search
Back to results

Evaluation and Neural Basis of Communication in Patients With Multiple Sclerosis (COGNISEP)

Primary Purpose

Multiple Sclerosis, Social Cognition, Neuropsychology

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
cognitive evaluation
Sponsored by
Pôle Saint Hélier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Multiple Sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Pôle Saint Hélier

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

40 patients with multiple sclerosis

40 healthy subjects

Arm Description

The study sample will consist of 40 patients with multiple sclerosis. MS patients and control subjects will be recruited on the Rennes (Centre Hospitalier Universitaire and Pôle de Médecine Physique et de Réadaptation Saint-Hélier) and Angers sites (Centre Hospitalier Universitaire) participating in COGNISEP project

All the performance of the 40 MS patients will be compared to 40 control subjects matched in age, gender and sociocultural level. Subjects with a history of neurological and psychiatric condition or substance abuse will be excluded from the study. Control subjects will receive an honorary as a token for their time.

Outcomes

Primary Outcome Measures

conversation test
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
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.

Secondary Outcome Measures

Full Information

First Posted
January 6, 2016
Last Updated
July 24, 2020
Sponsor
Pôle Saint Hélier
Collaborators
Rennes University Hospital, University Hospital, Angers, Université Européenne de Bretagne
search

1. Study Identification

Unique Protocol Identification Number
NCT02652013
Brief Title
Evaluation and Neural Basis of Communication in Patients With Multiple Sclerosis
Acronym
COGNISEP
Official Title
Evaluation and Neural Basis of Communication in Patients With Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
December 2015 (Actual)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
January 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pôle Saint Hélier
Collaborators
Rennes University Hospital, University Hospital, Angers, Université Européenne de Bretagne

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Social Cognition, Neuropsychology, Psychological Therory, Theory of Mind

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
40 patients with multiple sclerosis
Arm Type
Experimental
Arm Description
The study sample will consist of 40 patients with multiple sclerosis. MS patients and control subjects will be recruited on the Rennes (Centre Hospitalier Universitaire and Pôle de Médecine Physique et de Réadaptation Saint-Hélier) and Angers sites (Centre Hospitalier Universitaire) participating in COGNISEP project
Arm Title
40 healthy subjects
Arm Type
Other
Arm Description
All the performance of the 40 MS patients will be compared to 40 control subjects matched in age, gender and sociocultural level. Subjects with a history of neurological and psychiatric condition or substance abuse will be excluded from the study. Control subjects will receive an honorary as a token for their time.
Intervention Type
Other
Intervention Name(s)
cognitive evaluation
Primary Outcome Measure Information:
Title
conversation test
Description
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
Time Frame
fist day of the assessment
Title
indirect langage comprehension
Description
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.
Time Frame
second day of the assesment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Gallien, doctor
Organizational Affiliation
Pôle Saint Hélier
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pôle Saint Hélier
City
Rennes
State/Province
Bretagne
ZIP/Postal Code
35000
Country
France

12. IPD Sharing Statement

Learn more about this trial

Evaluation and Neural Basis of Communication in Patients With Multiple Sclerosis

We'll reach out to this number within 24 hrs