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History of Changes for Study: NCT04806217
Nature of the Link Between Executive Functions and Theory of Mind in Multiple Sclerosis (TDE-SEP)
Latest version (submitted January 12, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 17, 2021 None (earliest Version on record)
2 January 12, 2022 Study Status
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Study NCT04806217
Submitted Date:  March 17, 2021 (v1)

Open or close this module Study Identification
Unique Protocol ID: RC-P00109
Brief Title: Nature of the Link Between Executive Functions and Theory of Mind in Multiple Sclerosis (TDE-SEP)
Official Title: Nature of the Link Between Executive Functions and Theory of Mind in Multiple Sclerosis
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2021
Overall Status: Not yet recruiting
Study Start: July 1, 2021
Primary Completion: January 1, 2023 [Anticipated]
Study Completion: January 1, 2023 [Anticipated]
First Submitted: March 16, 2021
First Submitted that
Met QC Criteria:
March 17, 2021
First Posted: March 19, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:
March 17, 2021
Last Update Posted: March 19, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Lille Catholic University
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module 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.

Open or close this module Conditions
Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis
Theory of Mind
Nonverbal false belief task
Cognitive functions
Inhibition and inference abilities
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Diagnostic
Study Phase: Not Applicable
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 40 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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.
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
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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
2. 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
Secondary Outcome Measures:
1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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
8. 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.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Central Contact Person: Amélie Lansiaux, MD, PhD
Telephone: 03.20.22.52.69
Email: lansiaux.amelie@ghicl.net
Central Contact Backup: Amel Boulafa
Telephone: 03.20.22.52.69
Email: boulafa.amel@ghicl.net
Study Officials: Bruno Lenne
Principal Investigator
Hôpital Saint-Vincent de Paul - Lille
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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