Study by Magnetic Resonance Imaging in the Progressive Forms of Multiple Sclerosis (VASOSEP)

University Hospital Center (CHU)

Status: Terminated

Conditions: Multiple Sclerosis, Relapsing-Remitting; Progressive Multiple Sclerosis

Treatments: Other: MRIs (with vasoreactivity testing); Other: Neuropsychological assessment; Other: Neurologic consultation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02580669

9090

Details and patient eligibility

About

The goal of this study is to show pattern differences of vasoreactivity and connectivity between Progressive Multiple Sclerosis and Relapsing Remitting Multiple Sclerosis, by the use of methods of advanced brain MRIs and the Diffusion Tensor Imaging , and correlate these differences with Clinical disability and cognitive disorder results.

Full description

The goal of this study is to show pattern differences of vasoreactivity and connectivity between Progressive Multiple Sclerosis and Relapsing Remitting Multiple Sclerosis, by the use of methods of advanced brain MRIs, and correlate these differences with Clinical disability and cognitive disorder results. The modification of the Diffusion Tensor Imaging are well known in these two groups, as well as their link with the occurrence of movement and cognitive disorder. The study of the vasoreactivity during MRI aims to confront our results to the available data sources.

Enrollment: 70 patients

Sex: All

Ages: 30 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria :

• For Both patients and healthy volunteers :
• Age limits ≥ 30 et ≤ 50 years
• Subject able to understand the nature, the aim and the methodology of the study.
• Collection of the informed consent
• Affiliation or recipient with the mode of social security.
• For the patients :
• Suffering from progressive multiple sclerosis (primary progressive forms or secondary progressive forms) OR
• Suffering from relapsing-remitting multiple sclerosis

Exclusion Criteria :

• For Both patients and healthy volunteers :
• Systemic pathology with neurological manifestations
• Antecedent of psychiatric disorders including psychosis (Except anxious depressive disorder)
• Subject presenting contraindications in MRI (Ferromagnetic foreign bodies, pace-maker)
• Claustrophobia
• Women pregnant or Breast-feeding
• Person with majority age protected by the law (supervision, trusteeship or under safeguard of justice).
• Subject unable to understand the nature and the aim of the study and/or communication difficulties with investigator
• Antecedent of serious cranial trauma (according to classification) of ischaemic stroke ou intracranial hematoma.
• For the patients :
• Antecedent of serious cranial trauma (according to classification), anterior or evolutive neurologic disease other than multiple sclerosis
• Recent relapse of multiple sclerosis
• For the healthy volunteers :
• Antecedent of serious cranial trauma (according to classification), anterior or evolutive neurologic disease
• Antecedent of neurological disease
• In period of exclusion relative to another protocol or which the annual amount of the allowances maximum of 4500 € was reached.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 3 patient groups

Progressive Multiple Sclerosis

Experimental group

Description:

22 patients with Progressive Multiple Sclerosis will be included and they get an Neuropsychological assessment, a Neurologic consultation and MRIs (with vasoreactivity testing)

Treatment:

Other: MRIs (with vasoreactivity testing)

Other: Neurologic consultation

Other: Neuropsychological assessment

Multiple Sclerosis, Relapsing-Remitting

Experimental group

Description:

22 patients with Multiple Sclerosis, Relapsing-Remitting will be included and they get an Neuropsychological assessment, a Neurologic consultation and MRIs (with vasoreactivity testing)

Treatment:

Other: MRIs (with vasoreactivity testing)

Other: Neurologic consultation

Other: Neuropsychological assessment

Healthy volunteers (22 patients)

Experimental group

Description:

22 healthy volunteers will be included and they get an Neuropsychological assessment and MRIs (with vasoreactivity testing)

Treatment:

Other: MRIs (with vasoreactivity testing)

Other: Neuropsychological assessment