Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-25 @ 8:14 PM
Study NCT ID:
NCT05383235
Status:
COMPLETED
Last Update Posted:
2025-07-24
First Post:
2022-04-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Facial Emotion Recognition in Patients Who Committed Sexual Assault Against Children: an EEG Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Apart from investigators in charge of inclusions, outcome assessors will not know to which group the subjects belong.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'PATIENTS:\n\n1. ROUTINE CARE : retrieval of sociodemographic characteristics, medical and psychological assessment, multidisciplinary meeting\n2. RUN-IN PERIOD:\n\n * Eligibility criteria will be assessed during the multidisciplinary meeting\n * Delivery of the information note\n3. STUDY:\n\n * Collection of consent form\n * Facial emotion stimuli presentation task with EEG recording and facial emotion recognition task\n * Neuropsychological evaluation\n * Scales + questionnaires\n * Debriefing\n\nCONTROLS:\n\n1. RUN-IN PERIOD phone call:\n\n * Study presentation\n * Retrieval of sociodemographic characteristics including age and educational level for matching with patients\n * Assessment of eligibility criteria\n * Psychiatric assessment with MINI 5.0 evaluation\n2. STUDY:\n\n * Delivery of the information note\n * Collection of consent form\n * Facial emotion stimuli presentation task with EEG recording and facial emotion recognition task\n * Neuropsychological evaluation\n * Scales + questionnaires\n * Debriefing'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-23', 'studyFirstSubmitDate': '2022-04-20', 'studyFirstSubmitQcDate': '2022-05-16', 'lastUpdatePostDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amplitude of LPP during the facial emotion stimuli presentation task', 'timeFrame': 'one day', 'description': 'The facial emotion stimuli presentation task is based on pictures from the Radbout Faces Database (RaFD). It includes pictures of male and female subjects, adults and children expressing positive, neutral or negative emotion.\n\nDuring the task, cerebral activity will be recorded by EEG to measure amplitude and latency of the LPP (Late Positive Potential).'}], 'secondaryOutcomes': [{'measure': 'Facial emotion recognition abilities', 'timeFrame': 'one day', 'description': 'Subjects and controls will be presented with facial emotion stimuli from the Radbout Faces Database (RaFD). It includes pictures of male and female subjects, adults and children expressing positive, neutral or negative emotion.\n\nWe will measure recognition abilities (% correct response rate, response time, intensity and valence ratings).'}, {'measure': 'TOM-15 (Theory Of Mind 15)', 'timeFrame': 'one day', 'description': 'validated test for assessment of theory of mind'}, {'measure': 'TAS20 (Toronto Alexithymia Scale 20)', 'timeFrame': 'one day', 'description': 'validated scale for assessment of alexithymia Scores vary from 20/100 (low level of alexithymia) to 100/100 (high level of alexithymia)'}, {'measure': 'PCL-R SV (Psychopathy Checklist Revised - Short Version)', 'timeFrame': 'one day', 'description': 'validated checklist for assessment of psychopathy Scores vary from 0/24 (no psychopathic traits) to 24/24 (high level of psychopathic traits)'}, {'measure': 'QCAE (Questionnaire of Cognitive and Affective Empathy)', 'timeFrame': 'one day', 'description': 'validated questionnaire for assessment of cognitive and affective empathy Affective empathy scores vary from 12/48 (low level of affective empathy) to 48/48 (high level of affective empathy).\n\nCognitive empathy scores vary from 19/76 (low level of cognitive empathy) to 76/76 (high level of cognitive empathy).\n\nTotal empathy scores vary from 31/124 (low level of empathy) to 124/124 (high level of empathy).'}, {'measure': 'CECA-Q (Childhood Experiences of Care and Abuse - Questionnaire)', 'timeFrame': 'one day', 'description': 'validated questionnaire for assessment of childhood experience of care and abuse Global parental antipathy scores vary from 20/160 (low level of parental antipathy) to 160/160 (high level of parental antipathy).\n\nNeglect scores vary from 20/160 (low level of neglect) to 160/160 (high level of neglect).\n\nPhysical abuses scores vary from 0/8 (no physical abuses) to 8/8 (high level of physical abuses during childhood) Scores of sexual abuse vary from 0 (no sexual abuse) à 7 (serious sexual abuse) Prevalence of psychological abuse vary from 0/34 (no psychological abuse) to 34/34 (multiple psychological abuses) Frequence of psychological abuse vary from 0/102 ( no psychological abuse) to 102/102 (frequent psychological abuse)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['facial emotion recognition', 'sexual offenders against children', 'LPP'], 'conditions': ['Child Sexual Abuse', 'Emotion Recognition']}, 'descriptionModule': {'briefSummary': 'This study aims to compare the emotional processing in sexual offenders against children versus healthy volunteers using an objective electrophysiological measurement (EEG) during a facial emotion stimuli presentation task. Secondary goal is to assess emotion recognition performances in this population and evaluate the impact of various factors on these performances (type of emotion, age and sex of person expressing the emotion, neuropsychological and cognitive abilities of the subjects).', 'detailedDescription': 'Sexual abuse is a major public health issue. Apart from medical care of victims, it appears essential to intervene with sexual offenders for prevention purposes (from primary prevention to avoid a first sexual abuse to secondary and tertiary prevention to avoid recurrence). In order to improve those prevention strategies, further understanding of offenders neuropsychological and cognitive processes is needed.