VIsual Pathways Model in Neuro-inflammatory Disorders

Optic Neuritis Clinical Trial

— VIP-MODEL  

Official title:

Study of the VIsual Pathways MODEL for a Better Understanding of Neurodegeneration in Inflammatory and Demyelinating Disorders of Central Nervous System

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05487989
• Other study ID #: 2022_0289
• Secondary ID: 2022-A01483-40
• Status: Recruiting
• Start date: October 7, 2022
• Est. completion date: November 2025

Study information

• Verified date: December 2022
• Source: University Hospital, Lille
• Contact: Olivier OUTTERYCK, MD
• Phone: 0320445962
• Email: olivier.outteryck[@]chu-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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…).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neuritis
• Optic Neuritis

Intervention

Other:
• Clinical examen
MRI sequences for research, pupillometry, OCT-angiography, evaluation of visual cognition

Locations

Country	Name	City	State
France	Hop Fontan Chu	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Low contrast monocular visual acuity (2.5%, LogMAR unit) at distance from acute optic neuritis		at 12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Low contrast monocular visual acuity (2.5%, LogMAR unit) measured at 12 months (V5)		at inclusion and at 12 months follow-up
Secondary	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
Secondary	Optic nerve lesion length assessed at inclusion (V0)		at inclusion
Secondary	mGCIPL atrophy/retinal vascular alteration are assessed by mGCIPL volume/retinal vessel density difference between inclusion (V0) and at 12 months (V5).		at inclusion and at 12 months follow-up
Secondary	Presence of leptomeningeal cerebral enhancement		at inclusion, at 6 months and at 12 months follow-up
Secondary	T2 lesions brain and spinal cord volumes		at inclusion, at 6 months and at 12 months follow-up
Secondary	Brain grey matter volumes and brain perfusion (3D-ASL)		at inclusion, at 6 months and at 12 months follow-up