Multiple SclerosisSOCOG-MSNCT02290587
Study of Social Cognition by Morphological and Functional Imaging in Multiple Sclerosis Patients
A study testing Brain MRI - Clinical and cognitive evaluation and MRI in people with Multiple Sclerosis, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
In recent years, studies have brought knowledge of the difficulties of social cognition in Multiple Sclerosis (MS). The brain tissue alteration at the origin of these difficulties in social cognition mechanisms remain poorly understood. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Brain MRI - Clinical and cognitive evaluation and MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2015to Mar 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 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18-59 years
- Right handed
- Fluent French speaker
- MS diagnosis according to McDonald criteria (Polman et al., 2005).
- Relapsing-remitting MS (RRMS) according to Lublin et al. (1996);
- Having signed an informed consent (later than the day of inclusion and before any examination required by research)
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- Being affiliated to health insurance
- Aged 18-59 years
- Right handed
- Fluent French speaker
- Having signed an informed consent (later than the day of inclusion and before any examination required by research)
- Being affiliated to health insurance
Who cannot join
- Other progressive neurological disease;
- psychiatric comorbidity including severe depression according to Diagnostic and Statistical Manual-IV (DSM-IV),
- alcohol or other addiction to toxic,
- Expanded Disability Status Scale (EDSS) > 6; disabling visual or motor problems preventing participation to neuropsychological assessments,
- relapse since less than one month,
- change of disease-modifying therapy or psychotropic drug since less than one month,
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- Contra-indication to MRI (pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body, claustrophobia) or refusing MRI
- Illiteracy, is unable to count or to read
- Pregnant or breastfeeding women
- Being under guardianship
- History of neurological disease;
- family history of MS;
- psychiatric comorbidity including severe depression according to DSM-IV;
- alcohol or other toxic addiction;
- psychotropic drugs; known cognitive complaint or neuropsychological affection;
- Prior neuropsychological testing with the same tests less than one year
- Contra-indication to MRI (pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body, claustrophobia) or refusing MRI
- Illiteracy, is unable to count or to read
- Pregnant or breastfeeding women
- Being under guardianship
Trial locations and contacts
1 site in 1 country.
About this study
In recent years, studies have brought knowledge of the difficulties of social cognition in Multiple Sclerosis (MS). The brain tissue alteration at the origin of these difficulties in social cognition mechanisms remain poorly understood. Although recent behavioral studies indicated social disturbances in many of these patients, functional studies investigating specific theory of mind in MS are lacking. The use of new techniques for morphological and functional Magnetic Resonance Imaging (MRI) can identify brain activation networks, mapping the achievement and tissue integrity may be related to disorders of social cognition and cognitive. The investigators propose to study social cognition in MS patients using morphological and functional imaging to determine the mechanisms underlying phenomena such as cerebral compensation and its relationship with cognitive impairment.
- Conditions
- Multiple Sclerosis
- Being tested
- Brain MRI - Clinical and cognitive evaluation, MRI
- Keywords
- social cognitive, theory of mind, cognitive impairment, functional MRI, brain activation network
- Medical subject headings
- Multiple Sclerosis, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain MRI - Clinical and cognitive evaluationOther
Neuropsychological evaluation :
- Questionnaire for depression and anxiety
- Evaluation of executive functions
- Evaluation of attention, information processing speed, verbal memory and working memory
Theory of mind evaluation
Clinical Evaluation
MRI Evaluation :
- morphological MRI
- functional MRI with two tasks of theory of mind : eyes test and test of attribution of intention
MRIDevice
| Study group | Role | What they receive |
|---|---|---|
| Patient | Experimental | MS diagnosis according to McDonald criteria (Polman et al., 2005). Relapsing-remitting MS (RRMS) according to Lublin et al. (1996); Receives: Other: Brain MRI - Clinical and cognitive evaluation; Device: MRI |
| Control | Experimental | healthy subject Receives: Other: Brain MRI - Clinical and cognitive evaluation; Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain activation networks during MRI
To identify brain activation networks during the two paradigms of theory of mind and executive function in RRMS patients taking into account cognitive impairment.
Measured: At inclusion (day 0)
Secondary outcomes (2)
Reduction of volume of deep brain structures and reduction of cortical thickness
Correlation between social cognitive z scores and atrophy measures (reduction of volume of deep brain structures and reduction of cortical thickness).
Measured: At inclusion (day 0)
White matter skeleton on Fractional Anisotropy (FA) maps established by voxel-based.
Comparison of white matter skeleton on Fractional Anisotropy (FA) maps established by voxel-based between RRMS patients and Healthy Control (HC) patients and in RRMS group taking into account cognitive impairment.
