Status:
COMPLETED
Study of Social Cognition by Morphological and Functional Imaging in Multiple Sclerosis Patients
Lead Sponsor:
University Hospital, Bordeaux
Collaborating Sponsors:
La Ligue Française Contre la Sclérose en Plaques
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-59 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- Exclusion Criteria (healthy control):
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2017
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT02290587
Start Date
November 1 2015
End Date
March 1 2017
Last Update
April 4 2017
Active Locations (1)
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1
CHU de Bordeaux
Bordeaux, France, 33000