NCT05487989 VIsual Pathways Model in Neuro-inflammatory Disorders
| NCT ID | NCT05487989 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Lille |
| Condition | Optic Neuritis |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2022-10-07 |
| Primary Completion | 2027-04-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2022-10-07 with a primary completion date of 2027-04-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
In neuroinflammatory diseases of the central nervous system (CNS) such as multiple sclerosis (MS), neuromyelitis optica spectrum disorders (NMOSD) and anti-MOG antibody-associated disorders (MOGAD), neuronal degeneration is the consequence of inflammatory and demyelinating lesions in the brain, optic nerve and spinal cord. Both white and grey matter are systematically affected. Lesions of the perivascular spaces containing cerebrospinal fluid (CSF) and meningeal inflammation seem to play an important role in the pathophysiology of these neuroinflammatory diseases. Currently, the interrelation of all these aspects is not clearly established in the pathophysiology of these diseases. In order to better understand the mechanisms that lead to and underlie the clinical disability of patients with these diseases, we need in vivo study models that allow the in-depth study of the neurodegenerative process and the identification of its causes. In this perspective, we make the hypothesis that the visual pathways model is very relevant to measure neuro-axonal loss and to explore the different mechanisms involved in neurodegeneration during MS and other CNS demyelinating diseases. Researchers have at their disposal many tools that allow them to analyse and quantify the neurodegenerative process in a reproducible and very precise manner from a structural and functional point of view, while taking into account possible vascular involvement (MRI, optical coherence tomography - angiography, etc…).
Eligibility Criteria
Inclusion Criteria: * \- Male or female * Aged between 18 and 65 years * Presenting a clinical picture of optic neuritis for less than 4 weeks, confirmed by neuro-ophthalmological assessment * Patient having given written consent to participate in the study * Patient with social insurance * Patient willing to comply with all study procedures and duration Exclusion Criteria: * \- history of optic neuritis on the same side as the recent episode for which the patient is being treated * history of retinal pathology (retinal detachment, glaucoma, retinopathies, retinal surgery) * diabetes * chronic alcohol intoxication * contraindications to MRI * pregnant women * persons under protective supervision (ex : guardianship) * minors * persons deprived of their liberty * administrative reasons: inability to receive informed information, inability to participate in the entire study, lack of social security coverage, refusal to sign consent A history of pre-existing CNS inflammatory demyelinating disease is not a criterion for non-inclusion.
Contact & Investigator
Olivier OUTTERYCK, MD
PRINCIPAL INVESTIGATOR
University Hospital, Lille
Frequently Asked Questions
Who can join the NCT05487989 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Optic Neuritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05487989 currently recruiting?
Yes, NCT05487989 is actively recruiting participants. Contact the research team at olivier.outteryck@chu-lille.fr for enrollment information.
Where is the NCT05487989 trial being conducted?
This trial is being conducted at Lille, France.
Who is sponsoring the NCT05487989 clinical trial?
NCT05487989 is sponsored by University Hospital, Lille. The principal investigator is Olivier OUTTERYCK, MD at University Hospital, Lille. The trial plans to enroll 100 participants.