Measured: At inclusion (day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2014 (estimated)
- Study startNov 2015
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- La Ligue Française Contre la Sclérose en Plaques
- Responsible party
- Sponsor
- Investigators
- Bruno Brochet, Prof., Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02290587
- Sponsor's protocol ID
- CHUBX 2014/01
- Other IDs
- 2014-A01286-41
- Acronym
- SOCOG-MS
- Status last verified
- Mar 2017
- First submitted
- 5 Nov 2014
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Koubiyr I, Dulau-Metras C, Deloire M, Charre-Morin J, Saubusse A, Brochet B, Ruet A. Amygdala network reorganization mediates the theory of mind performances in multiple sclerosis. J Neurosci Res. 2022 Feb;100(2):537-550. doi: 10.1002/jnr.24986. Epub 2021 Nov 19.
PubMed 34796987Dulau C, Deloire M, Diaz H, Saubusse A, Charre-Morin J, Prouteau A, Brochet B. Social cognition according to cognitive impairment in different clinical phenotypes of multiple sclerosis. J Neurol. 2017 Apr;264(4):740-748. doi: 10.1007/s00415-017-8417-z. Epub 2017 Feb 20.
PubMed 28220288
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Social Cognition by Morphological and Functional Imaging in Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT02290587
- Acronym / sponsor ID
- SOCOG-MS / CHUBX 2014/01
- Conditions
- Multiple Sclerosis
- Keywords
- social cognitive, theory of mind, cognitive impairment, functional MRI, brain activation network
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- La Ligue Française Contre la Sclérose en Plaques
- Study start
- Nov 2015 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 14 Nov 2014 (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.
In recent years, studies have brought knowledge of the difficulties of social cognition in Multiple Sclerosis (MS). The brain tissue alteration at the origin of these difficulties in social cognition mechanisms remain poorly understood. Although recent behavioral studies indicated social disturbances in many of these patients, functional studies investigating specific theory of mind in MS are lacking. The use of new techniques for morphological and functional Magnetic Resonance Imaging (MRI) can identify brain activation networks, mapping the achievement and tissue integrity may be related to disorders of social cognition and cognitive. The investigators propose to study social cognition in MS patients using morphological and functional imaging to determine the mechanisms underlying phenomena such as cerebral compensation and its relationship with cognitive impairment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient | Experimental | Other: Brain MRI - Clinical and cognitive evaluation, Device: MRIMS diagnosis according to McDonald criteria (Polman et al., 2005). Relapsing-remitting MS (RRMS) according to Lublin et al. (1996); |
| Control | Experimental | Other: Brain MRI - Clinical and cognitive evaluation, Device: MRIhealthy subject |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Aged 18-59 years
- Right handed
- Fluent French speaker
- MS diagnosis according to McDonald criteria (Polman et al., 2005).
- Relapsing-remitting MS (RRMS) according to Lublin et al. (1996);
Key exclusion criteria (20 listed)
- Other progressive neurological disease;
- psychiatric comorbidity including severe depression according to Diagnostic and Statistical Manual-IV (DSM-IV),
- alcohol or other addiction to toxic,
- Expanded Disability Status Scale (EDSS) > 6; disabling visual or motor problems preventing participation to neuropsychological assessments,
- relapse since less than one month,
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 |
|---|---|---|
| Brain MRI - Clinical and cognitive evaluationNeuropsychological evaluation : * Questionnaire for depression and anxiety * Evaluation of executive functions * Evaluation of attention, information processing speed, verbal memory and working memory Theory of mind evaluation Clinical Evaluation MRI Evaluation : * morphological MRI * functional MRI with two tasks of theory of mind : eyes test and test of attribution of intention | Other | Control, Patient |
| MRI | Device | Control, Patient |
Primary outcome
Brain activation networks during MRI
Time frame: At inclusion (day 0)
To identify brain activation networks during the two paradigms of theory of mind and executive function in RRMS patients taking into account cognitive impairment.
2 secondary outcomes
Reduction of volume of deep brain structures and reduction of cortical thickness
Time frame: At inclusion (day 0)
White matter skeleton on Fractional Anisotropy (FA) maps established by voxel-based.
Time frame: At inclusion (day 0)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Results publication: PubMed 34796987Koubiyr I, Dulau-Metras C, Deloire M, Charre-Morin J, Saubusse A, Brochet B, Ruet A. Amygdala network reorganization mediates the theory of mind performances in multiple sclerosis. J Neurosci Res. 2022 Feb;100(2):537-550. doi: 10.1002/jnr.24986. Epub 2021 Nov 19.
- Results publication: PubMed 28220288Dulau C, Deloire M, Diaz H, Saubusse A, Charre-Morin J, Prouteau A, Brochet B. Social cognition according to cognitive impairment in different clinical phenotypes of multiple sclerosis. J Neurol. 2017 Apr;264(4):740-748. doi: 10.1007/s00415-017-8417-z. Epub 2017 Feb 20.
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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.
Bruno Brochet, Prof. principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain MRI - Clinical and cognitive evaluation and MRI in people with Multiple Sclerosis, run by University Hospital, Bordeaux 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 12 inclusion and 20 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: finished, as of the sponsor's last update on 14 May 2026. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Brain activation networks during MRI (time frame: At inclusion (day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02290587, which also lists 2 linked publications.
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 14 May 2026.