Progressive Multiple SclerosisVASOSEPNCT02580669
Study by Magnetic Resonance Imaging in the Progressive Forms of Multiple Sclerosis
A study testing Neuropsychological assessment, Neurologic consultation and MRIs (with vasoreactivity testing) in people with Progressive Multiple Sclerosis and Multiple Sclerosis, Relapsing-Remitting, run by University Hospital, Montpellier at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Progressive Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- Neuropsychological assessment, Neurologic consultation and MRIs (with vasoreactivity testing)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jun 2014to 13 Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study by Magnetic Resonance Imaging of the Modifications of the Vasoreactivity and Cerebral Connectivity in the Progressive Forms of Multiple Sclerosis
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.
- Being tested
- Neuropsychological assessment, Neurologic consultation, MRIs (with vasoreactivity testing)
- Medical subject headings
- Multiple Sclerosis, Chronic Progressive, Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological assessmentOther
A neuropsychological assessment is done
Neurologic consultationOther
A neurologic consultation is done
MRIs (with vasoreactivity testing)Other
MRIs (with vasoreactivity testing) is done
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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) Receives: Other: Neuropsychological assessment; Other: MRIs (with vasoreactivity testing) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral vasoreactivity measured by diffusion imaging MRI (quantitative variable) :parameter which allow us to estimate the organization of the white matter tracts
Measured: 2 months
Secondary outcomes (2)
Comparison of fonctional connective cards at Resting state
somatomotor network and default mode network
Measured: 2 months
Cognitive disorders
Neuropsychological test results (quantitative and quantitative variable)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2015 (estimated)
- Study start16 Jun 2014
- Primary completion13 Feb 2017
- Study completion13 Feb 2017
Why it stopped: Inclusion period ended
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progressive Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Responsible party
- Sponsor
- Investigators
- Pierre LABAUGE, Professor, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02580669
- Sponsor's protocol ID
- 9090
- Acronym
- VASOSEP
- Status last verified
- May 2021
- First submitted
- 25 Sep 2015
- Last updated
- 18 May 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study by Magnetic Resonance Imaging of the Modifications of the Vasoreactivity and Cerebral Connectivity in the Progressive Forms of Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02580669
- Acronym / sponsor ID
- VASOSEP / 9090
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inclusion period ended
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Study start
- 16 Jun 2014 (actual)
- Primary completion
- 13 Feb 2017 (actual)
- Study completion
- 13 Feb 2017 (actual)
- First posted
- 20 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Progressive Multiple Sclerosis | Experimental | Other: Neuropsychological assessment, Other: Neurologic consultation, Other: MRIs (with vasoreactivity testing)22 patients with Progressive Multiple Sclerosis will be included and they get an Neuropsychological assessment, a Neurologic consultation and MRIs (with vasoreactivity testing) |
| Multiple Sclerosis, Relapsing-Remitting | Experimental | Other: Neuropsychological assessment, Other: Neurologic consultation, Other: 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) |
| Healthy volunteers (22 patients) | Experimental | Other: Neuropsychological assessment, Other: MRIs (with vasoreactivity testing)22 healthy volunteers will be included and they get an Neuropsychological assessment and MRIs (with vasoreactivity testing) |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuropsychological assessmentA neuropsychological assessment is done | Other | Healthy volunteers (22 patients), Multiple Sclerosis, Relapsing-Remitting, Progressive Multiple Sclerosis |
| Neurologic consultationA neurologic consultation is done | Other | Multiple Sclerosis, Relapsing-Remitting, Progressive Multiple Sclerosis |
| MRIs (with vasoreactivity testing)MRIs (with vasoreactivity testing) is done | Other | Healthy volunteers (22 patients), Multiple Sclerosis, Relapsing-Remitting, Progressive Multiple Sclerosis |
Primary outcome
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
2 secondary outcomes
Comparison of fonctional connective cards at Resting state
Time frame: 2 months
Cognitive disorders
Time frame: 2 months
Results and safety
The study was stopped early (reason given: Inclusion period ended). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre LABAUGE, Professor principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuropsychological assessment, Neurologic consultation and MRIs (with vasoreactivity testing) in people with Progressive Multiple Sclerosis and Multiple Sclerosis, Relapsing-Remitting, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Inclusion period ended). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2021.