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Active, Not Recruiting

NCT Number: NCT03356366

MRI Study of the Mechanisms Underlying Irreversible Disability in Multiple Sclerosis

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assistance Publique - Hôpitaux de Marseille

Marseille, 13005, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

MRI 3T

Other

Magnetic Resonance Imaging 3 Tesla

MRI 1,5T

Other

Magnetic Resonance Imaging 1,5 Tesla

MRI 7T

Other

Magnetic Resonance Imaging 7 Tesla

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

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Official study title

Magnetic Resonance Imaging Study of the Mechanisms Underlying Irreversible Disability in Multiple Sclerosis

Acronym: SEP-MRI

Important dates

Study start
2017
Primary completion
2023
Study completion
2028
First posted
Nov 29, 2017
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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