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Recruiting NCT06455332

Predictive Value of the Optic Nerve Involvement in Clinically Isolated Syndrome

No phase Interventional Clinically Isolated Syndrome Multiple Sclerosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Optic nerve MRI sequence.
Who it may be relevant to
Registry conditions: Clinically Isolated Syndrome, Multiple Sclerosis. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

  • Other Optic nerve MRI sequence
    Systematic optic nerve MRI sequence during the CIS diagnosis work-up. This sequence is not done systematically and not recommended for now (except in case of acute ON). The interventional nature of the study remains minimal

Primary outcome measures

  • Optic nerve involvement defined by occurrence of a recent clinical episode of ON [Time frame: assessed at baseline]
  • Asymptomatic optic nerve involvement defined by MRI (detection of an optic nerve T2 hypersignal) [Time frame: assessed at baseline]
  • Risk of a new clinical relapse will be assessed by the occurrence and time to onset of a second MS clinical relapse [Time frame: assessed every 6 months during 24 months]
  • Asymptomatic optic nerve involvement defined by OCT (GCIPL-IETD,3pm) [Time frame: assessed at baseline]
  • Risk of a new clinical relapse will be assessed by the occurrence and time to onset of a CDMS [Time frame: assessed every 6 months during 24 months]
Secondary outcome measures (2)
  • 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 [Time frame: assessed at baseline every 6 months during 24 months]
  • Time to the second clinical relapse occurrence will be assessed every 6 months during 24 months at each neurological examination [Time frame: assessed at Month 0, Month 6, Month 12, Month 18, Month 24]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

France · 1 center
  • Hôpital Roger Salengro — Lille

Identifiers

NCT: NCT06455332 · 2021_0474

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