Multiple SclerosisCOGNISEPNCT02652013
Evaluation and Neural Basis of Communication in Patients With Multiple Sclerosis
A study testing cognitive evaluation in people with Multiple Sclerosis and Social Cognition, run by Pôle Saint Hélier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Social Cognition, Neuropsychology
- What is being tested?
- cognitive evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2015to Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Multiple Sclerosis, Social Cognition, Neuropsychology, Psychological Therory, Theory of Mind
- Being tested
- cognitive evaluation
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive evaluationOther
| Study group | Role | What they receive |
|---|---|---|
| 40 patients with multiple sclerosis | Experimental | 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 Receives: Other: cognitive evaluation |
| 40 healthy subjects | Other | 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. Receives: Other: cognitive evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: fist day of the assessment
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.
Measured: second day of the assesment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2016 (estimated)
- Study startDec 2015
- Primary completionDec 2019
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pôle Saint Hélier
- Sponsor type
- University, hospital or other
- Collaborators
- Rennes University Hospital, University Hospital, Angers, Université Européenne de Bretagne
- Responsible party
- Principal investigator, Philippe Gallien, Pôle Saint Hélier
- Investigators
- Philippe Gallien, doctor, Principal investigator, Pôle Saint Hélier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02652013
- Sponsor's protocol ID
- 2015-A00624-45
- Acronym
- COGNISEP
- Status last verified
- Jul 2020
- First submitted
- 6 Jan 2016
- Last updated
- 27 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Neural Basis of Communication in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02652013
- Acronym / sponsor ID
- COGNISEP / 2015-A00624-45
- Conditions
- Multiple Sclerosis, Social Cognition, Neuropsychology, Psychological Therory, Theory of Mind
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Pôle Saint HélierUniversity, hospital or other
- Collaborators
- Rennes University Hospital, University Hospital, Angers, Université Européenne de Bretagne
- Study start
- Dec 2015 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 11 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 40 patients with multiple sclerosis | Experimental | Other: cognitive evaluationThe 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 |
| 40 healthy subjects | Other | Other: cognitive evaluationAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognitive evaluation | Other | 40 healthy subjects, 40 patients with multiple sclerosis |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Gallien, doctor principal investigator
Pôle Saint Hélier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive evaluation in people with Multiple Sclerosis and Social Cognition, run by Pôle Saint Hélier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
conversation test (time frame: fist day of the assessment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2020.