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MRI Study of the Mechanisms Underlying Irreversible Disability in Multiple Sclerosis

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03356366
Acronym
SEP-MRI
Enrollment
70
Registered
2017-11-29
Start date
2017-10-02
Completion date
2028-12-31
Last updated
2024-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

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.

Interventions

OTHERMRI 3T

Magnetic Resonance Imaging 3 Tesla

OTHERMRI 1,5T

Magnetic Resonance Imaging 1,5 Tesla

OTHERMRI 7T

Magnetic Resonance Imaging 7 Tesla

Sponsors

Assistance Publique Hopitaux De Marseille
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

* 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

Design outcomes

Primary

MeasureTime frame
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 disease5 years

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026