MSGM7T: Grey Matter Damage at the Earliest Phase of Multiple Sclerosis : a Longitudinal 7T MRI Study

Sponsor

Assistance Publique Hopitaux De Marseille (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03659981

Collaborator

(none)

Enrollment

Location

Arm

73.6

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis	Other: MRI 7T	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Grey Matter Damage at the Earliest Phase of Multiple Sclerosis : a Longitudinal 7T Magnetic Resonance Imaging Study

Actual Study Start Date :

Nov 13, 2018

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MS Patients Multiple sclerosis patients MRI 7T will be performed	Other: MRI 7T The imaging parameters will come from the 7 Tesla Siemens MRI

Arm

Intervention/Treatment

Experimental: MS Patients

Multiple sclerosis patients MRI 7T will be performed

Other: MRI 7T

The imaging parameters will come from the 7 Tesla Siemens MRI

Outcome Measures

Primary Outcome Measures

number of cortical lesions [2 hours]
Cortical lesion detection on 7T MRI at baseline

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assistance Publique Des Hopitaux de Marseille	Marseille	Paca	France	13354

Sponsors and Collaborators

Assistance Publique Hopitaux De Marseille

Investigators

Study Director: EMILIE GARRIDO PRADALIE, APHM

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Assistance Publique Hopitaux De Marseille

ClinicalTrials.gov Identifier:

NCT03659981

Other Study ID Numbers:

2018-01

First Posted:

Sep 6, 2018

Last Update Posted:

Aug 2, 2022

Last Verified:

Aug 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Multiple Sclerosis

Sclerosis

Study Results

No Results Posted as of Aug 2, 2022