Multiple SclerosisTDE-SEPNCT04806217
Nature of the Link Between Executive Functions and Theory of Mind in Multiple Sclerosis
A study testing Theory of Mind in people with Multiple Sclerosis, run by Lille Catholic University.
Trial summary
The purpose of this study is to explore inhibition and inference abilities in The Theory of Mind skills in multiple sclerosis patients using the Theory of Mind task. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Theory of Mind
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2022to 1 Jan 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People :
- With multiple sclerosis
- Age ≥ 18 years old
- Not objecting to the use of their data
Who cannot join
- Any associated neurological pathology or severe or chronic somatic disease (cancer)
- Visual and/or auditory disorders that do not allow for test taking
- Uncontrolled major psychiatric disorders
- Recent treatment with corticosteroids (less than 4 weeks before the evaluation)
- Patients under guardianship, curatorship or safeguard of justice
- Pregnant women
Trial locations and contacts
No sites are listed yet.
About this study
The purpose of this study is to explore inhibition and inference abilities in The Theory of Mind skills in multiple sclerosis patients using the Theory of Mind task.
Read the detailed description
Multiple sclerosis is an autoimmune inflammatory disease of the central nervous system. It can cause lesions responsible for motor, ocular, sensory and cognitive symptoms.
The Theory of Mind and the primary facial emotions recognition (anger, joy, fear, surprise, sadness, disgust) are two processes of social cognition that play a role in the social interactions and social reasoning. The Theory of Mind is defined by the ability to understand the other person including thoughts, beliefs and desires that are unique and that may be different from our own.
In multiple sclerosis, difficulties in social cognition are associated with cognitive disorders, (even if the link with a deficit in executive functions remains debated). Indeed, when attributing a mental state to another person is needed,it is mandatory to put ourselves in the other person's place to adopt another perspective. Thus, several executive functions are required: working memory to maintain and manipulate several perspectives, flexibility to switch from one perspective to another one, and finally the inhibition of our own perspective to adopt the other's point of view.
The Theory of Mind's assessment uses nonverbal false belief task which assesses the ability to inhibit its own perspective to infer the mental state of another and the ability to change its perspective to adopt another's.
Thus, the purpose of this study is to explore inhibition and inference abilities in The Theory of Mind skills in multiple sclerosis patients using the Theory of Mind task.
- Conditions
- Multiple Sclerosis
- Being tested
- Theory of Mind
- Keywords
- Multiple sclerosis, Theory of Mind, Nonverbal false belief task, Cognitive functions, Inhibition and inference abilities
- Medical subject headings
- Multiple Sclerosis, Inhibition, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theory of MindOther
Patients will be submitted to different neuropsychological tests used in routine and the non-verbal false belief task through in the Theory of Mind
| Study group | Role | What they receive |
|---|---|---|
| ¨Patients with multiple sclerosis | Experimental | Patients :
* With multiple sclerosis
* Aged of 18 and over
* Recruited during their consultation in the adult outpatient unit or neurological unit or during a hospitalization. Receives: Other: Theory of Mind |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of correct answers to the "unknown reality" false belief tasks
The number of correct answers to the "unknown reality" false belief tasks out of 12 tests will allow to obtain a mental state inference score
Measured: Day 0
Number of correct answers to the "known reality" false belief tasks
The number of correct answers to the "known reality" false belief tasks out of 12 tests will allow to obtain a score for inhibition of its own perspective
Measured: Day 0
Secondary outcomes (8)
California Verbal Learning Test (CVLT)
Verbal episodic memory abilities will be measured through the 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.
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 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: Day 0
Verbal fluency test
The participant in a given time, evokes (orally or in writing) the greatest number of words according to a given instruction, generally according to a semantic or phonemic categorization. A verbal fluency test measures the participant's ease in producing meaningful speech, both qualitatively and quantitatively
Measured: Day 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: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start1 Jul 2022 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2024 (estimated)
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
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
- NCT04806217
- Sponsor's protocol ID
- RC-P00109
- Acronym
- TDE-SEP
- Status last verified
- Jan 2022
- First submitted
- 16 Mar 2021
- Last updated
- 13 Jan 2022
- 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 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nature of the Link Between Executive Functions and Theory of Mind in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04806217
- Acronym / sponsor ID
- TDE-SEP / RC-P00109
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, Theory of Mind, Nonverbal false belief task, Cognitive functions, Inhibition and inference abilities
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 19 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.
The purpose of this study is to explore inhibition and inference abilities in The Theory of Mind skills in multiple sclerosis patients using the Theory of Mind task.
Detailed description
Multiple sclerosis is an autoimmune inflammatory disease of the central nervous system. It can cause lesions responsible for motor, ocular, sensory and cognitive symptoms.
The Theory of Mind and the primary facial emotions recognition (anger, joy, fear, surprise, sadness, disgust) are two processes of social cognition that play a role in the social interactions and social reasoning. The Theory of Mind is defined by the ability to understand the other person including thoughts, beliefs and desires that are unique and that may be different from our own.
In multiple sclerosis, difficulties in social cognition are associated with cognitive disorders, (even if the link with a deficit in executive functions remains debated). Indeed, when attributing a mental state to another person is needed,it is mandatory to put ourselves in the other person's place to adopt another perspective. Thus, several executive functions are required: working memory to maintain and manipulate several perspectives, flexibility to switch from one perspective to another one, and finally the inhibition of our own perspective to adopt the other's point of view.
The Theory of Mind's assessment uses nonverbal false belief task which assesses the ability to inhibit its own perspective to infer the mental state of another and the ability to change its perspective to adopt another's.
Thus, the purpose of this study is to explore inhibition and inference abilities in The Theory of Mind skills in multiple sclerosis patients using the Theory of Mind task.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ¨Patients with multiple sclerosis | Experimental | Other: Theory of MindPatients : * With multiple sclerosis * Aged of 18 and over * Recruited during their consultation in the adult outpatient unit or neurological unit or during a hospitalization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- With multiple sclerosis
- Age ≥ 18 years old
- Not objecting to the use of their data
Key exclusion criteria (6 listed)
- Any associated neurological pathology or severe or chronic somatic disease (cancer)
- Visual and/or auditory disorders that do not allow for test taking
- Uncontrolled major psychiatric disorders
- Recent treatment with corticosteroids (less than 4 weeks before the evaluation)
- Patients under guardianship, curatorship or safeguard of justice
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 |
|---|---|---|
| Theory of MindPatients will be submitted to different neuropsychological tests used in routine and the non-verbal false belief task through in the Theory of Mind | Other | ¨Patients with multiple sclerosis |
Primary outcome
Number of correct answers to the "unknown reality" false belief tasks
Time frame: Day 0
The number of correct answers to the "unknown reality" false belief tasks out of 12 tests will allow to obtain a mental state inference score
Number of correct answers to the "known reality" false belief tasks
Time frame: Day 0
The number of correct answers to the "known reality" false belief tasks out of 12 tests will allow to obtain a score for inhibition of its own perspective
8 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: Day 0
Verbal fluency test
Time frame: Day 0
Beck Depression Inventory (BDI)
Time frame: Day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
- 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
Questions about this trial
What is this clinical trial studying?
A study testing Theory of Mind in people with Multiple Sclerosis, run by Lille Catholic University.
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 4 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: status not confirmed, as of the sponsor's last update on 13 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amélie Lansiaux, MD, PhD (03.20.22.52.69, lansiaux.amelie@ghicl.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of correct answers to the "unknown reality" false belief tasks (time frame: Day 0). The study lists 2 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 13 Jan 2022.