Emotions in Multiple Sclerosis (RECODE)

Lille Catholic University

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Diagnostic Test: Carrying out a tests and questionnaires battery

Study type: Interventional

Funder types: Other

Identifiers

NCT04804787

RC-P00107

Details and patient eligibility

About

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.

Full 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).

Enrollment: 101 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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101 participants in 2 patient groups

Experimental group : patients with multiple sclerosis

Experimental group

Description:

The experimental group will be constituted of patients with multiple sclerosis.

Treatment:

Diagnostic Test: Carrying out a tests and questionnaires battery

Control group : volunteers

Active Comparator group

Description:

The control group will be constituted of healthy volunteers with the same characteristics concerning age, sex, education's level as experimental group's patients

Treatment:

Diagnostic Test: Carrying out a tests and questionnaires battery