Clinical trial NCT02652013: Evaluation and Neural Basis of Communication in Patients With Multiple Sclerosis
Official title: Evaluation and Neural Basis of Communication in Patients With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Social Cognition
Neuropsychology
Psychological Therory
Theory of Mind
Lead sponsor: Pôle Saint Hélier
Sponsor class: OTHER
Collaborators: name: Rennes University Hospital
name: University Hospital, Angers
name: Université Européenne de Bretagne
First posted: 2016-01-11
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Multiple sclerosis (MS) progressively leads to an increasing level of disability. That's why individuals faced with this chronic disease whose progression is unpredictable have to mobilize all their available resources. As a result, management of interpersonal relationships appears to be a key issue in adjustment to situations.

Although knowledge on cognitive abnormalities in MS has been growing in recent years, there is a lack of research about social behaviour regulation skills. The few studies conducted in this field are mainly interested in emotional processing (emotional facial recognition and empathy) and skills mentalizing (theory of mind) that appear disturbed in MS.

While some recent studies touch on the issue of the contextual analysis of language (that is to say, the social use of language) in MS, their assessment on a wide range of pragamtic skills has never been studied. However, the pragmatic aspects of language are known to play a major role in social adjustment.

This project has three main objectives : (1) to increase general knowledge of deficits in communication and in social cognition in patients with MS, (2) to propose new leads for the evaluation of these disorders and (3) to contribute to increasing knowledge of neural basis of communication and social cognition.

In order to address those objectives, the assessment will be focused on many various pragmatics skills : conversation, indirect language comprehension (indirect questions, idiomatic expressions, sarcasm) and metapragmatic knowledge in a population of 40 RR-MS patients. Those patients' performances will be compared to a group of healthy matched control subjects, potential relationships between pragmatic abilities, other aspects of social cognition (theory of mind and processing of emotional stimuli), cognitive functioning, psycho-behavioural aspects and the characteristics of the disease will be explore.

Social cognition tasks have been selected for their dynamic and ecologic aspects in order to match natural social interaction.

Finally, communication consideration, cognitive and cerebral skills of patients with MS will contribute to increasing knowledge of the neural basis of social cognition.


Eligibility criteria: Inclusion Criteria:

Exclusion Criteria:

* Relapsing-remitting form as defined by the Mc Donald's Committee criteria (2005).
* EDSS between 0 and 5.5, out of relapses
* French mother tongue or having been schooled in France
* No disorders of formal language comprehension
* Not having participated to a similar protocol within the 9 months preceding the inclusion

Primary outcomes:
measure: conversation test
timeFrame: fist day of the assessment
measure: indirect langage comprehension
timeFrame: second day of the assesment
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: Pôle Saint Hélier
state: Bretagne
Study officials:
affiliation: Pôle Saint Hélier
name: Philippe Gallien, doctor
role: PRINCIPAL_INVESTIGATOR
References: