Neural Bases of Post-stroke Emotion Perception Disorders

Stroke Clinical Trial

— STROKEM  

Official title:

Neural Bases of Post-stroke Emotion Perception Disorders

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
• 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
• 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

Related Conditions & MeSH terms

• Emotions
• Perceptual Disorders
• Stroke
• Stroke Sequelae

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