Clinical trial NCT04804787: Emotions in Multiple Sclerosis
Official title: Emotions Recognition in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis
Emotions recognition
Cognitive disorders
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
First posted: 2021-03-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1 experimental group composed of patients with multiple sclerosis

1 control group composed of volunteers matched in gender, age, and education's level with the experimental group
Primary purpose: DIAGNOSTIC

Brief summary: Through this study, a group composed of multiple sclerosis patients will be compared to a healthy volunteers group to determine if the positive emotions recognitions is preserved in the first group.

Detailed description: Different studies have highlighted the specific deficiency concerning emotions recognition in multiple sclerosis. Patients with multiple sclerosis are reported to have more difficulty recognising negative emotions, especially anger and fear.

In this context, RECODE study has a twofold objective:

* To determine whether the positive emotions recognition remains preserved by combining behavioural and neurophysiological measures (electrodermal activity).
* To study this disorder's etiology through a comparison between a multiple sclerosis patient group and a control group (matched in sex, age, and education's level).

Eligibility criteria: Inclusion Criteria:

* Male or female between 18 and 55 years old.
* Understand and able to express themselves in French.
* EXPERIMENTAL GROUP :
* Relapsing-remitting form (RRMS)
* With an EDSS \< 4 (Expanded Disability Status Scale)
* No significant motor, cerebellar or somatosensory disorders of the upper limbs or visual disorders (EDSS specific parameter \<2)
* No flare-up in the last 6 weeks
* No corticosteroids taken in the last 4 weeks
* CONTROL GROUP :
* Lack of global cognitive deterioration (according to Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) standards).
* Gender, age and education level matching to the multiple sclerosis patients
* Understanding and signing the informed consent and information letter regarding participation in the study.
* Benefiting from health insurance coverage.

Exclusion Criteria:

* Persons with previous neurological pathologies, head trauma with loss of consciousness, psychiatric pathologies, serious general affections, perceptive or dysarthric disorders preventing verbal communication or reading,
* People with sensory disorders (visual and auditory) that interfere with the performance of neuropsychological tests;
* Treatment with psychotropic drugs (except benzodiazepines and hypnotics).
* Refusal to participate after clear and fair information about the study.
* Major persons under guardianship, under judicial protection, persons deprived of liberty.
* Pregnant or breastfeeding women

Primary outcomes:
measure: Emotion's valence
timeFrame: Day 0
measure: Emotion's intensity
timeFrame: Day 0
measure: Emotion recognition
timeFrame: Day 0
measure: Certainty's degree of answers
timeFrame: Day 0
Secondary outcomes:
measure: California Verbal Learning Test (CVLT)
timeFrame: Day 0
measure: Brief Visuo-spatial Memory Test (BVMT)
timeFrame: Day 0
measure: Symbol Digit Modalities Test (SDMT)
timeFrame: Day 0
measure: Stroop test
timeFrame: Day 0
measure: Trail Making test
timeFrame: Day 0
measure: Verbal fluency test
timeFrame: Dat 0
measure: Beck Depression Inventory (BDI)
timeFrame: At the unique experimental session
measure: State Trait Anxiety Inventory Y-A (STAI Y-A)
timeFrame: Day 0
measure: State Trait Anxiety Inventory Y-B (STAI Y-B)
timeFrame: Day 0
measure: Toronto Alexithymia Scale-20 (TAS-20)
timeFrame: Day 0
measure: Dot Probe Task
timeFrame: Day 0
measure: Change in the electrodermal response during emotion recognition test
timeFrame: Day 0
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Saint-Vincent de Paul
Study officials:
affiliation: Hôpital Saint Vincent de Paul, Lille
name: Bruno Lenne
role: PRINCIPAL_INVESTIGATOR
References: