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Search / Trial NCT06455332

Predictive Value of the Optic Nerve Involvement in Clinically Isolated Syndrome

Launched by UNIVERSITY HOSPITAL, LILLE · Jun 6, 2024

Trial Information

Current as of July 22, 2025

Not yet recruiting

Keywords

Clinically Isolated Syndrome Multiple Sclerosis Mri Optical Coherence Tomography Optic Nerve Diagnostic Criteria

ClinConnect Summary

This clinical trial is studying the role of the optic nerve in patients who have experienced Clinically Isolated Syndrome (CIS), which can be an early sign of Multiple Sclerosis (MS). Specifically, the researchers want to see if changes in the optic nerve can help predict whether a person with CIS will go on to develop MS more definitively, as well as how long it may take for this to happen. Currently, optic nerve issues are not part of the standard criteria for diagnosing MS, even though they are common in these early stages.

To participate in this study, individuals must be between 18 and 55 years old and have had symptoms of CIS for six months or less. They also need to have specific MRI results that suggest MS. However, those with certain eye conditions, a history of MS, or who are pregnant or breastfeeding cannot join. While the study is not yet recruiting participants, those who take part can expect to undergo some tests, including MRIs, to assess their optic nerve and brain health. This research aims to improve how doctors diagnose and manage MS from the very beginning.

Gender

ALL

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

About University Hospital, Lille

University Hospital Lille is a leading academic medical institution dedicated to advancing healthcare through innovative clinical research and patient-centered care. As a prominent sponsor of clinical trials, the hospital leverages its extensive resources, multidisciplinary expertise, and state-of-the-art facilities to facilitate groundbreaking studies across various medical fields. Committed to enhancing therapeutic options and improving patient outcomes, University Hospital Lille collaborates with researchers, healthcare professionals, and industry partners to ensure rigorous scientific standards and ethical practices in all clinical trials.

Locations

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported