Visual (Path)Ways in Multiple Sclerosis - Part II

Not Applicable

Recruiting

• Conditions: Multiple Sclerosis, Optic Neuritis, Demyelinating Disease

• Registration Number: NCT06776224
• Lead Sponsor: University Hospital, Lille

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-09
• Study First Submitted QC: 2025-01-09
• Study First Posted: 2025-01-15
• Study Start: 2025-01-24
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-31
• Primary Completion: 2026-04-24
• Study Completion: 2026-04-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Quantifying progressive retinal axonal loss in the absence of inflammation	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)

Trial Locations

Locations (1)

Direction de la Recherche et de l'innovation (DRI) 6 rue Professeur Laguesse; 🇫🇷 Lille, France