VASOSEP: Study by Magnetic Resonance Imaging in the Progressive Forms of Multiple Sclerosis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Progressive Multiple Sclerosis 22 patients with Progressive Multiple Sclerosis will be included and they get an Neuropsychological assessment, a Neurologic consultation and MRIs (with vasoreactivity testing) |
Other: Neuropsychological assessment
A neuropsychological assessment is done
Other: Neurologic consultation
A neurologic consultation is done
Other: MRIs (with vasoreactivity testing)
MRIs (with vasoreactivity testing) is done
|
| Experimental: Multiple Sclerosis, Relapsing-Remitting 22 patients with Multiple Sclerosis, Relapsing-Remitting will be included and they get an Neuropsychological assessment, a Neurologic consultation and MRIs (with vasoreactivity testing) |
Other: Neuropsychological assessment
A neuropsychological assessment is done
Other: Neurologic consultation
A neurologic consultation is done
Other: MRIs (with vasoreactivity testing)
MRIs (with vasoreactivity testing) is done
|
| Experimental: Healthy volunteers (22 patients) 22 healthy volunteers will be included and they get an Neuropsychological assessment and MRIs (with vasoreactivity testing) |
Other: Neuropsychological assessment
A neuropsychological assessment is done
Other: MRIs (with vasoreactivity testing)
MRIs (with vasoreactivity testing) is done
|
Outcome Measures
Primary Outcome Measures
- Cerebral vasoreactivity measured by diffusion imaging MRI (quantitative variable) :parameter which allow us to estimate the organization of the white matter tracts [2 months]
Secondary Outcome Measures
- Comparison of fonctional connective cards at Resting state [2 months]
somatomotor network and default mode network
- Cognitive disorders [2 months]
Neuropsychological test results (quantitative and quantitative variable)
Eligibility Criteria
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.
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Collection of the informed consent
-
Affiliation or recipient with the mode of social security.
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For the patients :
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Suffering from progressive multiple sclerosis (primary progressive forms or secondary progressive forms) OR
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Suffering from relapsing-remitting multiple sclerosis
Exclusion Criteria :
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For Both patients and healthy volunteers :
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Systemic pathology with neurological manifestations
-
Antecedent of psychiatric disorders including psychosis (Except anxious depressive disorder)
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Subject presenting contraindications in MRI (Ferromagnetic foreign bodies, pace-maker)
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Claustrophobia
-
Women pregnant or Breast-feeding
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Person with majority age protected by the law (supervision, trusteeship or under safeguard of justice).
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Subject unable to understand the nature and the aim of the study and/or communication difficulties with investigator
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Antecedent of serious cranial trauma (according to classification) of ischaemic stroke ou intracranial hematoma.
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For the patients :
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Antecedent of serious cranial trauma (according to classification), anterior or evolutive neurologic disease other than multiple sclerosis
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Recent relapse of multiple sclerosis
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hopital Gui de Chauliac -Service de Neurologie | Montpellier | France | 34295 |
Sponsors and Collaborators
- University Hospital, Montpellier
- Genzyme, a Sanofi Company
Investigators
- Principal Investigator: Pierre LABAUGE, Professor, University Hospital, Montpellier
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 9090