Emotion Recognition in Benign Epilepsy of Childhood With Centro-Temporal Spikes (BECTS)
BECTS
Facial Emotion Decoding in Benign Partial Epilepsy of Childhood With Centrotemporal Spikes
1 other identifier
observational
200
1 country
1
Brief Summary
The social processes depend on complex cognitive mechanisms, which involve mainly the frontal and temporal lobe regions. Patients with early onset frontal and temporal lobe lesions might later develop important deficits in social integration. Accordingly, children with early onset temporal lobe epilepsy (TLE) demonstrate altered emotion recognition.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2018
1 active site
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
February 22, 2018
CompletedFirst Posted
Study publicly available on registry
March 14, 2018
CompletedStudy Start
First participant enrolled
November 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2020
CompletedNovember 2, 2018
October 1, 2018
1.3 years
February 22, 2018
October 31, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Number (total amount) of errors in facial emotion recognition
A neuropsychologist will sign the number of errors in recognizing each facial emotion expression
an average of 1 year
Rating of the intensity of facial expressions
A neuropsychologist will ask the subjects to rate (on a scale from 0 = not at all to 5 = very much) each stimulus with respect to the prototypical expression of that emotion
an average of 1 year
Rating of the arousal of facial expressions
A neuropsychologist will ask the subjects to evaluate arousal in terms of feeling of high-low energy/wakefulness/alertness by rating each stimulus on a 9-point scale.
an average of 1 year
Rating of the valence of facial expressions
A neuropsychologist will ask the subjects to evaluate valence in terms of feeling of high-low pleasantness-unpleasantness by rating each stimulus on a 9-point scale.
an average of 1 year
Secondary Outcomes (1)
EEG abnormality lateralization and facial emotion recognition
an average of 1 year
Study Arms (2)
Children with BECTS
Children with active BECTS according to state-of-the-art diagnostic criteria of ILAE (International League Against Epilepsy). Eligible subjects will be recruited at their first clinical observation in the epilepsy centers involved in the study. All subjects will perform five diagnostic evaluations named: IDS (Intelligence and Development Scale) MMSPE (Mini Mental State Pediatric Examination) CDI 2 (Children Depression Inventory 2) CBCL (Child Behavior Check List) Tests of facial expression evaluation
Healthy children
Healthy controls matched for sex, age range, and education with no family history for epilepsy or other neuropsychiatric disorders. All subjects will perform the following tests: MMSPE (Mini Mental State Pediatric Examination) CDI 2 (Children Depression Inventory 2) CBCL (Child Behavior Check List) Tests of facial expression evaluation
Interventions
Five pictures (including nonfacial features; i.e., hairs) were used for each emotion, giving a total of 25 trials.Stimuli consist of pictures of facial affect taken from the Ekman and Friesen series.
Eligibility Criteria
Two samples matched for number of partecipants, sex, age range, and education. The two samples will include 200 children with BECTS diagnosis, as many healthy controls.
You may qualify if:
- children diagnosed with active BECTS (e.g. having at least one seizure with epileptiform abnormalities at EEG)
- treated or not with anti-epileptic drugs; age range between 6 and 11
- infants who have not presented an epileptic seizure within 48 hours before the psychodiagnostic evaluation
- patients with a sleep EEG recording; MMSPE (Mini Mental State Pediatric Examination) ≥23.3
You may not qualify if:
- mental retardation
- presence of other neurological or severe neuropsychiatric disorders
- atypical EEG pattern (awake or asleep)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Neuromed IRCCSlead
Study Sites (1)
IRCCS Neuromed
Pozzilli, Isernia, 86077, Italy
Related Publications (2)
De Risi M, Di Gennaro G, Picardi A, Casciato S, Grammaldo LG, D'Aniello A, Lanni D, Meletti S, Modugno N. Facial emotion decoding in patients with Parkinson's disease. Int J Neurosci. 2018 Jan;128(1):71-78. doi: 10.1080/00207454.2017.1366475. Epub 2017 Aug 28.
PMID: 28796560BACKGROUNDMeletti S, Picardi A, De Risi M, Monti G, Esposito V, Grammaldo LG, Di Gennaro G. The affective value of faces in patients achieving long-term seizure freedom after temporal lobectomy. Epilepsy Behav. 2014 Jul;36:97-101. doi: 10.1016/j.yebeh.2014.05.002. Epub 2014 Jun 2.
PMID: 24892756BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Giancarlo Di Gennaro, MD, PhD
IRCCS Neuromed
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor, Neurologist and Psychiatrist of child, Principal investigator
Study Record Dates
First Submitted
February 22, 2018
First Posted
March 14, 2018
Study Start
November 1, 2018
Primary Completion
March 1, 2020
Study Completion
March 1, 2020
Last Updated
November 2, 2018
Record last verified: 2018-10