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Visual (Path)Ways in Multiple Sclerosis - Part II

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06776224
Acronym
VWIMS - II
Enrollment
64
Registered
2025-01-15
Start date
2025-01-24
Completion date
2026-04-24
Last updated
2026-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis, Optic Neuritis, Demyelinating Disease

Keywords

Multiple sclerosis, cognition, OCT, MRI, visual impairment

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.

Interventions

OTHERMeasurement 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)

Sponsors

University Hospital, Lille
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Quantifying progressive retinal axonal loss in the absence of inflammationFirst time point already done (VWIMS study) Second time point during VWIMS -II study. Interval between time points will be around 7-8 yearsTo 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)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 16, 2026