Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2025-12-31 @ 2:02 PM
Study NCT ID:
NCT05595005
Status:
RECRUITING
Last Update Posted:
2025-08-24
First Post:
2022-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neural Bases of Post-stroke Emotion Perception Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-19', 'studyFirstSubmitDate': '2022-10-18', 'studyFirstSubmitQcDate': '2022-10-21', 'lastUpdatePostDateStruct': {'date': '2025-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BOLD signal when fear visual recognition', 'timeFrame': '1 day', 'description': 'Compare correlations of cerebral functional activations (BOLD) by fMRI between groups when stimulus = fear'}], 'secondaryOutcomes': [{'measure': 'BOLD signal when happiness visual recognition', 'timeFrame': '1 day', 'description': 'Compare correlations of cerebral functional activations (BOLD) by fMRI between groups when stimulus = happiness'}, {'measure': 'Electrical connectivity (EEG) when fear visual recognition', 'timeFrame': '1 day', 'description': 'Compare cerebral networks activated by a fear visual task recognition in both groups'}, {'measure': 'Electrical connectivity (EEG) when fear happiness visual recognition', 'timeFrame': '1 day', 'description': 'Compare cerebral networks activated by a happiness visual task recognition in both groups'}, {'measure': 'Electrical connectivity (EEG) when emotions auditory recognition', 'timeFrame': '1 day', 'description': 'Compare cerebral networks activated by an auditory task recognition in both groups'}, {'measure': 'Relationship between behavioral performance and cerebral networks', 'timeFrame': '1 day', 'description': 'Correlations between fMRI and EEG networks vs. behavioral performance (emotion recognition)'}, {'measure': 'Structural connectivity', 'timeFrame': '1 day', 'description': 'Disconnectome maps in the stroke patients group'}, {'measure': 'Relationship between emotional self-assessment and cerebral networks', 'timeFrame': '1 day', 'description': 'Correlation between the ESQ (emotional state questionnaire) and cerebral connectivity (EEG) and fMRI networks'}, {'measure': 'Relationship between the behavioural performance in emotion recognition and executive functions', 'timeFrame': '1 day', 'description': 'Correlation between behavioral performance in emotion recognition (Eckman Test) and executive functions (Stroop Test) in the stroke group'}, {'measure': 'Relationship between lesion characteristics and the behavioral performance in emotion recognition', 'timeFrame': '1 day', 'description': 'Correlation between lesion volume and the behavioural performance in emotion recognition (Eckman Test)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stroke', 'emotions', 'neural bases'], 'conditions': ['Stroke', 'Stroke Sequelae', 'Emotions']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patient group: 40 subjects Healthy control group: 40 subject', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nStroke group:\n\n* Man or Woman\n* Age 18-80y\n* Unique stroke, ischemic or hemorrhagic\n* at the chronic phase (\\< 6 months)\n* Written informed consent\n* subject having a social insurance\n* Subject who consent to complete all the study's experiments\n\nHealthy controls group:\n\n* Man or Woman\n* Age 18-80y\n* No history of neurological or psychiatric disease.\n\nExclusion Criteria:\n\nStroke group\n\n* Subject who is unable to consent (due to dementia, severe aphasia, psychiatric disorder...)\n* History of other neurologic disorders\n* Significant le vel of depression or anxiety, assessed by the STAI and the BDI questionnaires\n* Non corrected visual loss\n* Subjects suffering from visual neglect (assessed by the Bells Test and a bisection test (20mm)\n* contra-indications to MRI\n* pregnant or breastfeeding woman\n* Women of childbearing age without effective contraception\n\nHealthy controls group\n\n* Subject who is unable to consent (due to dementia, severe aphasia, psychiatric disorder...)\n* History of neurologic disorders\n* Significant level of depression or anxiety, assessed by the STAI and the BDI questionnaires\n* Non-corrected visual loss\n* contra-indications to MRI\n* pregnant or breastfeeding woman\n* Women of childbearing age without effective contraception"}, 'identificationModule': {'nctId': 'NCT05595005', 'acronym': 'STROKEM', 'briefTitle': 'Neural Bases of Post-stroke Emotion Perception Disorders', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Neural Bases of Post-stroke Emotion Perception Disorders', 'orgStudyIdInfo': {'id': '2019_12'}, 'secondaryIdInfos': [{'id': '2020-A00193-36', 'type': 'OTHER', 'domain': 'ID-RCB number, ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Stroke', 'description': 'Stroke patients (ischemic or hemorrhagic) in the chronic phase (\\> 6 months)'}, {'label': 'Healthy controls', 'description': 'Healthy adult controls'}]}, 'contactsLocationsModule': {'locations': [{'zip': '59037', 'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Etienne Allart', 'role': 'CONTACT'}], 'facility': 'Hôpital Swynghedauw', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'centralContacts': [{'name': 'Etienne Allart, MD, PhD', 'role': 'CONTACT', 'email': 'etienne.allart@chu-lille.fr', 'phone': '0320445962', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Etienne Allart, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'collaborators': [{'name': "Groupement Interrégional de Recherche Clinique et d'Innovation", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}