Emotions in Multiple Sclerosis

NCT04804787 | Completed

• 1 other identifier: RC-P00107
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis; Emotions recognition; Cognitive disorders

Outcome Measures

Primary Outcomes (4)

• Emotion's valence

  Through the emotion recognition test, the attendees will have to evaluate the emotion's valence conveyed by the stimuli on a scale ranging from 1 (the emotion conveyed is negative) to 10 (the emotion conveyed is positive).

  Day 0

• Emotion's intensity

  Through the emotion recognition test, the attendees will have to evaluate the emotion's intensity conveyed by the stimuli on a scale ranging from 1 (the emotion conveyed is not very intense) to 10 (the emotion conveyed is very intense).

  Day 0

• Emotion recognition

  Comparison of the answers obtained to the recognition question "In your opinion what is the emotion conveyed by this extract/face" in both groupsThrough the emotion recognition test, the attendees will have to evaluate the emotion perceived among 6 basic emotions (anger, disgust, joy, fear, surprise, sadness) and 14 complex emotions (benevolence, disappointment, boredom, enthusiasm, mischief, pride, frustration, shame, hostility, worry, interest, jealousy, sorrow, sneakiness).

  Day 0

• Certainty's degree of answers

  Certainty's degree of the attendees answers to the recognition question on a scale from 1 ("I am not at all certain of my answer") to 10 ("I am quite certain of my answer")

  Day 0

Secondary Outcomes (12)

• California Verbal Learning Test (CVLT)

  Day 0

• Brief Visuo-spatial Memory Test (BVMT)

  Day 0

• Symbol Digit Modalities Test (SDMT)

  Day 0

• Stroop test

  Day 0

• Trail Making test

  Day 0

Study Arms (2)

Experimental group : patients with multiple sclerosis

EXPERIMENTAL

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

Diagnostic Test: Carrying out a tests and questionnaires battery

Control group : volunteers

ACTIVE COMPARATOR

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

Diagnostic Test: Carrying out a tests and questionnaires battery

Interventions

Carrying out a tests and questionnaires battery DIAGNOSTIC_TEST

The attendees will carry out different questionnaires and tests to evaluate their potential cognitive disorders

Control group : volunteers; Experimental group : patients with multiple sclerosis

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Lille Catholic University: lead

Study Sites (1)

Hôpital Saint-Vincent de Paul

Lille, 59000, France

Location

MeSH Terms

Conditions

Multiple Sclerosis; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Bruno Lenne

  Hôpital Saint Vincent de Paul, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: March 18, 2021
• Study Start: June 23, 2021
• Primary Completion: February 25, 2025
• Study Completion: February 25, 2025
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)