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Clinical Trials in France / NCT03659981
Active, not recruiting Not applicable

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

NCT03659981 · tracked via the Priya Life Science France tracker
Sponsor
Assistance Publique Hopitaux De Marseille
Phase
Not applicable
Started
2018-12-20
Last updated
2024-08-06

Condition(s) studied

Multiple Sclerosis

Investigational drug(s) / intervention(s)

MRI 7T

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

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
50 Years
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: * 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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Assistance Publique Des Hopitaux de Marseille Marseille PACA

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03659981 on ClinicalTrials.gov ↗ ← All trials in France