebrospinal oligoclonal bands. Participants receive a standardized dedicated optic nerve MRI sequence at baseline to detect symptomatic or asymptomatic optic nerve involvement. Key exclusions include ocular diseases that affect imaging, prior MS relapses, extensive myelitis, and MRI contraindications to avoid confounding results. Investigators will follow participants for occurrence and timing of a second clinical relapse to compare conversion rates and delay to second relapse between those with and without optic nerve involvement on MRI.
Why it matters
Potential benefit: If successful, this could help doctors identify which patients with a first demyelinating event are more likely to have a second relapse so they can consider earlier treatment or closer monitoring.
How similar studies have gone: Previous OCT and optic nerve imaging reports suggest optic nerve damage can predict conversion to MS, but prospective multicenter use of dedicated optic nerve MRI for this purpose is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Hôpital Roger Salengro
Lille, France Recruiting
Study contacts
- Study coordinator: Juliette Bochu
- Email: juliette.bochu@chu-lille.fr
- Phone: 0320444145
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.