Multiple SclerosisCOSMOSNCT06318923
Social and Moral Cognition in Multiple Sclerosis
A study testing Socio-demographic questionnaire, moral judgment task, cognitive tests, psychoaffective assessment, MS questionnaire and MONTREAL COGNITIVE ASSESSMENT (MoCA) test in people with Multiple Sclerosis, run by Lille Catholic University at 2 sites in France.
Trial summary
Multiple Sclerosis (MS) is a chronic, progressive disease that affects young adults (aged between 20 and 40) and has a major impact on patients' quality of life. Cognitive disorders in MS are common, affecting 40-60% of patients. Among these disorders, the presence of social cognition disorders is common. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Socio-demographic questionnaire, moral judgment task, cognitive tests, psychoaffective assessment, MS questionnaire and MONTREAL COGNITIVE ASSESSMENT (MoCA) test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesFrance
- Study dates
- 19 Dec 2023to 30 Oct 2025
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men or women aged 18 to 55.
- Understanding and able to express themselves in French.
- Characteristics according to groups:
- MS patient group:
- relapsing-remitting form (RRMS)
- with EDSS ≤ 4
Show all 12Show fewer
- with no significant motor, cerebellar or somesthesic disorders of the upper limbs or visual disorders (specific EDSS parameter ≤ 2)
- absence of relapse in the last 6 weeks
- Control groups:
- absence of known global cognitive deterioration.
- Understanding and signing of the informed consent and information letter concerning participation in the study.
- Beneficiary of health insurance coverage.
Who cannot join
- People with previous neurological pathologies, head trauma with loss of consciousness, known psychiatric pathologies (excluding anxiety-depressive syndrome), serious general illnesses, perceptual or dysarthric disorders preventing verbal communication or reading,
- Severe cognitive impairment in MS patients, i.e. an SDMT score < -2.5 if the BICAMS battery is present in the patient's file and is less than 6 months old.
- Severe depressive syndrome, with a BDI-FS score > 10
- People with sensory disorders (visual and auditory) that interfere with neuropsychological testing;
- Major sensory disorders or cerebellar syndrome
- Sensory deficits (visual or auditory)
Show all 9Show fewer
- Treatment with psychotropic drugs
- Adults under guardianship, curatorship, persons deprived of liberty.
- Pregnant or breast-feeding women
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Hôpital Saint-Vincent-de-Paul - Neurologie
Lille
Béatrice DEGRAEVE
Laurent ZIKOS
- Recruiting
Hôpital Saint-Philibert - Neurologie
Lomme
Béatrice DEGRAEVE
Laurent ZIKOS
About this study
Multiple Sclerosis (MS) is a chronic, progressive disease that affects young adults (aged between 20 and 40) and has a major impact on patients' quality of life. Cognitive disorders in MS are common, affecting 40-60% of patients. Among these disorders, the presence of social cognition disorders is common. Within social cognition, the moral judgment has been an object of research in order to understand the determinants of moral decision-making: how and why individuals make moral choices with regard to a set of prescriptions and social norms. Compared to control subjects, MS patients show a decrease in moral permissiveness, as well as an increase in moral relativity and emotional reactivity. Thus, it would seem that MS patients issue more deontological choices (lower moral permissiveness). Given that these patients also exhibit empathy deficits and higher alexithymia, these patterns are surprising. Indeed, in other clinical populations, low empathic abilities and high alexithymia are linked to utilitarian rather than deontological moral judgments.
The objective of this project is to analyze the process of decision-making carried out by patients during moral dilemma situations in comparison with control individuals and verify whether the presence of a positivity bias could explain the more deontological choices made by some patients. Indeed, some work has shown that older individuals make more deontological moral judgments than younger adults. These results are also observed with young individuals when their future temporal perspectives have been experimentally constrained.
Read the detailed description
Among the explanatory factors of interest, motivational factors (future temporal perspectives and emergence of a positivity bias), as well as cognitive and affective factors (by means of neuropsychological assessment) and neurophysiological factors (by means of electrodermal response) will be investigated.
