Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
NCT05622643

OFSEP Very High Definition Cohort

Led by EDMUS Foundation · Updated on 2024-02-20

300

Participants Needed

5

Research Sites

206 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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))

CONDITIONS

Official Title

OFSEP Very High Definition Cohort

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient is already included in the OFSEP High Definition cohort (NCT03603457).
  • Patient has given informed and signed consent to join the VHD cohort.
  • Patient is insured or a beneficiary of a health insurance plan.
  • Healthy subjects must be older than 18 years.
  • Healthy subjects have given informed and signed consent for inclusion in the VHD cohort.
  • Healthy subjects are insured or beneficiaries of a health insurance plan.
Not Eligible

You will not qualify if you...

  • Patient is under judicial protection.
  • Patient refuses to sign consent.
  • Patient cannot be properly informed due to language or comprehension issues.
  • Patient had a relapse in the past 3 months.
  • Patient is pregnant or breastfeeding (MRI contraindicated).
  • Patient has MRI contraindications such as pacemaker, ferromagnetic vascular clip, infusion pump, neurostimulator, cochlear implants, or suspected metallic foreign body.
  • Patient has severe psychiatric illness.
  • Patient has severe chronic alcoholism.
  • Healthy subjects with any history of disease affecting the central nervous system.
  • Healthy subjects with a family history of multiple sclerosis.

AI-Screening

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Trial Site Locations

Total: 5 locations

1

CHU de Lyon

Lyon, France

Not Yet Recruiting

2

CHU de Nancy

Nancy, France

Not Yet Recruiting

3

CHU de Nîmes

Nîmes, France

Not Yet Recruiting

4

CHU de Rennes

Rennes, France

Actively Recruiting

5

CHU de Strasbourg

Strasbourg, France

Not Yet Recruiting

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Research Team

A

Anne Kerbrat, Dr

CONTACT

E

Eric Thouvenot, Pr.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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