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

NCT02580669 | Terminated

• 1 other identifier: 9090
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Progressive Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Comparison of fonctional connective cards at Resting state

  2 months

• Cognitive disorders

  2 months

Study Arms (3)

Progressive Multiple Sclerosis

EXPERIMENTAL

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; Other: Neurologic consultation; Other: MRIs (with vasoreactivity testing)

Multiple Sclerosis, Relapsing-Remitting

EXPERIMENTAL

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; Other: Neurologic consultation; Other: MRIs (with vasoreactivity testing)

Healthy volunteers (22 patients)

EXPERIMENTAL

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

Other: Neuropsychological assessment; Other: MRIs (with vasoreactivity testing)

Interventions

Neuropsychological assessment OTHER

A neuropsychological assessment is done

Healthy volunteers (22 patients); Multiple Sclerosis, Relapsing-Remitting; Progressive Multiple Sclerosis

Neurologic consultation OTHER

A neurologic consultation is done

Multiple Sclerosis, Relapsing-Remitting; Progressive Multiple Sclerosis

MRIs (with vasoreactivity testing) OTHER

MRIs (with vasoreactivity testing) is done

Healthy volunteers (22 patients); Multiple Sclerosis, Relapsing-Remitting; Progressive Multiple Sclerosis

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Genzyme, a Sanofi Company: collaborator

Study Sites (1)

Hopital Gui de Chauliac -Service de Neurologie

Montpellier, 34295, France

Location

MeSH Terms

Conditions

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

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Pierre LABAUGE, Professor

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2015
• First Posted: October 20, 2015
• Study Start: June 16, 2014
• Primary Completion: February 13, 2017
• Study Completion: February 13, 2017
• Last Updated: May 18, 2021

Record last verified: 2021-05

Locations

FR (1)