Social and Moral Cognition in Multiple Sclerosis (COSMOS)

Lille Catholic University

Status: Enrolling

Conditions: Multiple Sclerosis

Treatments: Other: MS questionnaire; Other: Socio-demographic questionnaire, moral judgment task, cognitive tests, psychoaffective assessment; Other: MONTREAL COGNITIVE ASSESSMENT (MoCA) test

Study type: Interventional

Funder types: Other

Identifiers

NCT06318923

RC-P00117

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Multiple sclerosis patients

Other group

Description:

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

Treatment:

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

Other: MS questionnaire

Control participants

Other group

Description:

Patients without global cognitive impairment

Treatment:

Other: MONTREAL COGNITIVE ASSESSMENT (MoCA) test

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