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STROKEM: Neural Bases of Post-stroke Emotion Perception Disorders

Sponsor
University Hospital, Lille (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05595005
Collaborator
Groupement Interrégional de Recherche Clinique et d'Innovation (Other)
80
Enrollment
36
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This monocentric physiological study will evaluate the neural bases of visual recognition of emotions in stroke patients vs. healthy controls using MRI (functional and structural connectivity) and EEG.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This monocentric physiological study will evaluate the neural bases of visual recognition of emotions in stroke patients vs healthy controls (2 groups of 40 subjects). It will include functional MRI, structural MRI (disconnectome), EEG, and behavioral assessments of emotion recognition and executive functions.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    80 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Neural Bases of Post-stroke Emotion Perception Disorders
    Anticipated Study Start Date :
    Oct 1, 2022
    Anticipated Primary Completion Date :
    Oct 1, 2025
    Anticipated Study Completion Date :
    Oct 1, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    Stroke

    Stroke patients (ischemic or hemorrhagic) in the chronic phase (> 6 months)
    Healthy controls

    Healthy adult controls

    Outcome Measures

    Primary Outcome Measures

    1. BOLD signal when fear visual recognition [1 day]

      Compare correlations of cerebral functional activations (BOLD) by fMRI between groups when stimulus = fear

    Secondary Outcome Measures

    1. BOLD signal when happiness visual recognition [1 day]

      Compare correlations of cerebral functional activations (BOLD) by fMRI between groups when stimulus = happiness

    2. Electrical connectivity (EEG) when fear visual recognition [1 day]

      Compare cerebral networks activated by a fear visual task recognition in both groups

    3. Electrical connectivity (EEG) when fear happiness visual recognition [1 day]

      Compare cerebral networks activated by a happiness visual task recognition in both groups

    4. Electrical connectivity (EEG) when emotions auditory recognition [1 day]

      Compare cerebral networks activated by an auditory task recognition in both groups

    5. Relationship between behavioral performance and cerebral networks [1 day]

      Correlations between fMRI and EEG networks vs. behavioral performance (emotion recognition)

    6. Structural connectivity [1 day]

      Disconnectome maps in the stroke patients group

    7. Relationship between emotional self-assessment and cerebral networks [1 day]

      Correlation between the ESQ (emotional state questionnaire) and cerebral connectivity (EEG) and fMRI networks

    8. Relationship between the behavioural performance in emotion recognition and executive functions [1 day]

      Correlation between behavioral performance in emotion recognition (Eckman Test) and executive functions (Stroop Test) in the stroke group

    9. Relationship between lesion characteristics and the behavioral performance in emotion recognition [1 day]

      Correlation between lesion volume and the behavioural performance in emotion recognition (Eckman Test)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    Stroke group:

    • Man or Woman

    • Age 18-80y

    • Unique stroke, ischemic or hemorrhagic

    • at the chronic phase (< 6 months)

    • Written informed consent

    • subject having a social insurance

    • Subject who consent to complete all the study's experiments

    Healthy controls group:

    • Man or Woman

    • Age 18-80y

    • No history of neurological or psychiatric disease.

    Exclusion Criteria:

    Stroke group

    • Subject who is unable to consent (due to dementia, severe aphasia, psychiatric disorder...)

    • History of other neurologic disorders

    • Significant le vel of depression or anxiety, assessed by the STAI and the BDI questionnaires

    • Non corrected visual loss

    • Subjects suffering from visual neglect (assessed by the Bells Test and a bisection test (20mm)

    • contra-indications to MRI

    • pregnant or breastfeeding woman

    • Women of childbearing age without effective contraception

    Healthy controls group

    • Subject who is unable to consent (due to dementia, severe aphasia, psychiatric disorder...)

    • History of neurologic disorders

    • Significant level of depression or anxiety, assessed by the STAI and the BDI questionnaires

    • Non-corrected visual loss

    • contra-indications to MRI

    • pregnant or breastfeeding woman

    • Women of childbearing age without effective contraception

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University Hospital, Lille
    • Groupement InterrĂ©gional de Recherche Clinique et d'Innovation

    Investigators

    • Principal Investigator: Etienne Allart, MD, University Hospital, Lille

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Lille
    ClinicalTrials.gov Identifier:
    NCT05595005
    Other Study ID Numbers:
    • 2019_12
    • 2020-A00193-36
    First Posted:
    Oct 26, 2022
    Last Update Posted:
    Oct 26, 2022
    Last Verified:
    Oct 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Lille
    stroke
    emotions
    neural bases
    Additional relevant MeSH terms:
    Stroke
    Perceptual Disorders

    Study Results

    No Results Posted as of Oct 26, 2022