Image

OFSEP Very High Definition Cohort

Recruiting
18 years of age
Both
Phase N/A

Powered by AI

Overview

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

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 in the VHD cohort.
    • The patient must be insured or beneficiary of a health insurance plan.
  • 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 the study, 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, ferromagnetic vascular clip, infusion pump, neurostimulator, cochlear implants or in whom there is 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 the inclusion 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 understand the study, language problem).
    • The healthy subject is pregnant or breast-feeding (MRI contraindicated).
    • The healthy subject has MRI contra-indications (a pacemaker, ferromagnetic vascular clip, infusion pump, neurostimulator, cochlear implants or in whom there is a suspicion of a metallic foreign body).
    • The healthy subject has a history of disease that may affect the central nervous system.
    • The healthy subject has a family history of MS.

Study details

Multiple Sclerosis

NCT05622643

EDMUS Foundation

25 January 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.