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

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 Overview

• Status: Not yet recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Theory of Mind

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: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amel Boulafa; Phone Number: 03.20.22.52.69; Email: boulafa.amel@ghicl.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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	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.	Day 0

Collaborators and Investigators

• Sponsor: Lille Catholic University
• Investigators: Principal Investigator: Bruno Lenne, Hopital Saint-Vincent de Paul - Lille

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2022
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): January 1, 2024

Study Registration Dates

• First Submitted: March 16, 2021
• First Submitted That Met QC Criteria: March 17, 2021
• First Posted (Actual): March 19, 2021

Study Record Updates

• Last Update Posted (Actual): January 13, 2022
• Last Update Submitted That Met QC Criteria: January 12, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Multiple sclerosis; Cognitive functions; Theory of Mind; Nonverbal false belief task; Inhibition and inference abilities
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: RC-P00109

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No