Clinical trial NCT06318923: Social and Moral Cognition in Multiple Sclerosis
Official title: Social and Moral Cognition in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
First posted: 2024-03-19
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Moral dilemma judgments
timeFrame: 3 hours
Secondary outcomes:
measure: Explicit time perspective inventory test
timeFrame: 3 hours
measure: Implicit time perspective inventory test
timeFrame: 3 hours
measure: Dot Probe Task
timeFrame: 3 hours
measure: Level of moral permissibility
timeFrame: 3 hours
measure: Level of emotional reactivity
timeFrame: 3 hours
measure: Moral relativity level
timeFrame: 3 hours
measure: Brief International Cognitive Assessment for Multiple Sclerosis
timeFrame: 3 hours
measure: The Beck Depression Inventory
timeFrame: 3 hours
measure: State-Trait Anxiety Inventory
timeFrame: 3 hours
measure: Toronto Alexithymia Scale (TAS)-20
timeFrame: 3 hours
measure: Empathy quotient-8 (EQ-8)
timeFrame: 3 hours
measure: Electrodermal response
timeFrame: 3 hours
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Saint-Vincent-de-Paul - Neurologie
city: Lomme
country: France
facility: Hôpital Saint-Philibert - Neurologie
Study officials:
affiliation: Catholic University of Lille Faculty of Letters and Humanities
name: Béatrice DEGRAEVE
role: PRINCIPAL_INVESTIGATOR
References: