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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02580669
Acronym
VASOSEP
Enrollment
70
Registered
2015-10-20
Start date
2014-06-16
Completion date
2017-02-13
Last updated
2021-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting, Progressive Multiple Sclerosis

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.

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

Sponsors

Genzyme, a Sanofi Company
CollaboratorINDUSTRY
University Hospital, Montpellier
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 50 Years
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

: * 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.

Design outcomes

Primary

MeasureTime frame
Cerebral vasoreactivity measured by diffusion imaging MRI (quantitative variable) :parameter which allow us to estimate the organization of the white matter tracts2 months

Secondary

MeasureTime frameDescription
Comparison of fonctional connective cards at Resting state2 monthssomatomotor network and default mode network
Cognitive disorders2 monthsNeuropsychological test results (quantitative and quantitative variable)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026