OFSEP Very High Definition Cohort

Last updated: February 15, 2024
Sponsor: EDMUS Foundation
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neurologic Disorders

Multiple Sclerosis

Memory Loss

Treatment

MRI

Clinical Study ID

NCT05622643
004
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Multiple sclerosis (MS) is the most common acquired neurological disease leading to disability in young adults. MS often leads to the development of a physical and/or cognitive impairment that disables patients in their daily lives. Early use of disease modifying treatments for patients at risk of developing disability is therefore essential.

However, disability progression is very heterogeneous between patients and currently impossible to predict at the individual level. Thus, numerous studies, particularly epidemiological and imaging studies, have identified prognostic factors for the development of disability such as age, gender, number of relapses during the first years of the disease, existence of a residual disability after a first relapse, number of gadolinium-enhancing lesions on initial MRI, early brainstem and spinal cord lesions. However, these different factors only explain incompletely the progression of the physical or cognitive disability in MS patients. In particular, some components of MS pathophysiology, more related to the progressive development of disability, such as axonal degeneration or the existence of chronic inflammation of the central nervous system (CNS) are usually not measured by these biomarkers.

In this research project, the investigators will test promising biomarkers, focused on these components of the disease, on a large cohort of patients in a multicenter setting, in order to evaluate their added value to predict disability progression, in comparison with more classical biomarkers such as clinical characteristics, and brain and spinal cord lesion load.

In particular, the investigators will test:

  • Imaging biomarkers extracted from brain and spinal cord MP2RAGE, brain and spinal cord QSM, brain and spinal cord relaxometry, brain diffusion and spinal cord magnetization transfer sequences

  • Biomarkers extracted from optical coherence tomography (OCT)

  • Biological biomarkers (serum neurofilament-light chain (NFL) and Glial Fibrillary Acidic Protein (GFAP))

Eligibility Criteria

Inclusion

For MS patients:

  • Inclusion Criteria:
  • The patient must be already included in the OFSEP High Definition cohort (NCT03603457).
  • The patient must have given his informed and signed consent for the inclusion inthe VHD cohort.
  • The patient must be insured or beneficiary of a health insurance plan.

Exclusion

  • Exclusion Criteria:
  • The patient is under judicial protection.
  • The patient refuses to sign the consent.
  • It is impossible to correctly inform the patient (Inability to understand thestudy, language problem).
  • The patient has experienced a relapse in the previous 3 months.
  • The patient is pregnant or breast-feeding (MRI contraindicated).
  • Patient with MRI contra-indications (patient with a pacemaker, ferromagneticvascular clip, infusion pump, neurostimulator, cochlear implants or in whom thereis a suspicion of a metallic foreign body).
  • The patient has a severe psychiatric illness
  • The patient has severe chronic alcoholism For healthy subjects:
  • Inclusion Criteria:
  • The healthy subject must be older than 18 years
  • The healthy subject must have given his informed and signed consent for theinclusion in the VHD cohort.
  • The healthy subject must be insured or beneficiary of a health insurance plan.
  • Exclusion Criteria:
  • The healthy subject is under judicial protection.
  • It is impossible to correctly inform the healthy subject (Inability to understandthe study, language problem).
  • The healthy subject is pregnant or breast-feeding (MRI contraindicated).
  • The healthy subject has MRI contra-indications (a pacemaker, ferromagneticvascular clip, infusion pump, neurostimulator, cochlear implants or in whom thereis a suspicion of a metallic foreign body).
  • The healthy subject has a history of disease that may affect the central nervoussystem.
  • The healthy subject has a family history of MS.

Study Design

Total Participants: 300
Treatment Group(s): 1
Primary Treatment: MRI
Phase:
Study Start date:
January 19, 2023
Estimated Completion Date:
January 01, 2027

Connect with a study center

  • CHU de Lyon

    Lyon,
    France

    Site Not Available

  • CHU de Nancy

    Nancy,
    France

    Site Not Available

  • CHU de Nîmes

    Nîmes,
    France

    Site Not Available

  • CHU de Rennes

    Rennes,
    France

    Active - Recruiting

  • CHU de Strasbourg

    Strasbourg,
    France

    Site Not Available

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