CClinicalTrials.gg
Active, not recruitingNCT03659981MSGM7TUpdated Aug 6, 2024

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

An interventional study of MRI 7T in Multiple Sclerosis, sponsored by Assistance Publique Hopitaux De Marseille. Active, not recruiting at 1 site in France. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-08-06.

Sponsored by Assistance Publique Hopitaux De Marseille · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Not applicable
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Multiple Sclerosis
03

In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 32 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Assistance Publique Hopitaux De Marseille is the lead sponsor of 686 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    MS Patients

    Multiple sclerosis patients MRI 7T will be performed

    Other: MRI 7T

Interventions

  • OtherMRI 7T

    The imaging parameters will come from the 7 Tesla Siemens MRI

06

What researchers measure

Primary outcomes

  1. number of cortical lesions

    Cortical lesion detection on 7T MRI at baseline

    Time frame: 2 hours

07

Study locations

1 site
  • Assistance Publique Des Hopitaux de Marseille
    Marseille, Paca 13354, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03659981
Lead sponsor
Assistance Publique Hopitaux De Marseille
Responsible party
Sponsor
First posted
Sep 6, 2018
Start date
Dec 20, 2018
Primary completion
May 19, 2022
Completion
Nov 19, 2026 (estimated)
Last update
Aug 6, 2024

Study contacts

EMILIE GARRIDO PRADALIE
study director · APHM

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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