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

NCT ID: NCT02580669

Last Updated: 2021-05-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-16
• Study Completion Date: 2017-02-13

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.

Conditions

Progressive Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Neuropsychological assessment

Intervention Type: OTHER

A neuropsychological assessment is done

Neurologic consultation

Intervention Type: OTHER

A neurologic consultation is done

MRIs (with vasoreactivity testing)

Intervention Type: OTHER

MRIs (with vasoreactivity testing) is done

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)

Group Type: EXPERIMENTAL

Neuropsychological assessment

Intervention Type: OTHER

A neuropsychological assessment is done

Neurologic consultation

Intervention Type: OTHER

A neurologic consultation is done

MRIs (with vasoreactivity testing)

Intervention Type: OTHER

MRIs (with vasoreactivity testing) is done

Healthy volunteers (22 patients)

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

Group Type: EXPERIMENTAL

Neuropsychological assessment

Intervention Type: OTHER

A neuropsychological assessment is done

MRIs (with vasoreactivity testing)

Intervention Type: OTHER

MRIs (with vasoreactivity testing) is done

Interventions

Neuropsychological assessment

A neuropsychological assessment is done

Intervention Type: OTHER

Neurologic consultation

A neurologic consultation is done

Intervention Type: OTHER

MRIs (with vasoreactivity testing)

MRIs (with vasoreactivity testing) is done

Intervention Type: OTHER

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role: collaborator

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre LABAUGE, Professor

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

Hopital Gui de Chauliac -Service de Neurologie

Montpellier, , France

Countries

France

Other Identifiers

9090

Identifier Type: -

Identifier Source: org_study_id