VIsual Pathways Model in Neuro-inflammatory Disorders

NCT05487989 | Recruiting

• 2 other identifiers: 2022_02892022-A01483-40
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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…).

Conditions

Optic Neuritis

Keywords

Optic neuritis; Optical coherence tomography, MRI, demyelination, neuro-axonal loss.; MRI; demyelination; neuro-axonal loss

Outcome Measures

Primary Outcomes (2)

• Presence of enhancement of the optic nerve sheath on the axial T1 dixon MRI sequence post gadolinium at the acute phase of optic neuritis.

  at inclusion

• Low contrast monocular visual acuity (2.5%, LogMAR unit) at distance from acute optic neuritis

  at 12 months

Secondary Outcomes (10)

• Presence of enhancement of the optic nerve sheath on the axial T1 dixon MRI sequence post gadolinium. Macular GCIPL atrophy will be assessed by the variation of mGCIPL volume between inclusion and the maximal follow-up.

  at inclusion and at 12 months follow-up

• Optic nerve lesion length on 3D-DIR sequence. Alteration of retinal microvascularisation between inclusion and the maximal follow-up.

  at inclusion and at 12 months follow-up

• Acute alteration of retinal microvascularisation is assessed by the difference of retinal vascular density between inclusion (V0) and one month later (V1).

  at inclusion and at 1 months follow-up

• Low contrast monocular visual acuity (2.5%, LogMAR unit) measured at 12 months (V5)

  at inclusion and at 12 months follow-up

• Amplitude of the melanopsin-mediated sustained constriction phase in the blue light-induced pupillary response is assessed at 12 months (V5).

  at inclusion and at 12 months follow-up

Study Arms (1)

optic neuritis patients

Patients suffering from an acute episode of optic neuritis will be included. There will be only one group of patients prospectively followed-up.

Other: Clinical examen

Interventions

Clinical examen OTHER

MRI sequences for research, pupillometry, OCT-angiography, evaluation of visual cognition

optic neuritis patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting an episode of acute optic neuritis with the objective of better understanding the pathophysiology of CNS inflammatory diseases and identifying prognostic biomarkers in imaging

You may qualify if:

• \- 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hop Fontan Chu

Lille, 59037, France

RECRUITING

MeSH Terms

Conditions

Optic Neuritis; Demyelinating Diseases

Condition Hierarchy (Ancestors)

Optic Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases

Study Officials

• Olivier OUTTERYCK, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olivier OUTTERYCK, MD

CONTACT

0320445962; olivier.outteryck@chu-lille.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: August 4, 2022
• Study Start: October 7, 2022
• Primary Completion (Estimated): April 7, 2027
• Study Completion (Estimated): April 7, 2028
• Last Updated: August 20, 2025

Record last verified: 2025-08

Locations

FR (1)