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Completed

NCT Number: NCT04804787

Emotions in Multiple Sclerosis

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Saint-Vincent de Paul

Lille, 59000, France

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Carrying out a tests and questionnaires battery

Diagnostic Test

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

Primary outcomes

  1. Emotion's valence

    Time frame: Day 0

    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).

  2. Emotion's intensity

    Time frame: Day 0

    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).

  3. Emotion recognition

    Time frame: Day 0

    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).

  4. Certainty's degree of answers

    Time frame: Day 0

    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")

Secondary outcomes

  1. California Verbal Learning Test (CVLT)

    Time frame: Day 0

    Learning test of a 16 words list belonging to 4 distinct semantic categories (flowers, fish, clothes, fruit). The list is presented 5 times to the patient who must remember it immediately after each presentation, after the presentation of a second interfering list and after a 20-minute delay. A main score is extracted determining how many errors are made in each learning task.

  2. Brief Visuo-spatial Memory Test (BVMT)

    Time frame: Day 0

    Learning test in episodic visuo-spatial memory of 6 simple geometrical drawings. This test presents 3 presentation phases during which the sheet containing the 6 drawings is presented to the participant for 10 seconds, followed by an immediate recall phase (free hand reproduction of the drawings). A delayed recall phase (at 7 minutes) and a delayed recognition phase (among 12 distractors) is also proposed. A main score is extracted.

  3. Symbol Digit Modalities Test (SDMT)

    Time frame: Day 0

    Coding test in which the patient has 90 seconds to state orally the correspondence of numbers (from 1 to 9) to 9 different symbols (matched according to a matching standard). The correct answers number is measured.

  4. Stroop test

    Time frame: Day 0

    The Stroop test is used to evaluate executive functions, especially inhibition abilities and sensitivity to interference. This test offers 3 situations in which performance is measured by the time taken by the patient for each situation and the number of uncorrected errors.

  5. Trail Making test

    Time frame: Day 0

    The Trail Making Test is used to evaluate executive functions especially the cognitive flexibility abilities. The subject's performance is evaluated by the time taken by the subject, the total number of errors and the number of perseveration errors.

  6. Verbal fluency test

    Time frame: Dat 0

    The verbal fluency test evaluates executive functions, and more specifically the spontaneous flexibility's abilities. The performance is evaluated by the number of different words cited.

  7. Beck Depression Inventory (BDI)

    Time frame: At the unique experimental session

    The Beck Depression Inventory is used to assess depressive disorders. It is a 13-items self-questionnaire rated from 0 (no problem) to 3 (maximum severity of this symptom). The depression's severity is assessed by classifying the total score into 3 levels of intensity: <3: Normal; 3-8: Borderline; >8: Depressed.

  8. State Trait Anxiety Inventory Y-A (STAI Y-A)

    Time frame: Day 0

    The STAI Y-A anxiety scale (state anxiety) is used to assess the attendees state anxiety's level. The anxiety's severity is measured by 5 intensity's levels : 35: Very low anxiety; 36-45: Low anxiety; 46-55: Moderate anxiety; 56-65: High anxiety; > 65: Very high anxiety.

  9. State Trait Anxiety Inventory Y-B (STAI Y-B)

    Time frame: Day 0

    The STAI Y-B anxiety scale (trait anxiety) is used to assess the attendees trait anxiety's level. The anxiety's severity is measured by 5 intensity's levels : 35: Very low anxiety; 36-45: Low anxiety; 46-55: Moderate anxiety; 56-65: High anxiety; > 65: Very high anxiety.

  10. Toronto Alexithymia Scale-20 (TAS-20)

    Time frame: Day 0

    The TAS-20 is used to assess the attendees alexithymia's level. The alexithymic syndrome's severity is measured in 4 intensity's levels based on responses to 20 items: 0-51: no alexithymia; 52-60: mild alexithymia; > 60: severe alexithymia.

  11. Dot Probe Task

    Time frame: Day 0

    Through the Dot Probe Task, it is possible to find out whether participants tend to focus their attention on positive or negative information. The reaction time to complete the task and the accuracy of the response are measured.

  12. Change in the electrodermal response during emotion recognition test

    Time frame: Day 0

    Before the emotion recognition test a first resting measurement of the electrodermal response is performed. Then, the attendee electrodermal response will be recorded during the test for each emotional stimulus. At the end of the test, a second resting measurement of the electrodermal response will be performed. The signals obtained during the task will be compared with the attendee resting signals.

Sponsors and collaborators

Lead sponsor

Lille Catholic University

Other

Registry information

Official study title

Emotions Recognition in Multiple Sclerosis

Acronym: RECODE

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Mar 18, 2021
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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