Evaluation and Neural Basis of Communication in Patients With Multiple Sclerosis

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases Neuropsychology Psychological Therory Social Cognition Theory of Mind

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pôle Saint Hélier

Rennes, Brittany Region, 35000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive evaluation

Other

Primary outcomes

conversation test

Time frame: fist day of the assessment

The objective of this task is to assess the verbal communication skills of MS patients in a 10-minute natural conversation (various conversation topics appropriated to the participant's age will be inserted in the conversation). Different performance indexes will be analyzed in this task: amount of verbal exchanges between both interlocutors (number of turn-taking and statements), adjustment to the examiner's requests, topic changes and topic continuity. With the use of the validated observation grid ("protocole Montréal d'évaluation de la Communication"), it will be possible to measure the frequency of occurrence or intensity of communicative behaviours
indirect langage comprehension

Time frame: second day of the assesment

This computer-based task assesses the MS patients' ability to understand indirect statements. Three forms of indirect language will be tested in this protocol: indirect requests, idiomatic expressions and sarcasms (12 items per language forms). Each item consists of a story (3 pictures with an audio-recorded text) where at least 2 characters appear in everyday life situations. The participant has to choose the end of the story from the four options (pragmatic evaluation) and to justify his/her answer (metapragmatic evaluation). The performance indexes used are the total number of correct answers, the total number of correct answers by linguistic form and the number of central justifications by correct answer, showing metapragmatic knowledge.

Sponsors and collaborators

Lead sponsor

Pôle Saint Hélier

Other

Collaborators

Rennes University Hospital
University Hospital, Angers
Université Européenne de Bretagne

Registry information

Acronym: COGNISEP

Important dates

Study start: 2015
Primary completion: 2019
Study completion: 2020
First posted: Jan 11, 2016
Registry last updated: Jul 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed