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

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

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.

Study Overview

• Status: Terminated
• Conditions: Progressive Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting
• Intervention / Treatment: Other: Neuropsychological assessment; Other: Neurologic consultation; Other: MRIs (with vasoreactivity testing)

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Hopital Gui de Chauliac -Service de Neurologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
Comparison of fonctional connective cards at Resting state	somatomotor network and default mode network	2 months
Cognitive disorders	Neuropsychological test results (quantitative and quantitative variable)	2 months

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: Genzyme, a Sanofi Company
• Investigators: Principal Investigator: Pierre LABAUGE, Professor, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2014
• Primary Completion (Actual): February 13, 2017
• Study Completion (Actual): February 13, 2017

Study Registration Dates

• First Submitted: September 25, 2015
• First Submitted That Met QC Criteria: October 16, 2015
• First Posted (Estimate): October 20, 2015

Study Record Updates

• Last Update Posted (Actual): May 18, 2021
• Last Update Submitted That Met QC Criteria: May 14, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis; Multiple Sclerosis, Relapsing-Remitting
• Other Study ID Numbers: 9090