Clinical trial NCT05487989: VIsual Pathways Model in Neuro-inflammatory Disorders
Official title: Study of the VIsual Pathways MODEL for a Better Understanding of Neurodegeneration in Inflammatory and Demyelinating Disorders of Central Nervous System
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Optic Neuritis
Keywords: Optic neuritis
Optical coherence tomography, MRI, demyelination, neuro-axonal loss.
MRI
demyelination
neuro-axonal loss
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2022-08-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Primary outcomes:
measure: Presence of enhancement of the optic nerve sheath on the axial T1 dixon MRI sequence post gadolinium at the acute phase of optic neuritis.
timeFrame: at inclusion
measure: Low contrast monocular visual acuity (2.5%, LogMAR unit) at distance from acute optic neuritis
timeFrame: at 12 months
Secondary outcomes:
measure: 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.
timeFrame: at inclusion and at 12 months follow-up
measure: Optic nerve lesion length on 3D-DIR sequence. Alteration of retinal microvascularisation between inclusion and the maximal follow-up.
timeFrame: at inclusion and at 12 months follow-up
measure: Acute alteration of retinal microvascularisation is assessed by the difference of retinal vascular density between inclusion (V0) and one month later (V1).
timeFrame: at inclusion and at 1 months follow-up
measure: Low contrast monocular visual acuity (2.5%, LogMAR unit) measured at 12 months (V5)
timeFrame: at inclusion and at 12 months follow-up
measure: Amplitude of the melanopsin-mediated sustained constriction phase in the blue light-induced pupillary response is assessed at 12 months (V5).
timeFrame: at inclusion and at 12 months follow-up
measure: Optic nerve lesion length assessed at inclusion (V0)
timeFrame: at inclusion
measure: mGCIPL atrophy/retinal vascular alteration are assessed by mGCIPL volume/retinal vessel density difference between inclusion (V0) and at 12 months (V5).
timeFrame: at inclusion and at 12 months follow-up
measure: Presence of leptomeningeal cerebral enhancement
timeFrame: at inclusion, at 6 months and at 12 months follow-up
measure: T2 lesions brain and spinal cord volumes
timeFrame: at inclusion, at 6 months and at 12 months follow-up
measure: Brain grey matter volumes and brain perfusion (3D-ASL)
timeFrame: at inclusion, at 6 months and at 12 months follow-up
Other outcomes:
Locations:
city: Lille
country: France
facility: Hop Fontan Chu
Study officials:
affiliation: University Hospital, Lille
name: Olivier OUTTERYCK, MD
role: PRINCIPAL_INVESTIGATOR
References: