Clinical trial NCT05595005: Neural Bases of Post-stroke Emotion Perception Disorders
Official title: Neural Bases of Post-stroke Emotion Perception Disorders
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Stroke
Stroke Sequelae
Emotions
Keywords: stroke
emotions
neural bases
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Groupement Interrégional de Recherche Clinique et d'Innovation
First posted: 2022-10-26
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patient group: 40 subjects Healthy control group: 40 subject

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: BOLD signal when fear visual recognition
timeFrame: 1 day
Secondary outcomes:
measure: BOLD signal when happiness visual recognition
timeFrame: 1 day
measure: Electrical connectivity (EEG) when fear visual recognition
timeFrame: 1 day
measure: Electrical connectivity (EEG) when fear happiness visual recognition
timeFrame: 1 day
measure: Electrical connectivity (EEG) when emotions auditory recognition
timeFrame: 1 day
measure: Relationship between behavioral performance and cerebral networks
timeFrame: 1 day
measure: Structural connectivity
timeFrame: 1 day
measure: Relationship between emotional self-assessment and cerebral networks
timeFrame: 1 day
measure: Relationship between the behavioural performance in emotion recognition and executive functions
timeFrame: 1 day
measure: Relationship between lesion characteristics and the behavioral performance in emotion recognition
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Lille
name: Etienne Allart, MD
role: PRINCIPAL_INVESTIGATOR
References: