Grey Matter Damage at the Earliest Phase of Multiple Sclerosis : a Longitudinal 7T MRI Study (MSGM7T)
Primary Purpose
Multiple Sclerosis
Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI 7T
Sponsored by
About this trial
This is an interventional diagnostic trial for Multiple Sclerosis
Eligibility Criteria
Inclusion Criteria:
- First presumed inflammatory demyelinating event in the central nervous system involving either the optic nerve, the spinal cord, a brain hemisphere, or the brainstem without spatial and time dissemination criteria
- Oligoclonal bands on CSF analysis
- Age between 18 and 45
- No previous history of neurological symptoms suggestive of demyelination
- No steroids in the month before MRI
- First MRI within six months after the first clinical episode
Exclusion Criteria:
- Possible alternative diagnoses
- Previous history of neurological or psychiatric disease
- Previous administration of immunosuppressive drugs
- Pregnancy
- Patient unable to give his consent for the study or patient under tutorship
Sites / Locations
- Assistance Publique Des Hopitaux de Marseille
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MS Patients
Arm Description
Multiple sclerosis patients MRI 7T will be performed
Outcomes
Primary Outcome Measures
number of cortical lesions
Cortical lesion detection on 7T MRI at baseline
Secondary Outcome Measures
Full Information
NCT ID
NCT03659981
First Posted
September 4, 2018
Last Updated
July 20, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT03659981
Brief Title
Grey Matter Damage at the Earliest Phase of Multiple Sclerosis : a Longitudinal 7T MRI Study
Acronym
MSGM7T
Official Title
Grey Matter Damage at the Earliest Phase of Multiple Sclerosis : a Longitudinal 7T Magnetic Resonance Imaging Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 20, 2018 (Actual)
Primary Completion Date
May 19, 2022 (Actual)
Study Completion Date
May 18, 2024 (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
The present study is an opportunity to assess grey matter damage at the earliest phase of Multiple Sclerosis (MS) allowing to a better understanding of its origins and its impact and disease severity. This study is a preliminary longitudinal study to precisely depict the kinetic of grey matter damage and the links with disease aggravation. Thirty MS patients without time and spatial dissemination criteria (only one symptomatic MRI lesion detected) but with oligoclonal bands detected on cerebro spinal fluid analysis will be included for a monocentric transversal MRI study at 7T to assess grey matter injury. Clinical and neuropsychological assessments will be performed in the population the same day of a multi-parametric MRI. A longitudinal clinical and MRI follow up will be performed during 2 years.
Detailed Description
The present study is an opportunity to assess grey matter damage at the earliest phase of MS allowing to a better understanding of its origins and its impact and disease severity. This study is a preliminary longitudinal study to precisely depict the kinetic of grey matter damage and the links with disease aggravation. Thirty MS patients without time and spatial dissemination criteria (only one symptomatic MRI lesion detected) but with oligoclonal bands detected on cerebro spinal fluid analysis will be included for a monocentric transversal MRI study at 7T to assess grey matter injury. Clinical and neuropsychological assessments will be performed in the population the same day of a multi-parametric MRI. A longitudinal clinical and MRI follow up will be performed during 2 years.
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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MS Patients
Arm Type
Experimental
Arm Description
Multiple sclerosis patients MRI 7T will be performed
Intervention Type
Other
Intervention Name(s)
MRI 7T
Intervention Description
The imaging parameters will come from the 7 Tesla Siemens MRI
Primary Outcome Measure Information:
Title
number of cortical lesions
Description
Cortical lesion detection on 7T MRI at baseline
Time Frame
2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
First presumed inflammatory demyelinating event in the central nervous system involving either the optic nerve, the spinal cord, a brain hemisphere, or the brainstem without spatial and time dissemination criteria
Oligoclonal bands on CSF analysis
Age between 18 and 45
No previous history of neurological symptoms suggestive of demyelination
No steroids in the month before MRI
First MRI within six months after the first clinical episode
Exclusion Criteria:
Possible alternative diagnoses
Previous history of neurological or psychiatric disease
Previous administration of immunosuppressive drugs
Pregnancy
Patient unable to give his consent for the study or patient under tutorship
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
EMILIE GARRIDO PRADALIE
Organizational Affiliation
APHM
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Des Hopitaux de Marseille
City
Marseille
State/Province
Paca
ZIP/Postal Code
13354
Country
France
12. IPD Sharing Statement
Learn more about this trial
Grey Matter Damage at the Earliest Phase of Multiple Sclerosis : a Longitudinal 7T MRI Study
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