NCT05383235

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 20, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

July 12, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2025

Completed
Last Updated

July 24, 2025

Status Verified

July 1, 2025

Enrollment Period

2.8 years

First QC Date

April 20, 2022

Last Update Submit

July 23, 2025

Conditions

Keywords

facial emotion recognitionsexual offenders against childrenLPP

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Facial emotion recognition abilities

    one day

  • TOM-15 (Theory Of Mind 15)

    one day

  • TAS20 (Toronto Alexithymia Scale 20)

    one day

  • PCL-R SV (Psychopathy Checklist Revised - Short Version)

    one day

  • QCAE (Questionnaire of Cognitive and Affective Empathy)

    one day

  • +1 more secondary outcomes

Study Arms (2)

Sexual offenders against children

EXPERIMENTAL

sexual offenders against children

Other: ROUTINE CAREDevice: Facial emotion stimuli prensentation task with EEG recording and facial emotion recognition task

Healthy controls

ACTIVE COMPARATOR

Healthy controls

Device: Facial emotion stimuli prensentation task with EEG recording and facial emotion recognition task

Interventions

1\. ROUTINE CARE : retrieval of sociodemographic characteristics, medical and psychological assessment, multidisciplinary meeting about the patient

Sexual offenders against children

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.

Also known as: Neuropsychological evaluation
Healthy controlsSexual offenders against children

Eligibility Criteria

Age25 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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 :
  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Le Vinatier

Bron, Auvergne-Rhône-Alpes, 69678, France

Location

Study Officials

  • Sabine MOUCHET, PH

    CH le Vinatier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Apart from investigators in charge of inclusions, outcome assessors will not know to which group the subjects belong.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2022

First Posted

May 20, 2022

Study Start

July 12, 2022

Primary Completion

May 15, 2025

Study Completion

May 15, 2025

Last Updated

July 24, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations