Nature of the Link Between Executive Functions and Theory of Mind in Multiple Sclerosis (TDE-SEP)
Primary Purpose
Multiple Sclerosis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Theory of Mind
Sponsored by

About this trial
This is an interventional diagnostic trial for Multiple Sclerosis focused on measuring Multiple sclerosis, Theory of Mind, Nonverbal false belief task, Cognitive functions, Inhibition and inference abilities
Eligibility Criteria
Inclusion Criteria:
People :
- With multiple sclerosis
- Age ≥ 18 years old
- Not objecting to the use of their data
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
¨Patients with multiple sclerosis
Arm Description
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.
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
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.
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.
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.
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
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.
Full Information
NCT ID
NCT04806217
First Posted
March 16, 2021
Last Updated
January 12, 2022
Sponsor
Lille Catholic University
1. Study Identification
Unique Protocol Identification Number
NCT04806217
Brief Title
Nature of the Link Between Executive Functions and Theory of Mind in Multiple Sclerosis
Acronym
TDE-SEP
Official Title
Nature of the Link Between Executive Functions and Theory of Mind in Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2022 (Anticipated)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple sclerosis, Theory of Mind, Nonverbal false belief task, Cognitive functions, Inhibition and inference abilities
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
¨Patients with multiple sclerosis
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Theory of Mind
Intervention Description
Patients will be submitted to different neuropsychological tests used in routine and the non-verbal false belief task through in the Theory of Mind
Primary Outcome Measure Information:
Title
Number of correct answers to the "unknown reality" false belief tasks
Description
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
Time Frame
Day 0
Title
Number of correct answers to the "known reality" false belief tasks
Description
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
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
California Verbal Learning Test (CVLT)
Description
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.
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 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
Day 0
Title
Verbal fluency test
Description
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
Time Frame
Day 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
Day 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
People :
With multiple sclerosis
Age ≥ 18 years old
Not objecting to the use of their data
Exclusion Criteria:
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
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
Amel Boulafa
Phone
03.20.22.52.69
Email
boulafa.amel@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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Nature of the Link Between Executive Functions and Theory of Mind in Multiple Sclerosis
We'll reach out to this number within 24 hrs