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

Multiple Sclerosis Clinical Trial

— MSGM7T  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03659981
• Other study ID #: 2018-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 20, 2018
• Est. completion date: May 18, 2024

Study information

• Verified date: July 2023
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. completion date: May 18, 2024
• Est. primary completion date: May 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• MRI 7T
The imaging parameters will come from the 7 Tesla Siemens MRI

Locations

Country	Name	City	State
France	Assistance Publique Des Hopitaux de Marseille	Marseille	Paca

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of cortical lesions	Cortical lesion detection on 7T MRI at baseline	2 hours