Visual (Path)Ways in Multiple Sclerosis - Part II

NCT ID: NCT06776224

Last Updated: 2025-01-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-24
• Study Completion Date: 2026-04-24

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.

Conditions

Multiple Sclerosis, Optic Neuritis, Demyelinating Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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)

Group Type: OTHER

Measurement of retinal vascular density and visual cognition

Intervention Type: OTHER

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

Interventions

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)

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Direction de la Recherche et de l'innovation (DRI) 6 rue Professeur Laguesse

Lille, , France

Site Status: RECRUITING

Countries

France

Central Contacts

OUTTERYCK Olivier, PhD

Role: CONTACT

olivier.outteryck@chru-lille.fr

03.20.44.64.69 ext. +33

COURTOIS Brigitte

Role: CONTACT

DRS.PROMOTION@CHU-LILLE.FR

03.20.44.41.45 ext. +33

Facility Contacts

Secrétariat Promotion NA

Role: primary

DRS.PROMOTION@CHU-LILLE.FR

03.20.44.41.45 ext. +33

Other Identifiers

2024-A01517-40

Identifier Type: OTHER

Identifier Source: secondary_id

2024_0018

Identifier Type: -

Identifier Source: org_study_id