From a clinical point of view, a change in decision-making concerning choices with a strong emotional valence can have an impact on patients' daily lives and their course of care. Indeed, MS patients regularly have to make crucial choices about their treatment and care. A modification of decision-making patterns in these situations would represent a major challenge. A good understanding of these patterns will thus contribute to the development of appropriate management procedures to mitigate the impact on patients' daily lives.
- Conditions
- Multiple Sclerosis
- Being tested
- Socio-demographic questionnaire, moral judgment task, cognitive tests, psychoaffective assessment, MS questionnaire, MONTREAL COGNITIVE ASSESSMENT (MoCA) test
- Keywords
- Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Socio-demographic questionnaire, moral judgment task, cognitive tests, psychoaffective assessmentOther
The demographic questionnaire collects demographic information: gender, age, level of education, laterality, history of psychiatric or neurological disorders.
The moral judgment task consists in completing 20 vignettes of moral dilemmas. Cognitive disorders will be assessed using the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) battery. If the patient has taken the BICAMS battery recently (less than 6 months), and with no change in pathology since then, the results of these tests will be used in this study.
Affective disorders will be assessed using the following tests:
- The Beck Depression Inventory-Fast Screen (BDI-FS) to assess the level of depression,
- State trait anxiety inventory-Y (STAI-Y) to assess anxiety,
- Toronto Alexithymia Scale-20 (TAS-20)to assess alexithymia,
- The Empathy Quotient-8 (EQ-8) to assess participants' level of empathy,
- The Dot Probe Task to assess participants' emotional information processing style.
MS questionnaireOther
This questionnaire collects key information on the participant's pathology: clinical form, date of first symptoms, diagnosis, last attack, as well as latest EDSS and functional scores.
MONTREAL COGNITIVE ASSESSMENT (MoCA) testOther
The MoCA is a screening tool for neurocognitive impairment, designed primarily to detect milder impairment. The MoCA is a short-answer questionnaire that includes a number of tasks to be completed by the individual. The items assessed are grouped into six subsections: short-term memory, visuospatial skills, executive functions, attention, concentration, working memory, language and orientation in time and space. The tests proposed are often more complex than those found in the mini-mental state examination (MMSE).
| Study group | Role | What they receive |
|---|---|---|
| Multiple sclerosis patients | Other | MS patients with the relapsing-remitting form (RRMS) and Expanded Disability Status Scale (EDSS) ≤ 4 Receives: Other: Socio-demographic questionnaire, moral judgment task, cognitive tests, psychoaffective assessment; Other: MS questionnaire |
| Control participants | Other | Patients without global cognitive impairment Receives: Other: Socio-demographic questionnaire, moral judgment task, cognitive tests, psychoaffective assessment; Other: MONTREAL COGNITIVE ASSESSMENT (MoCA) test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Moral dilemma judgments
The measure will be carried out using a series of 20 vignettes.These vignettes present different scenarios of fictional moral dilemmas, and the subject must make a choice. This test therefore results in 20 binary measures, which can be separated according to the type of scenario.
In this task, for each vignette, the type of choice made is measured, along with levels of moral permissibility, subjective emotional reactivity and moral relativity.
For this scale:
Type of choice: binary yes/no (utilitarian/deontological) ; reflects an answer type (no better or worse outcome) Moral permissibility: Likert Scale from 0 to 10 ; reflects an answer type (no better or worse outcome) Subjective emotional reactivity : Likert Scale from 0 to 10 ; reflects an answer type (no better or worse outcome) Subjective emotional r
Measured: 3 hours
Secondary outcomes (12)
Explicit time perspective inventory test
Participants indicate, on scales ranging from 1 (not at all) to 5 (completely) their levels of agreement on 10 items assessing their future time perspective (e.g. "I plan to set many new goals for myself in the future"). A total score is extracted.
