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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
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, Theory of Mind, Nonverbal false belief task, Cognitive functions, Inhibition and inference abilities

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    March 16, 2021
    Last Updated
    January 12, 2022
    Sponsor
    Lille Catholic University
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    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

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    Nature of the Link Between Executive Functions and Theory of Mind in Multiple Sclerosis

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