Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05487989

VIsual Pathways Model in Neuro-inflammatory Disorders

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…).

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Optic Neuritis Cranial Nerve Diseases Demyelinating Diseases Eye Diseases Nervous System Diseases Optic Nerve Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hop Fontan Chu

Lille, 59037, France

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clinical examen

Other

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

Primary outcomes

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

    Time frame: at inclusion

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

    Time frame: at 12 months

Secondary outcomes

  1. 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.

    Time frame: at inclusion and at 12 months follow-up

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

    Time frame: at inclusion and at 12 months follow-up

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

    Time frame: at inclusion and at 1 months follow-up

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

    Time frame: at inclusion and at 12 months follow-up

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

    Time frame: at inclusion and at 12 months follow-up

  6. Optic nerve lesion length assessed at inclusion (V0)

    Time frame: at inclusion

  7. mGCIPL atrophy/retinal vascular alteration are assessed by mGCIPL volume/retinal vessel density difference between inclusion (V0) and at 12 months (V5).

    Time frame: at inclusion and at 12 months follow-up

  8. Presence of leptomeningeal cerebral enhancement

    Time frame: at inclusion, at 6 months and at 12 months follow-up

  9. T2 lesions brain and spinal cord volumes

    Time frame: at inclusion, at 6 months and at 12 months follow-up

  10. Brain grey matter volumes and brain perfusion (3D-ASL)

    Time frame: at inclusion, at 6 months and at 12 months follow-up

Study contacts

Contact information is provided by the study sponsor or research team.

Olivier OUTTERYCK, MD

CONTACT

[email protected]

0320445962 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Acronym: VIP-MODEL

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
Aug 4, 2022
Registry last updated
Aug 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.