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

NCT03659981 | Active Not Recruiting

• 1 other identifier: 2018-01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• number of cortical lesions

  Cortical lesion detection on 7T MRI at baseline

  2 hours

Study Arms (1)

MS Patients

EXPERIMENTAL

Multiple sclerosis patients MRI 7T will be performed

Other: MRI 7T

Interventions

MRI 7T OTHER

The imaging parameters will come from the 7 Tesla Siemens MRI

MS Patients

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Des Hopitaux de Marseille

Marseille, PACA, 13354, France

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• EMILIE GARRIDO PRADALIE

  APHM

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2018
• First Posted: September 6, 2018
• Study Start: December 20, 2018
• Primary Completion: May 19, 2022
• Study Completion (Estimated): November 19, 2026
• Last Updated: August 6, 2024

Record last verified: 2024-08

Locations

FR (1)