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Emotions in Multiple Sclerosis (RECODE)

Primary Purpose

Multiple Sclerosis

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Carrying out a tests and questionnaires battery
Sponsored by
Lille Catholic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Multiple Sclerosis focused on measuring Multiple sclerosis, Emotions recognition, Cognitive disorders

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts 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

Sites / Locations

  • Hôpital Saint-Vincent de PaulRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group : patients with multiple sclerosis

Control group : volunteers

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).
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).
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).
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")

Secondary Outcome Measures

California Verbal Learning Test (CVLT)
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.
Brief Visuo-spatial Memory Test (BVMT)
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.
Symbol Digit Modalities Test (SDMT)
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.
Stroop test
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.
Trail Making test
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.
Verbal fluency test
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.
Beck Depression Inventory (BDI)
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.
State Trait Anxiety Inventory Y-A (STAI Y-A)
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.
State Trait Anxiety Inventory Y-B (STAI Y-B)
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.
Toronto Alexithymia Scale-20 (TAS-20)
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.
Dot Probe Task
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.
Change in the electrodermal response during emotion recognition test
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.

Full Information

First Posted
March 16, 2021
Last Updated
June 21, 2023
Sponsor
Lille Catholic University
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1. Study Identification

Unique Protocol Identification Number
NCT04804787
Brief Title
Emotions in Multiple Sclerosis
Acronym
RECODE
Official Title
Emotions Recognition in Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 23, 2021 (Actual)
Primary Completion Date
December 23, 2024 (Anticipated)
Study Completion Date
December 23, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lille Catholic University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple sclerosis, Emotions recognition, Cognitive disorders

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group : patients with multiple sclerosis
Arm Type
Experimental
Arm Description
The experimental group will be constituted of patients with multiple sclerosis.
Arm Title
Control group : volunteers
Arm Type
Active Comparator
Arm 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
Intervention Type
Diagnostic Test
Intervention Name(s)
Carrying out a tests and questionnaires battery
Intervention Description
The attendees will carry out different questionnaires and tests to evaluate their potential cognitive disorders
Primary Outcome Measure Information:
Title
Emotion's valence
Description
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).
Time Frame
Day 0
Title
Emotion's intensity
Description
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).
Time Frame
Day 0
Title
Emotion recognition
Description
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).
Time Frame
Day 0
Title
Certainty's degree of answers
Description
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")
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
California Verbal Learning Test (CVLT)
Description
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.
Time Frame
Day 0
Title
Brief Visuo-spatial Memory Test (BVMT)
Description
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.
Time Frame
Day 0
Title
Symbol Digit Modalities Test (SDMT)
Description
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.
Time Frame
Day 0
Title
Stroop test
Description
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.
Time Frame
Day 0
Title
Trail Making test
Description
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.
Time Frame
Day 0
Title
Verbal fluency test
Description
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.
Time Frame
Dat 0
Title
Beck Depression Inventory (BDI)
Description
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.
Time Frame
At the unique experimental session
Title
State Trait Anxiety Inventory Y-A (STAI Y-A)
Description
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.
Time Frame
Day 0
Title
State Trait Anxiety Inventory Y-B (STAI Y-B)
Description
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.
Time Frame
Day 0
Title
Toronto Alexithymia Scale-20 (TAS-20)
Description
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.
Time Frame
Day 0
Title
Dot Probe Task
Description
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.
Time Frame
Day 0
Title
Change in the electrodermal response during emotion recognition test
Description
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.
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amélie Lansiaux, MD, PhD
Phone
03.20.22.52.69
Email
lansiaux.amelie@ghicl.net
First Name & Middle Initial & Last Name or Official Title & Degree
Valentine Duriez
Phone
03.20.22.59.02
Email
duriez.valentine@ghicl.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno Lenne
Organizational Affiliation
Hôpital Saint Vincent de Paul, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Saint-Vincent de Paul
City
Lille
ZIP/Postal Code
59000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruno Lenne

12. IPD Sharing Statement

Plan to Share IPD
No

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Emotions in Multiple Sclerosis

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