Measured: 3 hours
Implicit time perspective inventory test
Participants are presented with 20 fill-in-the-blank words. These words can be completed either with words referring to future time ("target words"), or with neutral words. The percentage of target words is extracted.
Measured: 3 hours
Dot Probe Task
This task allows us to assess whether individuals tend to pay more attention to positive or negative information. During the dot-probe task, participants are situated in front of a computer screen and asked to stare at a fixation cross on the center of the screen. Two stimuli, one of which is neutral and one of which is threatening, appear randomly on either side of the screen. The stimuli are presented for a predetermined length of time (most commonly 500ms), before a dot is presented in the location of one former stimulus. Participants are instructed to indicate the location of this dot as quickly as possible, either via keyboard or response box. Latency is measured automatically by the computer. The fixation cross appears again for several seconds and then the cycle is repeated. Quicker reaction time to the dot when it occurs in the previous location of a threatening stimulus is interpreted as vigilance to threat.
Measured: 3 hours
Level of moral permissibility
This test aims to measure to what extent the participant finds the proposed solution acceptable. For example: How acceptable do you find it to activate the switch in this situation? An 11-point Likert scale is displayed, ranging from "Not at all" to "Absolutely".
Measured: 3 hours
Level of emotional reactivity
This test aims to measure the individual's emotional (subjective) reaction to a moral dilemma. For example: What emotion does this situation arouse in you? An 11-point Likert scale is displayed, ranging from "None" to "Intense emotion".
Measured: 3 hours
Moral relativity level
This test aims to measure to what extent the participant feels this choice is consensual. For example: Out of 100 people who responded to this scenario, how many would answer as you do? An 11-point Likert scale is displayed below the question, ranging from 0% to 100%.
Measured: 3 hours
Brief International Cognitive Assessment for Multiple Sclerosis
This test enables the assessment of cognitive disorders. The battery's 3 component tests are as follows:
- California Verbal Learning Test (CVLT): This test is based on a master list of 16 words belonging to 4 distinct semantic categories . The list is presented 5 times, with the patient asked to recall it immediately after each presentation and after a 20-minute delay. A main score is extracted.
- Brief Visuo-spatial Memory Test (BVMT): This test involves 6 simple geometric drawings. 3 presentation/recall phases follow one another, during which the patient is shown the sheet for 10 seconds, followed by an immediate recall phase. A delayed recall phase (at 7 minutes) is also proposed. A main score is extracted.
- Symbol Digit Modalities Test (SDMT): a coding test in which the patient has 90 seconds to orally state the correspondence of digits (from 1 to 9) to 9 different symbols (matched according to a correspondence standard). The number of correct answers is measured.
Measured: 3 hours
The Beck Depression Inventory
This is a 21-question multiple-choice self-report inventory, for measuring the severity of depression.
When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is compared to a key to determine the depression's severity. The standard cut-off scores are as follows:
0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression. Higher total scores indicate more severe depressive symptoms.
Measured: 3 hours
State-Trait Anxiety Inventory
The State-Trait Anxiety Inventory is one of the first tests to assess both state and trait anxiety separately. Each type of anxiety has its own scale of 20 different questions that are scored.[10] Scores range from 20 to 80, with higher scores correlating with greater anxiety.
Measured: 3 hours
Toronto Alexithymia Scale (TAS)-20
The TAS-20 is a self-report scale that is comprised of 20 items. Items are rated using a 5-point Likert scale whereby 1 = strongly disagree and 5 = strongly agree. There are 5 items that are negatively keyed (items 4, 5, 10, 18 and 19). The total alexithymia score is the sum of responses to all 20 items, while the score for each subscale factor is the sum of the responses to that subscale. The TAS-20 uses cutoff scoring: equal to or less than 51 = non-alexithymia, equal to or greater than 61 = alexithymia. Scores of 52 to 60 = possible alexithymia.
