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Active, not recruitingNCT03356366SEP-MRIUpdated Aug 6, 2024

MRI Study of the Mechanisms Underlying Irreversible Disability in Multiple Sclerosis

An interventional study of MRI 3T and MRI 1,5T in Multiple Sclerosis, sponsored by Assistance Publique Hopitaux De Marseille. Active, not recruiting at 1 site in France. Open to participants aged 18 Years and older. 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
70
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

Multiple sclerosis (MS) is the first non-traumatic cause of disability in young people, responsible for physical but also cognitive deficits. MS is an inflammatory demyelinating and degenerative disease of the central nervous system. Recently, MRI technics have demonstrated their sensibility to the different processes involved in MS. Particularly, MRI has evidenced that the pathological process of MS is not restricted to the macroscopic lesions of the white matter but also involves the normal appearing white and grey matter. In the normal appearing brain tissue, demyelination, neuronal suffering and neuronal loss have been evidenced. Moreover, MRI has demonstrated the existence of brain functional reorganization processes that may limit the clinical expression of pathological injuries. Despite these important findings, the pathological underpinnings of irreversible disability are largely unknown. The present project aims to depict the main determinants of physical but also cognitive disability in patients with MS. To do this, a longitudinal study including 70 patients with MS using different MRI markers known to be sensitive to the different pathological aspects of MS will be performed. The relationships between these markers and the progression of disability will be assessed. Identification of the main pathological underpinnings of irreversible disability of MS will provide the most relevant therapeutic targets.

02

Conditions studied

  • Multiple Sclerosis
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Major patient,
  • Patient affiliated to a health insurance plan
  • Patient having signed free and informed consent after receiving detailed, understandable and honest information,
  • Patient with multiple sclerosis according to the criteria of Polman 2010

Exclusion criteria

Exclusion Criteria:

  • Patients with the usual contraindications to MRI (pace-maker, agitation, metal splinters, claustrophobia etc.)
  • Patients at risk of non-compliance on examination: impaired understanding, confusion, involuntary movements, poor tolerance of prolonged supine
  • Patients with known allergy to gadolinium
  • Patients with renal insufficiency
  • Patients unable to give their consent: disorders of the comprehension, disturbances of vigilance, confusion ...
  • Pregnant and breastfeeding woman
  • Patients with a history of neurological or psychiatric pathology
  • Patients under guardianship or curatorship
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (actual)

Study arms

  • Experimental
    Principal study

    Patients pathological process will be assessed using MRI 3T

    Other: MRI 3T

  • Experimental
    Ancillary study 1

    Patients pathological process will be assessed using MRI 1,5T

    Other: MRI 1,5T

  • Experimental
    Ancillary study 2

    Patients pathological process will be assessed using MRI 7T

    Other: MRI 7T

Interventions

  • OtherMRI 3T

    Magnetic Resonance Imaging 3 Tesla

  • OtherMRI 1,5T

    Magnetic Resonance Imaging 1,5 Tesla

  • OtherMRI 7T

    Magnetic Resonance Imaging 7 Tesla

05

What researchers measure

Primary outcomes

  1. Measurement of the Expanded Disability Status Scale (EDSS) value (score from 0 to 20) constituing the actual international reference scale to measure the level of disability caused by parkinson disease

    Time frame: 5 years

06

Study locations

1 site
  • Assistance Publique - Hôpitaux de Marseille
    Marseille, 13005, France
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03356366
Lead sponsor
Assistance Publique Hopitaux De Marseille
Responsible party
Sponsor
First posted
Nov 29, 2017
Start date
Oct 2, 2017
Primary completion
Jan 16, 2023
Completion
Dec 31, 2028 (estimated)
Last update
Aug 6, 2024

Study contacts

Jean-Olivier ARNAUD
study director · Assistance Publique - Hôpitaux de Marseille

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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