Visual (Path)Ways in Multiple Sclerosis - Part II

Multiple sclerosis (MS) is an inflammatory demyelinating and degenerative disease of the central nervous system. The mechanisms of neuro-axonal loss remain incompletely elucidated. An acute demyelinating lesion will produce both immediate and delayed axonal loss. Immediate axonal loss is linked to the occurrence of axonal transection. Delayed axonal loss is the cause of axonal degeneration in progressive MS. Visual impairment is common in the disease (vision, oculomotricity, cognition). Through a longitudinal multimodal analysis of visual pathways, we would like to investigate physiopathological mechanisms leading to neurodegenerative process and visual impairment.

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Key information

Conditions

Multiple Sclerosis, Optic Neuritis, Demyelinating Disease Amino Acid Metabolism, Inborn Errors Autoimmune Diseases Autoimmune Diseases of the Nervous System Brain Diseases Brain Diseases, Metabolic Brain Diseases, Metabolic, Inborn Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cranial Nerve Diseases Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Eye Diseases Genetic Diseases, Inborn Genetic Diseases, X-Linked Immune System Diseases Metabolic Diseases Metabolism, Inborn Errors Multiple Sclerosis Nervous System Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Optic Nerve Diseases Optic Neuritis Ornithine Carbamoyltransferase Deficiency Disease Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Urea Cycle Disorders, Inborn Vision Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Direction de la Recherche et de l'innovation (DRI) 6 rue Professeur Laguesse

Lille, 59037, France

Who can participate

Healthy volunteers accepted: No

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

Patients with relapsing-remitting multiple sclerosis receiving high-efficacy or non-high-efficacy treatment and follow-up at the CRCSEP of the Lille University Hospital through past participation in the VWIMS study.

Inclusion criteria

Male and/or female participants in the VWIMS research project
At least 18 years of age at the time of inclusion in VWIMS - II
Patient having given written consent to participate in the study
Socially insured patient
Patient willing to comply with all study procedures and duration

Exclusion criteria

Age < 18 years
Other neurological pathologies that may interfere with MRI and/or OCT data (diabetes, retinopathy [any cause], glaucoma, retinal detachment, ametropia > 6 diopters)
Contraindications to MRI (claustrophobia, incompatible metal foreign bodies such as certain pacemakers and mechanical valves, cochlear implants, intra-orbital metal splinters, pregnancy, certain brands of IUD because of the 3 Tesla magnetic field).
Contraindication to injection: severe renal failure with creatine clearance <30, allergy to contrast media, pregnancy, breast-feeding.
Pregnant women
Nursing women
Persons incapable of giving consent on their own, with or without legal protection (guardianship/curatorship)
Person under legal protection
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 form

Treatment and study plan

Measurement of retinal vascular density and visual cognition

Other

During the same visit, we will perform OCT-angiography (10 minutes) and evaluate visual cognition with an eye-tracker (20 minutes)

Primary outcomes

Quantifying progressive retinal axonal loss in the absence of inflammation

Time frame: First time point already done (VWIMS study) Second time point during VWIMS -II study. Interval between time points will be around 7-8 years

To quantify progressive retinal neuroaxonal loss in a context of no active inflammation : Difference in retinal atrophy (GCIPL volume in [VWIMS I] - GCIPL volume in VWIMS II)

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

Evaluation of Neuroaxonal Loss Outside of Any Inflammation in Multiple Sclerosis by a Multimodal Study of the Visual Pathways Model

Acronym: VWIMS - II

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Jan 15, 2025
Registry last updated: May 15, 2026

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.

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

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