Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Other: Theory of Mind Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Nature of the Link Between Executive Functions and Theory of Mind in Multiple Sclerosis
Estimated Study Start Date : July 1, 2022
Estimated Primary Completion Date : January 1, 2024
Estimated Study Completion Date : January 1, 2024

Resource links provided by the National Library of Medicine


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




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04806217


Contacts
Layout table for location contacts
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

Sponsors and Collaborators
Lille Catholic University
Investigators
Layout table for investigator information
Principal Investigator: Bruno Lenne Hôpital Saint-Vincent de Paul - Lille
Layout table for additonal information
Responsible Party: Lille Catholic University
ClinicalTrials.gov Identifier: NCT04806217    
Other Study ID Numbers: RC-P00109
First Posted: March 19, 2021    Key Record Dates
Last Update Posted: January 13, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lille Catholic University:
Multiple sclerosis
Theory of Mind
Nonverbal false belief task
Cognitive functions
Inhibition and inference abilities
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases