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

NCT ID: NCT03369106

Last Updated: 2025-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-06

Study Completion Date

2026-02-05

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Multiple Sclerosis siblings

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

Composite severity score calculation

Intervention Type OTHER

Neurological examination, cognitive testing, and MRI exam

Interventions

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Composite severity score calculation

Neurological examination, cognitive testing, and MRI exam

Intervention Type OTHER

Eligibility Criteria

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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
* Concomitant severe or uncontrolled disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Céline Louapre, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Institut du Cerveau et de la Moelle Epinière

Locations

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CIC Neurosciences Institut du Cerveau et de la Moelle Epinière

Paris, , France

Site Status

Countries

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France

Other Identifiers

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2017-A01844-49

Identifier Type: REGISTRY

Identifier Source: secondary_id

C16-114

Identifier Type: -

Identifier Source: org_study_id

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