MRI Study of the Mechanisms Underlying Irreversible Disability in Multiple Sclerosis (SEP-MRI)
Primary Purpose
Multiple Sclerosis
Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI 3T
MRI 1,5T
MRI 7T
Sponsored by
About this trial
This is an interventional diagnostic trial for Multiple Sclerosis
Eligibility Criteria
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
Sites / Locations
- Assistance Publique - Hôpitaux de Marseille
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Principal study
Ancillary study 1
Ancillary study 2
Arm Description
Patients pathological process will be assessed using MRI 3T
Patients pathological process will be assessed using MRI 1,5T
Patients pathological process will be assessed using MRI 7T
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT03356366
First Posted
November 6, 2017
Last Updated
July 19, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT03356366
Brief Title
MRI Study of the Mechanisms Underlying Irreversible Disability in Multiple Sclerosis
Acronym
SEP-MRI
Official Title
Magnetic Resonance Imaging Study of the Mechanisms Underlying Irreversible Disability in Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 2, 2017 (Actual)
Primary Completion Date
January 16, 2023 (Actual)
Study Completion Date
December 31, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Principal study
Arm Type
Experimental
Arm Description
Patients pathological process will be assessed using MRI 3T
Arm Title
Ancillary study 1
Arm Type
Experimental
Arm Description
Patients pathological process will be assessed using MRI 1,5T
Arm Title
Ancillary study 2
Arm Type
Experimental
Arm Description
Patients pathological process will be assessed using MRI 7T
Intervention Type
Other
Intervention Name(s)
MRI 3T
Intervention Description
Magnetic Resonance Imaging 3 Tesla
Intervention Type
Other
Intervention Name(s)
MRI 1,5T
Intervention Description
Magnetic Resonance Imaging 1,5 Tesla
Intervention Type
Other
Intervention Name(s)
MRI 7T
Intervention Description
Magnetic Resonance Imaging 7 Tesla
Primary Outcome Measure Information:
Title
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
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Olivier ARNAUD
Organizational Affiliation
Assistance Publique - Hôpitaux de Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique - Hôpitaux de Marseille
City
Marseille
ZIP/Postal Code
13005
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
MRI Study of the Mechanisms Underlying Irreversible Disability in Multiple Sclerosis
We'll reach out to this number within 24 hrs