Multiple SclerosisRECODENCT04804787
Emotions in Multiple Sclerosis
A study testing Carrying out a tests and questionnaires battery in people with Multiple Sclerosis, run by Lille Catholic University at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Carrying out a tests and questionnaires battery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteFrance
- Study dates
- 23 Jun 2021to 25 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Emotions Recognition 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.
Read the 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).
- Conditions
- Multiple Sclerosis
- Being tested
- Carrying out a tests and questionnaires battery
- Keywords
- Multiple sclerosis, Emotions recognition, Cognitive disorders
- Medical subject headings
- Multiple Sclerosis, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carrying out a tests and questionnaires batteryDiagnostic test
The attendees will carry out different questionnaires and tests to evaluate their potential cognitive disorders
| Study group | Role | What they receive |
|---|---|---|
| Experimental group : patients with multiple sclerosis | Experimental | The experimental group will be constituted of patients with multiple sclerosis. Receives: 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 Receives: Diagnostic Test: Carrying out a tests and questionnaires battery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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")
Measured: Day 0
Secondary outcomes (12)
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.
Measured: Day 0
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.
Measured: Day 0
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.
Measured: Day 0
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.
Measured: Day 0
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.
Measured: Day 0
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.
Measured: Dat 0
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.
Measured: At the unique experimental session
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.
Measured: Day 0
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.
Measured: Day 0
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.
Measured: Day 0
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.
Measured: Day 0
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.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start23 Jun 2021
- Primary completion25 Feb 2025
- Study completion25 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruno Lenne, Principal investigator, Hôpital Saint Vincent de Paul, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04804787
- Sponsor's protocol ID
- RC-P00107
- Acronym
- RECODE
- Status last verified
- Dec 2025
- First submitted
- 16 Mar 2021
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotions Recognition in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04804787
- Acronym / sponsor ID
- RECODE / RC-P00107
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, Emotions recognition, Cognitive disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Study start
- 23 Jun 2021 (actual)
- Primary completion
- 25 Feb 2025 (actual)
- Study completion
- 25 Feb 2025 (actual)
- First posted
- 18 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Experimental group : patients with multiple sclerosis | Experimental | Diagnostic Test: Carrying out a tests and questionnaires batteryThe experimental group will be constituted of patients with multiple sclerosis. |
| Control group : volunteers | Active comparator | Diagnostic Test: Carrying out a tests and questionnaires batteryThe control group will be constituted of healthy volunteers with the same characteristics concerning age, sex, education's level as experimental group's patients |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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)
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carrying out a tests and questionnaires batteryThe attendees will carry out different questionnaires and tests to evaluate their potential cognitive disorders | Diagnostic test | Control group : volunteers, Experimental group : patients with multiple sclerosis |
Primary outcome
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).
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).
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).
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")
12 secondary outcomes
California Verbal Learning Test (CVLT)
Time frame: Day 0
Brief Visuo-spatial Memory Test (BVMT)
Time frame: Day 0
Symbol Digit Modalities Test (SDMT)
Time frame: Day 0
Stroop test
Time frame: Day 0
Trail Making test
Time frame: Day 0
Verbal fluency test
Time frame: Dat 0
Beck Depression Inventory (BDI)
Time frame: At the unique experimental session
State Trait Anxiety Inventory Y-A (STAI Y-A)
Time frame: Day 0
State Trait Anxiety Inventory Y-B (STAI Y-B)
Time frame: Day 0
Toronto Alexithymia Scale-20 (TAS-20)
Time frame: Day 0
Dot Probe Task
Time frame: Day 0
Change in the electrodermal response during emotion recognition test
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruno Lenne principal investigator
Hôpital Saint Vincent de Paul, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carrying out a tests and questionnaires battery in people with Multiple Sclerosis, run by Lille Catholic University at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emotion's valence (time frame: Day 0). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.