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NCT03659981Active, not recruiting

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

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

Source: ClinicalTrials.gov · Last updated 6 Aug 2024

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
32 (actual)
First submitted
4 Sept 2018
Start date
20 Dec 2018
Primary completion date
19 May 2022
Lead sponsor
Assistance Publique Hopitaux De Marseille
NCT number
NCT03659981

What you commit to

  • Study type: Interventional
  • Participants enrolled: 32
  • From 20 Dec 2018 to the primary completion date, 19 May 2022
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous history of neurological or psychiatric disease
  • Previous administration of immunosuppressive drugs

Other

  • Possible alternative diagnoses
  • Pregnancy
  • Patient unable to give his consent for the study or patient under tutorship

Who the study is looking for

  • 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

Age in the registry: 18 years to 50 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Assistance Publique Des Hopitaux de Marseille
Coordinator of this site? Confirm its status
MarseilleFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.