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

Multiple Sclerosis Clinical Trial

— TDE-SEP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04806217
• Other study ID #: RC-P00109
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: January 1, 2024

Study information

• Verified date: January 2022
• Source: Lille Catholic University
• Contact: Amélie Lansiaux, MD, PhD
• Phone: 03.20.22.52.69
• Email: lansiaux.amelie[@]ghicl.net
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lille Catholic University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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