Visual (Path)Ways in Multiple Sclerosis - Part II (VWIMS - II)

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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis, Optic Neuritis, Demyelinating Disease
• Intervention / Treatment: Other: Measurement of retinal vascular density and visual cognition

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lille, France, 59037
    • Direction de la Recherche et de l'innovation (DRI) 6 rue Professeur Laguesse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Not applicable. No treatment will be compared.; During the same visit, we will perform OCT-angiography (10 minutes) and evaluate visual cognition with an eye-tracker (20 minutes)	Other: Measurement of retinal vascular density and visual cognition; During the same visit, we will perform OCT-angiography (10 minutes) and evaluate visual cognition with an eye-tracker (20 minutes)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantifying progressive retinal axonal loss in the absence of inflammation	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)	First time point already done (VWIMS study) Second time point during VWIMS -II study. Interval between time points will be around 7-8 years

Collaborators and Investigators

• Sponsor: University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2025
• Primary Completion (Actual): April 24, 2026
• Study Completion (Actual): April 24, 2026

Study Registration Dates

• First Submitted: January 9, 2025
• First Submitted That Met QC Criteria: January 9, 2025
• First Posted (Actual): January 15, 2025

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Multiple sclerosis, cognition, OCT, MRI, visual impairment
• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Eye Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Sensation Disorders; Genetic Diseases, X-Linked; Optic Nerve Diseases; Cranial Nerve Diseases; Brain Diseases, Metabolic, Inborn; Brain Diseases, Metabolic; Amino Acid Metabolism, Inborn Errors; Urea Cycle Disorders, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Multiple Sclerosis; Ornithine Carbamoyltransferase Deficiency Disease; Demyelinating Diseases; Vision Disorders; Optic Neuritis
• Other Study ID Numbers: 2024_0018; 2024-A01517-40 (Other Identifier: IDRCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No