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

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

— VASOSEP  

Official title:

Study by Magnetic Resonance Imaging of the Modifications of the Vasoreactivity and Cerebral Connectivity in the Progressive Forms of Multiple Sclerosis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02580669
• Other study ID #: 9090
• Status: Terminated
• Phase: N/A
• Start date: June 16, 2014
• Est. completion date: February 13, 2017

Study information

• Verified date: May 2021
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Chronic Progressive
• Multiple Sclerosis, Relapsing-Remitting
• Progressive Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Neuropsychological assessment
A neuropsychological assessment is done
• Neurologic consultation
A neurologic consultation is done
• MRIs (with vasoreactivity testing)
MRIs (with vasoreactivity testing) is done

Locations

Country	Name	City	State
France	Hopital Gui de Chauliac -Service de Neurologie	Montpellier

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Montpellier	Genzyme, a Sanofi Company

Country where clinical trial is conducted

France, 

Outcome

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