Neural Bases of Post-stroke Emotion Perception Disorders (STROKEM)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke; Stroke Sequelae; Emotions

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 Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: Etienne Allart, MD, PhD; Phone Number: +33 0320445962; Email: etienne.allart@chu-lille.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patient group: 40 subjects Healthy control group: 40 subject

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Stroke; Stroke patients (ischemic or hemorrhagic) in the chronic phase (> 6 months)
Healthy controls; Healthy adult controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BOLD signal when fear visual recognition	Compare correlations of cerebral functional activations (BOLD) by fMRI between groups when stimulus = fear	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BOLD signal when happiness visual recognition	Compare correlations of cerebral functional activations (BOLD) by fMRI between groups when stimulus = happiness	1 day
Electrical connectivity (EEG) when fear visual recognition	Compare cerebral networks activated by a fear visual task recognition in both groups	1 day
Electrical connectivity (EEG) when fear happiness visual recognition	Compare cerebral networks activated by a happiness visual task recognition in both groups	1 day
Electrical connectivity (EEG) when emotions auditory recognition	Compare cerebral networks activated by an auditory task recognition in both groups	1 day
Relationship between behavioral performance and cerebral networks	Correlations between fMRI and EEG networks vs. behavioral performance (emotion recognition)	1 day
Structural connectivity	Disconnectome maps in the stroke patients group	1 day
Relationship between emotional self-assessment and cerebral networks	Correlation between the ESQ (emotional state questionnaire) and cerebral connectivity (EEG) and fMRI networks	1 day
Relationship between the behavioural performance in emotion recognition and executive functions	Correlation between behavioral performance in emotion recognition (Eckman Test) and executive functions (Stroop Test) in the stroke group	1 day
Relationship between lesion characteristics and the behavioral performance in emotion recognition	Correlation between lesion volume and the behavioural performance in emotion recognition (Eckman Test)	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Collaborators: Groupement Interrégional de Recherche Clinique et d'Innovation

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2022
• Primary Completion (Anticipated): October 1, 2025
• Study Completion (Anticipated): October 1, 2025

Study Registration Dates

• First Submitted: October 18, 2022
• First Submitted That Met QC Criteria: October 21, 2022
• First Posted (Actual): October 26, 2022

Study Record Updates

• Last Update Posted (Actual): October 26, 2022
• Last Update Submitted That Met QC Criteria: October 21, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: stroke; emotions; neural bases
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Stroke; Perceptual Disorders
• Other Study ID Numbers: 2019_12; 2020-A00193-36 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No