search
Back to results

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

Primary Purpose

Progressive Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Neuropsychological assessment
Neurologic consultation
MRIs (with vasoreactivity testing)
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Progressive Multiple Sclerosis

Eligibility Criteria

30 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Hopital Gui de Chauliac -Service de Neurologie

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Progressive Multiple Sclerosis

Multiple Sclerosis, Relapsing-Remitting

Healthy volunteers (22 patients)

Arm Description

22 patients with Progressive Multiple Sclerosis will be included and they get an Neuropsychological assessment, a Neurologic consultation and MRIs (with vasoreactivity testing)

22 patients with Multiple Sclerosis, Relapsing-Remitting will be included and they get an Neuropsychological assessment, a Neurologic consultation and MRIs (with vasoreactivity testing)

22 healthy volunteers will be included and they get an Neuropsychological assessment and MRIs (with vasoreactivity testing)

Outcomes

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

Secondary Outcome Measures

Comparison of fonctional connective cards at Resting state
somatomotor network and default mode network
Cognitive disorders
Neuropsychological test results (quantitative and quantitative variable)

Full Information

First Posted
September 25, 2015
Last Updated
May 14, 2021
Sponsor
University Hospital, Montpellier
Collaborators
Genzyme, a Sanofi Company
search

1. Study Identification

Unique Protocol Identification Number
NCT02580669
Brief Title
Study by Magnetic Resonance Imaging in the Progressive Forms of Multiple Sclerosis
Acronym
VASOSEP
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

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Terminated
Why Stopped
Inclusion period ended
Study Start Date
June 16, 2014 (Actual)
Primary Completion Date
February 13, 2017 (Actual)
Study Completion Date
February 13, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
Collaborators
Genzyme, a Sanofi Company

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Progressive Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Progressive Multiple Sclerosis
Arm Type
Experimental
Arm Description
22 patients with Progressive Multiple Sclerosis will be included and they get an Neuropsychological assessment, a Neurologic consultation and MRIs (with vasoreactivity testing)
Arm Title
Multiple Sclerosis, Relapsing-Remitting
Arm Type
Experimental
Arm Description
22 patients with Multiple Sclerosis, Relapsing-Remitting will be included and they get an Neuropsychological assessment, a Neurologic consultation and MRIs (with vasoreactivity testing)
Arm Title
Healthy volunteers (22 patients)
Arm Type
Experimental
Arm Description
22 healthy volunteers will be included and they get an Neuropsychological assessment and MRIs (with vasoreactivity testing)
Intervention Type
Other
Intervention Name(s)
Neuropsychological assessment
Intervention Description
A neuropsychological assessment is done
Intervention Type
Other
Intervention Name(s)
Neurologic consultation
Intervention Description
A neurologic consultation is done
Intervention Type
Other
Intervention Name(s)
MRIs (with vasoreactivity testing)
Intervention Description
MRIs (with vasoreactivity testing) is done
Primary Outcome Measure Information:
Title
Cerebral vasoreactivity measured by diffusion imaging MRI (quantitative variable) :parameter which allow us to estimate the organization of the white matter tracts
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Comparison of fonctional connective cards at Resting state
Description
somatomotor network and default mode network
Time Frame
2 months
Title
Cognitive disorders
Description
Neuropsychological test results (quantitative and quantitative variable)
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre LABAUGE, Professor
Organizational Affiliation
University Hospital, Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Gui de Chauliac -Service de Neurologie
City
Montpellier
ZIP/Postal Code
34295
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs