MRI Study of the Mechanisms Underlying Irreversible Disability in Multiple Sclerosis (SEP-MRI)

Magnetic Resonance Imaging Study of the Mechanisms Underlying Irreversible Disability in Multiple Sclerosis

Multiple sclerosis (MS) is the first non-traumatic cause of disability in young people, responsible for physical but also cognitive deficits. MS is an inflammatory demyelinating and degenerative disease of the central nervous system. Recently, MRI technics have demonstrated their sensibility to the different processes involved in MS. Particularly, MRI has evidenced that the pathological process of MS is not restricted to the macroscopic lesions of the white matter but also involves the normal appearing white and grey matter. In the normal appearing brain tissue, demyelination, neuronal suffering and neuronal loss have been evidenced. Moreover, MRI has demonstrated the existence of brain functional reorganization processes that may limit the clinical expression of pathological injuries. Despite these important findings, the pathological underpinnings of irreversible disability are largely unknown. The present project aims to depict the main determinants of physical but also cognitive disability in patients with MS. To do this, a longitudinal study including 70 patients with MS using different MRI markers known to be sensitive to the different pathological aspects of MS will be performed. The relationships between these markers and the progression of disability will be assessed. Identification of the main pathological underpinnings of irreversible disability of MS will provide the most relevant therapeutic targets.

Study Overview

• Status: Active, not recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: MRI 3T; Other: MRI 1,5T; Other: MRI 7T

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13005
    • Assistance Publique - Hopitaux de Marseille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Major patient,
• Patient affiliated to a health insurance plan
• Patient having signed free and informed consent after receiving detailed, understandable and honest information,
• Patient with multiple sclerosis according to the criteria of Polman 2010

Exclusion Criteria:

• Patients with the usual contraindications to MRI (pace-maker, agitation, metal splinters, claustrophobia etc.)
• Patients at risk of non-compliance on examination: impaired understanding, confusion, involuntary movements, poor tolerance of prolonged supine
• Patients with known allergy to gadolinium
• Patients with renal insufficiency
• Patients unable to give their consent: disorders of the comprehension, disturbances of vigilance, confusion ...
• Pregnant and breastfeeding woman
• Patients with a history of neurological or psychiatric pathology
• Patients under guardianship or curatorship

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Principal study; Patients pathological process will be assessed using MRI 3T	Other: MRI 3T; Magnetic Resonance Imaging 3 Tesla
Experimental: Ancillary study 1; Patients pathological process will be assessed using MRI 1,5T	Other: MRI 1,5T; Magnetic Resonance Imaging 1,5 Tesla
Experimental: Ancillary study 2; Patients pathological process will be assessed using MRI 7T	Other: MRI 7T; Magnetic Resonance Imaging 7 Tesla

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Measurement of the Expanded Disability Status Scale (EDSS) value (score from 0 to 20) constituing the actual international reference scale to measure the level of disability caused by parkinson disease	5 years

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille
• Investigators: Study Director: Jean-Olivier ARNAUD, Assistance Publique - Hopitaux de Marseille

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2017
• Primary Completion (Actual): January 16, 2023
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: November 6, 2017
• First Submitted That Met QC Criteria: November 28, 2017
• First Posted (Actual): November 29, 2017

Study Record Updates

• Last Update Posted (Actual): August 6, 2024
• Last Update Submitted That Met QC Criteria: August 5, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 2016-52; 2017-A00136-47 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No