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Study of Social Cognition by Morphological and Functional Imaging in Multiple Sclerosis Patients

Study of Social Cognition by Morphological and Functional Imaging in Multiple Sclerosis Patients

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02290587
Acronym
SOCOG-MS
Enrollment
35
Registered
2014-11-14
Start date
2015-11-01
Completion date
2017-03-01
Last updated
2026-05-14

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

Conditions

Multiple Sclerosis

Keywords

social cognitive, theory of mind, cognitive impairment, functional MRI, brain activation network

Brief 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. 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.

Interventions

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

DEVICEMRI

Sponsors

University Hospital, Bordeaux
Lead SponsorOTHER
La Ligue Française Contre la Sclérose en Plaques
CollaboratorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
Yes

Inclusion criteria

(patient group): * 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) * Being affiliated to health insurance Inclusion Criteria (healthy control): * 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

Exclusion criteria

(patient group): * 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, * 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

Design outcomes

Primary

MeasureTime frameDescription
Brain activation networks during MRIAt 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.

Secondary

MeasureTime frameDescription
Reduction of volume of deep brain structures and reduction of cortical thicknessAt inclusion (day 0)Correlation between social cognitive z scores and atrophy measures (reduction of volume of deep brain structures and reduction of cortical thickness).
White matter skeleton on Fractional Anisotropy (FA) maps established by voxel-based.At inclusion (day 0)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.

Countries

France

Contacts

PRINCIPAL_INVESTIGATORBruno Brochet, Prof.

University Hospital, Bordeaux

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 15, 2026