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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05595005
Other study ID # 2019_12
Secondary ID 2020-A00193-36
Status Not yet recruiting
Phase
First received
Last updated
Start date October 2022
Est. completion date October 2025

Study information

Verified date October 2022
Source University Hospital, Lille
Contact Etienne Allart, MD, PhD
Phone 0320445962
Email etienne.allart@chu-lille.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date October 2025
Est. primary completion date October 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Lille Groupement Interrégional de Recherche Clinique et d'Innovation

Outcome

Type Measure Description Time frame Safety issue
Primary BOLD signal when fear visual recognition Compare correlations of cerebral functional activations (BOLD) by fMRI between groups when stimulus = fear 1 day
Secondary BOLD signal when happiness visual recognition Compare correlations of cerebral functional activations (BOLD) by fMRI between groups when stimulus = happiness 1 day
Secondary Electrical connectivity (EEG) when fear visual recognition Compare cerebral networks activated by a fear visual task recognition in both groups 1 day
Secondary Electrical connectivity (EEG) when fear happiness visual recognition Compare cerebral networks activated by a happiness visual task recognition in both groups 1 day
Secondary Electrical connectivity (EEG) when emotions auditory recognition Compare cerebral networks activated by an auditory task recognition in both groups 1 day
Secondary Relationship between behavioral performance and cerebral networks Correlations between fMRI and EEG networks vs. behavioral performance (emotion recognition) 1 day
Secondary Structural connectivity Disconnectome maps in the stroke patients group 1 day
Secondary Relationship between emotional self-assessment and cerebral networks Correlation between the ESQ (emotional state questionnaire) and cerebral connectivity (EEG) and fMRI networks 1 day
Secondary 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
Secondary 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
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