MRI Study of the Mechanisms Underlying Irreversible Disability in Multiple Sclerosis

NCT03356366 | Active Not Recruiting

• 2 other identifiers: 2016-522017-A00136-47
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Principal study

EXPERIMENTAL

Patients pathological process will be assessed using MRI 3T

Other: MRI 3T

Ancillary study 1

EXPERIMENTAL

Patients pathological process will be assessed using MRI 1,5T

Other: MRI 1,5T

Ancillary study 2

EXPERIMENTAL

Patients pathological process will be assessed using MRI 7T

Other: MRI 7T

Interventions

MRI 3T OTHER

Magnetic Resonance Imaging 3 Tesla

Principal study

MRI 1,5T OTHER

Magnetic Resonance Imaging 1,5 Tesla

Ancillary study 1

MRI 7T OTHER

Magnetic Resonance Imaging 7 Tesla

Ancillary study 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique - Hôpitaux de Marseille

Marseille, 13005, France

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Jean-Olivier ARNAUD

  Assistance Publique - Hôpitaux de Marseille

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2017
• First Posted: November 29, 2017
• Study Start: October 2, 2017
• Primary Completion: January 16, 2023
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 6, 2024

Record last verified: 2024-08

Locations

FR (1)