MRI Study of the Mechanisms Underlying Irreversible Disability in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— SEP-MRI  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03356366
• Other study ID #: 2016-52
• Secondary ID: 2017-A00136-47
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2, 2017
• Est. completion date: December 31, 2028

Study information

• Verified date: July 2023
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: December 31, 2028
• Est. primary completion date: January 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• MRI 3T
Magnetic Resonance Imaging 3 Tesla
• MRI 1,5T
Magnetic Resonance Imaging 1,5 Tesla
• MRI 7T
Magnetic Resonance Imaging 7 Tesla

Locations

Country	Name	City	State
France	Assistance Publique - Hôpitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		5 years