NCT04806217

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
Completed

Started Jul 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 19, 2021

Completed
1.3 years until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

January 13, 2022

Status Verified

January 1, 2022

Enrollment Period

1.5 years

First QC Date

March 16, 2021

Last Update Submit

January 12, 2022

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosisTheory of MindNonverbal false belief taskCognitive functionsInhibition and inference abilities

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (8)

  • California Verbal Learning Test (CVLT)

    Day 0

  • Brief Visuo-spatial Memory Test (BVMT)

    Day 0

  • Symbol Digit Modalities Test (SDMT)

    Day 0

  • Stroop test

    Day 0

  • Trail Making test

    Day 0

  • +3 more secondary outcomes

Study Arms (1)

¨Patients with multiple sclerosis

EXPERIMENTAL

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

Interventions

Theory of MindOTHER

Patients will be submitted to different neuropsychological tests used in routine and the non-verbal false belief task through in the Theory of Mind

¨Patients with multiple sclerosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • People :
  • With multiple sclerosis
  • Age ≥ 18 years old
  • Not objecting to the use of their data

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Multiple SclerosisInhibition, Psychological

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesBehavior

Study Officials

  • Bruno Lenne

    Hôpital Saint Vincent de Paul, Lille

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amélie Lansiaux, MD, PhD

CONTACT

03.20.22.52.69lansiaux.amelie@ghicl.net

Amel Boulafa

CONTACT

03.20.22.52.69boulafa.amel@ghicl.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2021

First Posted

March 19, 2021

Study Start

July 1, 2022

Primary Completion

January 1, 2024

Study Completion

January 1, 2024

Last Updated

January 13, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share