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

University Hospital, Lille

Status: Enrolling

Conditions: Multiple Sclerosis, Optic Neuritis, Demyelinating Disease

Treatments: Other: Measurement of retinal vascular density and visual cognition

Study type: Interventional

Funder types: Other

Identifiers

NCT06776224

2024_0018

2024-A01517-40 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 64 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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64 participants in 1 patient group

Not applicable. No treatment will be compared.

Other group

Description:

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

Treatment:

Other: Measurement of retinal vascular density and visual cognition