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Characterization of Cortical Injury in Early MS Patients: a 7T MRI Study

Primary Purpose

Multiple Sclerosis (MS)

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI 7T
TEST EDSS
TEST MSFC
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Multiple Sclerosis (MS)

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with relapsing-remitting MS (McDonald's criteria 2010) early (duration evolution <2 years),
  • Age between 18 and 45 years,
  • No history of neurological symptoms suggestive of demyelinating pathology,
  • No corticosteroids in the month preceding the completion of the MRI,
  • Realization of the MRI in the first 6 months following the inaugural clinical episod

Exclusion Criteria:

  • Argument for a differential diagnosis (systemic lupus erythematosus, antiphospholipid syndrome, Behçet's disease, sarcoidosis, Lyme disease, cerebral arteritis, lymphoma CNS, etc.),
  • History of neurological or psychiatric illness,
  • History of taking immunosuppressive drugs,
  • Claustrophobia
  • Pregnancy,
  • Patient unable or unwilling to give consent, patient under guardianship,
  • Patient not affiliated to a social security regime

Sites / Locations

  • Assistance Publique Hopitaux de Marseille

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

patient with multiple sclerosis (MS)

Arm Description

Outcomes

Primary Outcome Measures

visualization of cortical lesions
By IRM 7T

Secondary Outcome Measures

measure of physical disability
score EDSS
cognitive impairment index
score IAC

Full Information

First Posted
August 6, 2018
Last Updated
August 6, 2018
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT03624296
Brief Title
Characterization of Cortical Injury in Early MS Patients: a 7T MRI Study
Official Title
Characterization of Cortical Injury in Early MS Patients: a 7T MRI Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 2018 (Anticipated)
Primary Completion Date
October 2019 (Anticipated)
Study Completion Date
March 2020 (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 main aim of the present study is to assess the prevalence, the topography and the clinical counterpart of cortical lesions in patient included early after the first clinical episode of multiple sclerosis. A second aim is to assess the direct contribution of cortical lesions - independent of WM injury - on the diffuse grey matter damage. Thirty MS patients will be included in the six months after the first clinical episode of multiple sclerosis for a monocentric transversal MRI study at 7T to assess cortical MS injury. Clinical (EDSS) and neuropsychological assessments will be performed in the population the same day of a multi-parametric MRI. MRI protocol is designed to increase the detection rate of CL using multiple contrasts at high isotropic resolution (600µm3) on a whole brain exploration. Thus, MRI acquisition will include MP2RAGE, T2*, FLAIR and DIR as previously published but also recent MRI technique like FLAWS, focusing on the grey matter by attenuating the white matter and CSF signal. Finally, QSM sequences will be performed. QSM measures tissue magnetic susceptibility mostly influenced by iron, myelin and calcium content in the brain. Due to physical properties of the technique (bipolarity), we suppose that high resolution QSM will be more sensitive that previous used sequences to depict cortical lesions. Using this multi-contrast approach with relevant MRI sequence and with a high resolution whole brain exploration might improve the detection of CL in early MS. Furthermore, MRI protocol allow us to estimate neuronal loss (T1 relaxation time), myelin and iron content (QSM and T2* relaxation time) within and outside cortical lesions in GM. The present study is an opportunity to assess cortical pathology in MS from the onset of the disease, allowing to a better understanding of its origins and its impact and disease severity. This study is a preliminary requirement to longitudinal studies to precisely depict the kinetic of cortical lesion accumulation and the links with disease aggravation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis (MS)

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
patient with multiple sclerosis (MS)
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
MRI 7T
Intervention Description
MRI 7T
Intervention Type
Other
Intervention Name(s)
TEST EDSS
Intervention Description
EDSS - Expanded Disability Status Scale
Intervention Type
Other
Intervention Name(s)
TEST MSFC
Intervention Description
MSFC - Multiple Sclerosis Functional Composite
Primary Outcome Measure Information:
Title
visualization of cortical lesions
Description
By IRM 7T
Time Frame
12 MONTHS
Secondary Outcome Measure Information:
Title
measure of physical disability
Description
score EDSS
Time Frame
12 months
Title
cognitive impairment index
Description
score IAC
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with relapsing-remitting MS (McDonald's criteria 2010) early (duration evolution <2 years), Age between 18 and 45 years, No history of neurological symptoms suggestive of demyelinating pathology, No corticosteroids in the month preceding the completion of the MRI, Realization of the MRI in the first 6 months following the inaugural clinical episod Exclusion Criteria: Argument for a differential diagnosis (systemic lupus erythematosus, antiphospholipid syndrome, Behçet's disease, sarcoidosis, Lyme disease, cerebral arteritis, lymphoma CNS, etc.), History of neurological or psychiatric illness, History of taking immunosuppressive drugs, Claustrophobia Pregnancy, Patient unable or unwilling to give consent, patient under guardianship, Patient not affiliated to a social security regime
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
adil MAAROUF
Email
adil.maarouf@ap-hm.fr
First Name & Middle Initial & Last Name or Official Title & Degree
ALEXANDRA GIULIANI
Phone
+334 91 38 27 47
Email
drci@ap-hm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jean-olivier ARNAUD
Organizational Affiliation
Assistance Publique Hopitaux De Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
alexandra GIULIANI
Phone
04 91 38 27 47
Email
drci@ap-hm.fr
First Name & Middle Initial & Last Name & Degree
adil maarouf

12. IPD Sharing Statement

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Characterization of Cortical Injury in Early MS Patients: a 7T MRI Study

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