Social and Moral Cognition in Multiple Sclerosis

NCT ID: NCT06318923

Last Updated: 2024-03-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-19
• Study Completion Date: 2025-10-30

Brief 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. 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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Multiple sclerosis patients

MS patients with the relapsing-remitting form (RRMS) and Expanded Disability Status Scale (EDSS) ≤ 4

Group Type: OTHER

Socio-demographic questionnaire, moral judgment task, cognitive tests, psychoaffective assessment

Intervention Type: OTHER

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 questionnaire

Intervention Type: OTHER

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.

Control participants

Patients without global cognitive impairment

Group Type: OTHER

Socio-demographic questionnaire, moral judgment task, cognitive tests, psychoaffective assessment

Intervention Type: OTHER

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.

MONTREAL COGNITIVE ASSESSMENT (MoCA) test

Intervention Type: OTHER

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).

Interventions

Socio-demographic questionnaire, moral judgment task, cognitive tests, psychoaffective assessment

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.

Intervention Type: OTHER

MS questionnaire

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.

Intervention Type: OTHER

MONTREAL COGNITIVE ASSESSMENT (MoCA) test

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).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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
• 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.

Exclusion Criteria

• 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)
• Treatment with psychotropic drugs
• Adults under guardianship, curatorship, persons deprived of liberty.
• Pregnant or breast-feeding women

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lille Catholic University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Béatrice DEGRAEVE

Role: PRINCIPAL_INVESTIGATOR

Catholic University of Lille Faculty of Letters and Humanities

Locations

Hôpital Saint-Vincent-de-Paul - Neurologie

Lille, , France

Site Status: RECRUITING

Hôpital Saint-Philibert - Neurologie

Lomme, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Marie Paule LEBITASY

Role: CONTACT

Lebitasy.Marie-Paule@ghicl.net

03.20.22.57.41

Audrey TOIA

Role: CONTACT

toia.audrey@ghicl.net

03.20.22.57.33

Facility Contacts

Béatrice DEGRAEVE

Role: primary

Béatrice DEGRAEVE

Role: primary

Other Identifiers

RC-P00117

Identifier Type: -

Identifier Source: org_study_id