VIsual Pathways Model in Neuro-inflammatory Disorders

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorUniversity Hospital, Lille

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

- 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

Disqualifiers

- 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

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Clinical examen

    Other intervention

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

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: optic neuritis patients1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

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