Mechanisms of Disease Severity in Multiple Sclerosis: an Integrative Multimodal Study

Overview

This study will identify a combination of disease severity markers (genetic, immunology, epigenetic, imaging) associated with disease severity and progression in a cohort of patients with multiple sclerosis.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 15, 2020

Detailed Description

The heterogeneity of multiple sclerosis evolution relies on several pathophysiological mechanisms including neuroinflammation, neurodegeneration and remyelination and repair mechanisms. The study will identify markers of disease severity in a longitudinal cohort of patients with multiple sclerosis who are siblings (both siblings having multiple sclerosis) including: biological markers (genetic, immunological and epigenetic markers, advanced MRI markers). An integrative model to predict disease progression will be proposed based on multimodal markers.

Interventions

  • Other: Composite severity score calculation
    • Neurological examination, cognitive testing, and MRI exam

Arms, Groups and Cohorts

  • Multiple Sclerosis siblings
    • Group of siblings having multiple sclerosis, n=120 Composite severity score calculation for all subjects

Clinical Trial Outcome Measures

Primary Measures

  • Change of Expanded disability status scale
    • Time Frame: Baseline and 18 months
    • Change in the neurological assessment of disability related to multiple sclerosis

Secondary Measures

  • Change in neuropsychological scores
    • Time Frame: Baseline and 18 months
    • Change in the battery of neuropsychological tests adapted for multiple sclerosis
  • Change in T2 lesion volume
    • Time Frame: Baseline and 18 months
    • Change in volume of T2 lesion in the white matter
  • Grey matter volume change
    • Time Frame: Baseline and 18 months
    • Change in cerebral grey matter volume

Participating in This Clinical Trial

Inclusion Criteria

  • Clinically isolated syndrome or Multiple sclerosis (2010 Mc Donald criteria) – Sibling having Clinically isolated syndrome or Multiple sclerosis (2010 Mc Donald criteria) willing to participate to the study – Affiliated to the French social security or equivalent Exclusion Criteria:

  • Cyclophosphamide, mitoxantrone or methylprednisolone infusion within one month before inclusion – Multiple sclerosis relapse within one month before inclusion – Concomittant severe or uncontrolled disease

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Institut National de la Santé Et de la Recherche Médicale, France
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Céline Louapre, MD, PhD, Principal Investigator, Institut du Cerveau et de la Moelle Epinière
  • Overall Contact(s)
    • Céline Louapre, MD, PhD, +33 1 42 16 57 66, celine.louapre@aphp.fr

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