Multiple Sclerosis, Relapsing-Remitting Clinical Trial
— VASOSEPOfficial title:
Study by Magnetic Resonance Imaging of the Modifications of the Vasoreactivity and Cerebral Connectivity in the Progressive Forms of Multiple Sclerosis
NCT number | NCT02580669 |
Other study ID # | 9090 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | June 16, 2014 |
Est. completion date | February 13, 2017 |
Verified date | May 2021 |
Source | University Hospital, Montpellier |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 70 |
Est. completion date | February 13, 2017 |
Est. primary completion date | February 13, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 30 Years to 50 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
France | Hopital Gui de Chauliac -Service de Neurologie | Montpellier |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Montpellier | Genzyme, a Sanofi Company |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Comparison of fonctional connective cards at Resting state | somatomotor network and default mode network | 2 months | |
Secondary | Cognitive disorders | Neuropsychological test results (quantitative and quantitative variable) | 2 months |
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