Clinical trial NCT02580669: Study by Magnetic Resonance Imaging in the Progressive Forms of Multiple Sclerosis
Official title: Study by Magnetic Resonance Imaging of the Modifications of the Vasoreactivity and Cerebral Connectivity in the Progressive Forms of Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Progressive Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Genzyme, a Sanofi Company
First posted: 2015-10-20
Enrollment: 70
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Cerebral vasoreactivity measured by diffusion imaging MRI (quantitative variable) :parameter which allow us to estimate the organization of the white matter tracts
timeFrame: 2 months
Secondary outcomes:
measure: Comparison of fonctional connective cards at Resting state
timeFrame: 2 months
measure: Cognitive disorders
timeFrame: 2 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Hopital Gui de Chauliac -Service de Neurologie
Study officials:
affiliation: University Hospital, Montpellier
name: Pierre LABAUGE, Professor
role: PRINCIPAL_INVESTIGATOR
References: