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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05383235
Other study ID # 2021-A02763-38
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 20, 2022
Est. completion date May 20, 2026

Study information

Verified date April 2022
Source Hôpital le Vinatier
Contact Sabine MOUCHET, PH
Phone 0437915309
Email sabine.mouchet@ch-le-vinatier.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Description:

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. Facial 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. The 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. Effect of facial emotion characteristics (type of emotion, age and sex of person expressing the emotion) on EEG response will be assessed. Various 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 56
Est. completion date May 20, 2026
Est. primary completion date May 20, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 25 Years to 55 Years
Eligibility Inclusion Criteria SUBJECTS - Sexual offenders against children: - Right-handed ; - Patient refered to the referral platform for treatment of sexual offenders in Le Vinatier Hospital Center for evaluation of child abuse ; - Without any Axis 1 disorder ; - Having given informed consent ; - Affiliated to French social health care Exclusion Criteria: - Intellectual disability (identified during routine care in the referral platform for treatment of sexual offenders); - Poor understanding of tests and scales instructions ; - Neurological or neurodevelopmental history resulting in cognitive impairment with loss of autonomy ; - Gardianship or other tutelage measure Healthy controls : Inclusion Criteria: - Right-handed ; - Without criminal background ; - Without any DSM-5 psychiatric disorder (past or present, personal or familial in a first-degree relative) ; - Non-caregiver employee of Le Vinatier Hospital Center. Exclusion Criteria: - Intellectual disability (using fNART if clinical suspicion during run-in period); - Poor understanding of tests and scales instructions ; - Neurological or neurodevelopmental history resulting in cognitive impairment with loss of autonomy ; - Gardianship or other tutelage measure.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
ROUTINE CARE
1. ROUTINE CARE : retrieval of sociodemographic characteristics, medical and psychological assessment, multidisciplinary meeting about the patient
Device:
Facial emotion stimuli prensentation task with EEG recording and facial emotion recognition task
2. RUN-IN PERIOD : Eligibility criteria will be assessed during the multidisciplinary meeting; Study presentation, delivery of the information note and consent form; 3. STUDY: Collection of consent form; Facial emotion stimuli presentation task with EEG recording and facial emotion recording task; Neuropsychological evaluation (TOM-15); Scales and questionnaires (TAS-20, PCL-R SV, CECAQ, QCAE); Debriefing.

Locations

Country Name City State
France Centre Hospitalier Le Vinatier Bron Rhône Alpes

Sponsors (1)

Lead Sponsor Collaborator
Hôpital le Vinatier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Amplitude of LPP during the facial emotion stimuli presentation task 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.
During the task, cerebral activity will be recorded by EEG to measure amplitude and latency of the LPP (Late Positive Potential).
one day
Secondary Facial emotion recognition abilities 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.
We will measure recognition abilities (% correct response rate, response time, intensity and valence ratings).
one day
Secondary TOM-15 (Theory Of Mind 15) validated test for assessment of theory of mind one day
Secondary TAS20 (Toronto Alexithymia Scale 20) validated scale for assessment of alexithymia Scores vary from 20/100 (low level of alexithymia) to 100/100 (high level of alexithymia) one day
Secondary PCL-R SV (Psychopathy Checklist Revised - Short Version) validated checklist for assessment of psychopathy Scores vary from 0/24 (no psychopathic traits) to 24/24 (high level of psychopathic traits) one day
Secondary QCAE (Questionnaire of Cognitive and Affective Empathy) 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).
Cognitive empathy scores vary from 19/76 (low level of cognitive empathy) to 76/76 (high level of cognitive empathy).
Total empathy scores vary from 31/124 (low level of empathy) to 124/124 (high level of empathy).
one day
Secondary CECA-Q (Childhood Experiences of Care and Abuse - Questionnaire) 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).
Neglect scores vary from 20/160 (low level of neglect) to 160/160 (high level of neglect).
Physical 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)
one day
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