Measured: 3 hours
Empathy quotient-8 (EQ-8)
This is an 8-item self-questionnaire. Subjects are asked to self-assess their level of empathy by positioning themselves, for each item, on a rating scale from 1 to 5 (1 = completely disagree and 5 = completely agree). The total score is analyzed.
Measured: 3 hours
Electrodermal response
During performance of the moral judgment task, an electrodermal response recording device will be installed via two electrodes placed on the participant's non-dominant hand to measure objective emotional reactivity. Individuals' signals are examined in relation to their own baseline levels (without stimuli, Baseline measure), which will serve as a reference for interpreting the signals obtained during the task.
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start19 Dec 2023
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Béatrice DEGRAEVE, Principal investigator, Catholic University of Lille Faculty of Letters and Humanities
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06318923
- Sponsor's protocol ID
- RC-P00117
- Acronym
- COSMOS
- Status last verified
- Mar 2024
- First submitted
- 12 Mar 2024
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social and Moral Cognition in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06318923
- Acronym / sponsor ID
- COSMOS / RC-P00117
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Study start
- 19 Dec 2023 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 19 Mar 2024 (actual)
- 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) is a chronic, progressive disease that affects young adults (aged between 20 and 40) and has a major impact on patients' quality of life. Cognitive disorders in MS are common, affecting 40-60% of patients. Among these disorders, the presence of social cognition disorders is common. Within social cognition, the moral judgment has been an object of research in order to understand the determinants of moral decision-making: how and why individuals make moral choices with regard to a set of prescriptions and social norms. Compared to control subjects, MS patients show a decrease in moral permissiveness, as well as an increase in moral relativity and emotional reactivity. Thus, it would seem that MS patients issue more deontological choices (lower moral permissiveness). Given that these patients also exhibit empathy deficits and higher alexithymia, these patterns are surprising. Indeed, in other clinical populations, low empathic abilities and high alexithymia are linked to utilitarian rather than deontological moral judgments.
The objective of this project is to analyze the process of decision-making carried out by patients during moral dilemma situations in comparison with control individuals and verify whether the presence of a positivity bias could explain the more deontological choices made by some patients. Indeed, some work has shown that older individuals make more deontological moral judgments than younger adults. These results are also observed with young individuals when their future temporal perspectives have been experimentally constrained.
Detailed description
Among the explanatory factors of interest, motivational factors (future temporal perspectives and emergence of a positivity bias), as well as cognitive and affective factors (by means of neuropsychological assessment) and neurophysiological factors (by means of electrodermal response) will be investigated.
From a clinical point of view, a change in decision-making concerning choices with a strong emotional valence can have an impact on patients' daily lives and their course of care. Indeed, MS patients regularly have to make crucial choices about their treatment and care. A modification of decision-making patterns in these situations would represent a major challenge. A good understanding of these patterns will thus contribute to the development of appropriate management procedures to mitigate the impact on patients' daily lives.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multiple sclerosis patients | Other | Other: Socio-demographic questionnaire, moral judgment task, cognitive tests, psychoaffective assessment, Other: MS questionnaireMS patients with the relapsing-remitting form (RRMS) and Expanded Disability Status Scale (EDSS) ≤ 4 |
| Control participants | Other | Other: Socio-demographic questionnaire, moral judgment task, cognitive tests, psychoaffective assessment, Other: MONTREAL COGNITIVE ASSESSMENT (MoCA) testPatients without global cognitive impairment |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Men or women aged 18 to 55.
- Understanding and able to express themselves in French.
- Characteristics according to groups:
- MS patient group:
- Control groups:
Key exclusion criteria (9 listed)
- People with previous neurological pathologies, head trauma with loss of consciousness, known psychiatric pathologies (excluding anxiety-depressive syndrome), serious general illnesses, perceptual or dysarthric disorders preventing verbal communication or reading,
- Severe cognitive impairment in MS patients, i.e. an SDMT score < -2.5 if the BICAMS battery is present in the patient's file and is less than 6 months old.
