Clinical trial NCT06776224: Visual (Path)Ways in Multiple Sclerosis - Part II
Official title: Evaluation of Neuroaxonal Loss Outside of Any Inflammation in Multiple Sclerosis by a Multimodal Study of the Visual Pathways Model
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis, Optic Neuritis, Demyelinating Disease
Keywords: Multiple sclerosis, cognition, OCT, MRI, visual impairment
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2025-01-15
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Quantifying progressive retinal axonal loss in the absence of inflammation
timeFrame: First time point already done (VWIMS study) Second time point during VWIMS -II study. Interval between time points will be around 7-8 years
Secondary outcomes:
Other outcomes:
Locations:
city: Lille
country: France
facility: Direction de la Recherche et de l'innovation (DRI) 6 rue Professeur Laguesse
Study officials:
References: