Child Sexual AbuseEMORECNCT05383235
Facial Emotion Recognition in Patients Who Committed Sexual Assault Against Children: an EEG Study
A study testing ROUTINE CARE and Facial emotion stimuli prensentation task with EEG recording and facial emotion recognition task in people with Child Sexual Abuse and Emotion Recognition, run by Hôpital le Vinatier at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 25 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Child Sexual Abuse, Emotion Recognition
- What is being tested?
- ROUTINE CARE and Facial emotion stimuli prensentation task with EEG recording and facial emotion recognition task
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jul 2022to 15 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 :
- Intellectual disability (using fNART if clinical suspicion during run-in period);
Show all 9Show fewer
- Poor understanding of tests and scales instructions ;
- Neurological or neurodevelopmental history resulting in cognitive impairment with loss of autonomy ;
- Gardianship or other tutelage measure.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the detailed 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.
- Conditions
- Child Sexual Abuse, Emotion Recognition
- Being tested
- ROUTINE CARE, Facial emotion stimuli prensentation task with EEG recording and facial emotion recognition task
- Keywords
- facial emotion recognition, sexual offenders against children, LPP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROUTINE CAREOther
- ROUTINE CARE : retrieval of sociodemographic characteristics, medical and psychological assessment, multidisciplinary meeting about the patient
Facial emotion stimuli prensentation task with EEG recording and facial emotion recognition taskDevice
Also called Neuropsychological evaluation
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Sexual offenders against children | Experimental | sexual offenders against children Receives: Other: ROUTINE CARE; Device: Facial emotion stimuli prensentation task with EEG recording and facial emotion recognition task |
| Healthy controls | Active comparator | Healthy controls Receives: Device: Facial emotion stimuli prensentation task with EEG recording and facial emotion recognition task |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: one day
Secondary outcomes (6)
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).
Measured: one day
TOM-15 (Theory Of Mind 15)
validated test for assessment of theory of mind
Measured: one day
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)
Measured: one day
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)
Measured: one day
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).
Measured: one day
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)
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start12 Jul 2022
- Primary completion15 May 2025
- Study completion15 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child Sexual AbuseStudies of the same condition, open and under way.
- More trials run by Hôpital le VinatierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- PATIENTS: 1. ROUTINE CARE : retrieval of sociodemographic characteristics, medical and psychological assessment, multidisciplinary meeting 2. RUN-IN PERIOD: * Eligibility criteria will be assessed during the multidisciplinary meeting * Delivery of the information note 3. STUDY: * Collection of consent form * Facial emotion stimuli presentation task with EEG recording and facial emotion recognition task * Neuropsychological evaluation * Scales + questionnaires * Debriefing CONTROLS: 1. RUN-IN PERIOD phone call: * Study presentation * Retrieval of sociodemographic characteristics including age and educational level for matching with patients * Assessment of eligibility criteria * Psychiatric assessment with MINI 5.0 evaluation 2. STUDY: * Delivery of the information note * Collection of consent form * Facial emotion stimuli presentation task with EEG recording and facial emotion recognition task * Neuropsychological evaluation * Scales + questionnaires * Debriefing
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sabine MOUCHET, PH, Principal investigator, CH le Vinatier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05383235
- Sponsor's protocol ID
- 2021-A02763-38
- Acronym
- EMOREC
- Status last verified
- Jul 2025
- First submitted
- 20 Apr 2022
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facial Emotion Recognition in Patients Who Committed Sexual Assault Against Children: an EEG Study
- ClinicalTrials.gov ID
- NCT05383235
- Acronym / sponsor ID
- EMOREC / 2021-A02763-38
- Conditions
- Child Sexual Abuse, Emotion Recognition
- Keywords
- facial emotion recognition, sexual offenders against children, LPP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Study start
- 12 Jul 2022 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 20 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- PATIENTS: 1. ROUTINE CARE : retrieval of sociodemographic characteristics, medical and psychological assessment, multidisciplinary meeting 2. RUN-IN PERIOD: * Eligibility criteria will be assessed during the multidisciplinary meeting * Delivery of the information note 3. STUDY: * Collection of consent form * Facial emotion stimuli presentation task with EEG recording and facial emotion recognition task * Neuropsychological evaluation * Scales + questionnaires * Debriefing CONTROLS: 1. RUN-IN PERIOD phone call: * Study presentation * Retrieval of sociodemographic characteristics including age and educational level for matching with patients * Assessment of eligibility criteria * Psychiatric assessment with MINI 5.0 evaluation 2. STUDY: * Delivery of the information note * Collection of consent form * Facial emotion stimuli presentation task with EEG recording and facial emotion recognition task * Neuropsychological evaluation * Scales + questionnaires * Debriefing
| Arm | Type | Receives |
|---|---|---|
| Sexual offenders against children | Experimental | Other: ROUTINE CARE, Device: Facial emotion stimuli prensentation task with EEG recording and facial emotion recognition tasksexual offenders against children |
| Healthy controls | Active comparator | Device: Facial emotion stimuli prensentation task with EEG recording and facial emotion recognition taskHealthy controls |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
- Intellectual disability (using fNART if clinical suspicion during run-in period);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ROUTINE CARE1. ROUTINE CARE : retrieval of sociodemographic characteristics, medical and psychological assessment, multidisciplinary meeting about the patient | Other | Sexual offenders against children |
| Facial emotion stimuli prensentation task with EEG recording and facial emotion recognition taskAlso: Neuropsychological evaluation2. 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. | Device | Healthy controls, Sexual offenders against children |
Primary outcome
Amplitude of LPP during the facial emotion stimuli presentation task
Time frame: one day
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).
6 secondary outcomes
Facial emotion recognition abilities
Time frame: one day
TOM-15 (Theory Of Mind 15)
Time frame: one day
TAS20 (Toronto Alexithymia Scale 20)
Time frame: one day
PCL-R SV (Psychopathy Checklist Revised - Short Version)
Time frame: one day
QCAE (Questionnaire of Cognitive and Affective Empathy)
Time frame: one day
CECA-Q (Childhood Experiences of Care and Abuse - Questionnaire)
Time frame: one day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Individual participant dataSharing planned: No
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Partner
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabine MOUCHET, PH principal investigator
CH le Vinatier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ROUTINE CARE and Facial emotion stimuli prensentation task with EEG recording and facial emotion recognition task in people with Child Sexual Abuse and Emotion Recognition, run by Hôpital le Vinatier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amplitude of LPP during the facial emotion stimuli presentation task (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.