- Severe depressive syndrome, with a BDI-FS score > 10
- People with sensory disorders (visual and auditory) that interfere with neuropsychological testing;
- Major sensory disorders or cerebellar syndrome
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 |
|---|---|---|
| Socio-demographic questionnaire, moral judgment task, cognitive tests, psychoaffective assessmentThe demographic questionnaire collects demographic information: gender, age, level of education, laterality, history of psychiatric or neurological disorders. The moral judgment task consists in completing 20 vignettes of moral dilemmas. Cognitive disorders will be assessed using the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) battery. If the patient has taken the BICAMS battery recently (less than 6 months), and with no change in pathology since then, the results of these tests will be used in this study. Affective disorders will be assessed using the following tests: * The Beck Depression Inventory-Fast Screen (BDI-FS) to assess the level of depression, * State trait anxiety inventory-Y (STAI-Y) to assess anxiety, * Toronto Alexithymia Scale-20 (TAS-20)to assess alexithymia, * The Empathy Quotient-8 (EQ-8) to assess participants' level of empathy, * The Dot Probe Task to assess participants' emotional information processing style. | Other | Control participants, Multiple sclerosis patients |
| MS questionnaireThis questionnaire collects key information on the participant's pathology: clinical form, date of first symptoms, diagnosis, last attack, as well as latest EDSS and functional scores. | Other | Multiple sclerosis patients |
| MONTREAL COGNITIVE ASSESSMENT (MoCA) testThe MoCA is a screening tool for neurocognitive impairment, designed primarily to detect milder impairment. The MoCA is a short-answer questionnaire that includes a number of tasks to be completed by the individual. The items assessed are grouped into six subsections: short-term memory, visuospatial skills, executive functions, attention, concentration, working memory, language and orientation in time and space. The tests proposed are often more complex than those found in the mini-mental state examination (MMSE). | Other | Control participants |
Primary outcome
Moral dilemma judgments
Time frame: 3 hours
The measure will be carried out using a series of 20 vignettes.These vignettes present different scenarios of fictional moral dilemmas, and the subject must make a choice. This test therefore results in 20 binary measures, which can be separated according to the type of scenario. In this task, for each vignette, the type of choice made is measured, along with levels of moral permissibility, subjective emotional reactivity and moral relativity. For this scale: Type of choice: binary yes/no (utilitarian/deontological) ; reflects an answer type (no better or worse outcome) Moral permissibility: Likert Scale from 0 to 10 ; reflects an answer type (no better or worse outcome) Subjective emotional reactivity : Likert Scale from 0 to 10 ; reflects an answer type (no better or worse outcome) Subjective emotional r
12 secondary outcomes
Explicit time perspective inventory test
Time frame: 3 hours
Implicit time perspective inventory test
Time frame: 3 hours
Dot Probe Task
Time frame: 3 hours
Level of moral permissibility
Time frame: 3 hours
Level of emotional reactivity
Time frame: 3 hours
Moral relativity level
Time frame: 3 hours
Brief International Cognitive Assessment for Multiple Sclerosis
Time frame: 3 hours
The Beck Depression Inventory
Time frame: 3 hours
State-Trait Anxiety Inventory
Time frame: 3 hours
Toronto Alexithymia Scale (TAS)-20
Time frame: 3 hours
Empathy quotient-8 (EQ-8)
Time frame: 3 hours
Electrodermal response
Time frame: 3 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Béatrice DEGRAEVE principal investigator
Catholic University of Lille Faculty of Letters and Humanities
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Socio-demographic questionnaire, moral judgment task, cognitive tests, psychoaffective assessment, MS questionnaire and MONTREAL COGNITIVE ASSESSMENT (MoCA) test in people with Multiple Sclerosis, run by Lille Catholic University at 2 sites 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 12 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie Paule LEBITASY (03.20.22.57.41, Lebitasy.Marie-Paule@ghicl.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Moral dilemma judgments (time frame: 3 hours). 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 20 Mar 2024; AzTrials last refreshed its copy on 31 Oct 2026.