\n\nFacial emotion recognition capacities, that play a major role in social cognition and generation of appropriate social behavior, has been the subject of few studies in sexual offenders. These studies show heterogeneous results and only one of them specifically targets sexual offenders against children. Furthermore, no study has investigated facial emotion recognition in this population with an objective measurement of emotional processing, such as electroencephalographic (EEG) activity. LPP (late positive potential) amplitude, measured in EEG, is a marker of emotional processing and appears to be modified in particular populations (eg. psychopaths) in response to negative visual stimuli compared to positive stimuli.\n\nThe investigators aim to determine whether LPP amplitude in response to negative facial expressions is modified in sexual offenders against children compared to healthy volunteers and compared to amplitude in response to positive facial expressions.\n\nEffect of facial emotion characteristics (type of emotion, age and sex of person expressing the emotion) on EEG response will be assessed.\n\nVarious neuropsychological and cognitive characteristics (facial emotion recognition, theory of mind, psychopathic traits, childhood trauma, and alexithymia) of patients and controls will also be measured through neuropsychological evaluation and completion of scales and questionnaires, in order to investigate the impact of those factors on facial emotion recognition performances.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria SUBJECTS - Sexual offenders against children:\n\n* Right-handed ;\n* Patient refered to the referral platform for treatment of sexual offenders in Le Vinatier Hospital Center for evaluation of child abuse ;\n* Without any Axis 1 disorder ;\n* Having given informed consent ;\n* Affiliated to French social health care\n\nExclusion Criteria:\n\n* Intellectual disability (identified during routine care in the referral platform for treatment of sexual offenders);\n* Poor understanding of tests and scales instructions ;\n* Neurological or neurodevelopmental history resulting in cognitive impairment with loss of autonomy ;\n* Gardianship or other tutelage measure\n\nHealthy controls :\n\nInclusion Criteria:\n\n* Right-handed ;\n* Without criminal background ;\n* Without any DSM-5 psychiatric disorder (past or present, personal or familial in a first-degree relative) ;\n* Non-caregiver employee of Le Vinatier Hospital Center.\n\nExclusion Criteria:\n\n* Intellectual disability (using fNART if clinical suspicion during run-in period);\n* Poor understanding of tests and scales instructions ;\n* Neurological or neurodevelopmental history resulting in cognitive impairment with loss of autonomy ;\n* Gardianship or other tutelage measure.'}, 'identificationModule': {'nctId': 'NCT05383235', 'acronym': 'EMOREC', 'briefTitle': 'Facial Emotion Recognition in Patients Who Committed Sexual Assault Against Children: an EEG Study', 'organization': {'class': 'OTHER', 'fullName': 'Hôpital le Vinatier'}, 'officialTitle': 'Facial Emotion Recognition in Patients Who Committed Sexual Assault Against Children: an EEG Study', 'orgStudyIdInfo': {'id': '2021-A02763-38'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sexual offenders against children', 'description': 'sexual offenders against children', 'interventionNames': ['Other: ROUTINE CARE', 'Device: Facial emotion stimuli prensentation task with EEG recording and facial emotion recognition task']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy controls', 'description': 'Healthy controls', 'interventionNames': ['Device: Facial emotion stimuli prensentation task with EEG recording and facial emotion recognition task']}], 'interventions': [{'name': 'ROUTINE CARE', 'type': 'OTHER', 'description': '1\\. ROUTINE CARE : retrieval of sociodemographic characteristics, medical and psychological assessment, multidisciplinary meeting about the patient', 'armGroupLabels': ['Sexual offenders against children']}, {'name': 'Facial emotion stimuli prensentation task with EEG recording and facial emotion recognition task', 'type': 'DEVICE', 'otherNames': ['Neuropsychological evaluation'], 'description': '2\\. RUN-IN PERIOD :\n\n* Eligibility criteria will be assessed during the multidisciplinary meeting;\n* Study presentation, delivery of the information note and consent form; 3. STUDY:\n* Collection of consent form;\n* Facial emotion stimuli presentation task with EEG recording and facial emotion recording task;\n* Neuropsychological evaluation (TOM-15);\n* Scales and questionnaires (TAS-20, PCL-R SV, CECAQ, QCAE);\n* Debriefing.', 'armGroupLabels': ['Healthy controls', 'Sexual offenders against children']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69678', 'city': 'Bron', 'state': 'Auvergne-Rhône-Alpes', 'country': 'France', 'facility': 'Centre Hospitalier Le Vinatier', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}], 'overallOfficials': [{'name': 'Sabine MOUCHET, PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CH le Vinatier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hôpital le Vinatier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}