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TerminatedNCT02580669VASOSEPUpdated May 18, 2021

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

An interventional study of Neuropsychological assessment and Neurologic consultation in Progressive Multiple Sclerosis and Multiple Sclerosis, Relapsing-Remitting, sponsored by University Hospital, Montpellier. Terminated at 1 site in France. Open to participants aged 30 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-18.

Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Diagnostic

Why this study was terminated
Inclusion period ended

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Jun 2014, registered Sep 2015).
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Non-randomized
Ages
30 Years to 50 Years
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Progressive Multiple Sclerosis
  • Multiple Sclerosis, Relapsing-Remitting
03

In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 70 is above the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
30 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (actual)

Study arms

  • 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 · Other: Neurologic consultation · Other: MRIs (with vasoreactivity testing)

  • 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 · Other: Neurologic consultation · Other: MRIs (with vasoreactivity testing)

  • 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 · Other: MRIs (with vasoreactivity testing)

Interventions

  • OtherNeuropsychological assessment

    A neuropsychological assessment is done

  • OtherNeurologic consultation

    A neurologic consultation is done

  • OtherMRIs (with vasoreactivity testing)

    MRIs (with vasoreactivity testing) is done

06

What researchers measure

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

    Time frame: 2 months

Secondary outcomes

  1. Comparison of fonctional connective cards at Resting state

    somatomotor network and default mode network

    Time frame: 2 months

  2. Cognitive disorders

    Neuropsychological test results (quantitative and quantitative variable)

    Time frame: 2 months

07

Study locations

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

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 18, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02580669
Lead sponsor
University Hospital, Montpellier
Collaborators
Genzyme, a Sanofi Company
Responsible party
Sponsor
First posted
Oct 20, 2015
Start date
Jun 16, 2014
Primary completion
Feb 13, 2017
Completion
Feb 13, 2017
Last update
May 18, 2021

Study contacts

Pierre LABAUGE, Professor
principal investigator · University Hospital, Montpellier

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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