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Nature of the Link Between Executive Functions and Theory of Mind in Multiple Sclerosis (TDE-SEP)

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ClinicalTrials.gov Identifier: NCT04806217
Recruitment Status : Not yet recruiting
First Posted : March 19, 2021
Last Update Posted : January 13, 2022
Sponsor:
Information provided by (Responsible Party):
Lille Catholic University

Tracking Information
First Submitted Date  ICMJE March 16, 2021
First Posted Date  ICMJE March 19, 2021
Last Update Posted Date January 13, 2022
Estimated Study Start Date  ICMJE July 1, 2022
Estimated Primary Completion Date January 1, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 17, 2021)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 17, 2021)
  • California Verbal Learning Test (CVLT) [ Time Frame: Day 0 ]
    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) [ Time Frame: Day 0 ]
    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) [ Time Frame: Day 0 ]
    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 [ Time Frame: Day 0 ]
    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 [ Time Frame: Day 0 ]
    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 [ Time Frame: Day 0 ]
    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 [ Time Frame: Day 0 ]
    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) [ Time Frame: Day 0 ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nature of the Link Between Executive Functions and Theory of Mind in Multiple Sclerosis
Official Title  ICMJE Nature of the Link Between Executive Functions and Theory of Mind in Multiple Sclerosis
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE Other: Theory of Mind
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 Arms  ICMJE Experimental: ¨Patients with multiple sclerosis

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: Other: Theory of Mind
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 17, 2021)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2024
Estimated Primary Completion Date January 1, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Amélie Lansiaux, MD, PhD 03.20.22.52.69 lansiaux.amelie@ghicl.net
Contact: Amel Boulafa 03.20.22.52.69 boulafa.amel@ghicl.net
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04806217
Other Study ID Numbers  ICMJE RC-P00109
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Lille Catholic University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Lille Catholic University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Bruno Lenne Hôpital Saint-Vincent de Paul - Lille
PRS Account Lille Catholic University
Verification Date January 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP