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MRI Study of the Mechanisms Underlying Irreversible Disability in Multiple Sclerosis (SEP-MRI)

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ClinicalTrials.gov Identifier: NCT03356366
Recruitment Status : Recruiting
First Posted : November 29, 2017
Last Update Posted : November 29, 2017
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Brief 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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Other: MRI 3T Other: MRI 1,5T Other: MRI 7T Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Magnetic Resonance Imaging Study of the Mechanisms Underlying Irreversible Disability in Multiple Sclerosis
Actual Study Start Date : October 2, 2017
Estimated Primary Completion Date : October 2, 2027
Estimated Study Completion Date : December 31, 2027

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Arm Intervention/treatment
Experimental: Principal study
Patients pathological process will be assessed using MRI 3T
Other: MRI 3T
Magnetic Resonance Imaging 3 Tesla

Experimental: Ancillary study 1
Patients pathological process will be assessed using MRI 1,5T
Other: MRI 1,5T
Magnetic Resonance Imaging 1,5 Tesla

Experimental: Ancillary study 2
Patients pathological process will be assessed using MRI 7T
Other: MRI 7T
Magnetic Resonance Imaging 7 Tesla




Primary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03356366


Contacts
Contact: Bertrand AUDOIN, MD-PhD bertrand.audoin@ap-hm.fr
Contact: Camille DELANNOY camille.delannoy@ap-hm.fr

Locations
France
Assistance Publique - Hôpitaux de Marseille Recruiting
Marseille, France, 13005
Contact: AUDOIN Bertrand       bertrand.audoin@ap-hm.fr   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Study Director: Jean-Olivier ARNAUD Assistance Publique - Hôpitaux de Marseille

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT03356366     History of Changes
Other Study ID Numbers: 2016-52
2017-A00136-47 ( Other Identifier: ANSM )
First Posted: November 29, 2017    Key Record Dates
Last Update Posted: November 29, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases