Clinical trial NCT03465566: Emotion Recognition in Benign Epilepsy of Childhood With Centro-Temporal Spikes (BECTS)
Official title: Facial Emotion Decoding in Benign Partial Epilepsy of Childhood With Centrotemporal Spikes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: BECTS
Epilepsy, Rolandic
Keywords: Emotion
Social cognition
Childhood epilepsy
Lead sponsor: Neuromed IRCCS
Sponsor class: OTHER
First posted: 2018-03-14
Enrollment: 200
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Detailed description: Study design: Multicentre, Case-control study.

Emotion recognition is a first step for the development of the capacity to judge the thoughts, intentions, and desires of others. In infants, the capacity to identify, distinguish, and interpret emotions is limited, but these processes are developing rapidly and innately during the first years of life, on the same neural bases as those described in adulthood. Children with BECTS show altered social behavior. In fact, deficit in social cognition could derive from brain dysfunction in the frontotemporal regions primarily affected in BECTS, since these regions are also viewed as playing an important role in social cognition and development of social skills.

The investigators hypothesized that children with BECTS might have altered social cognitive skills and underlying neural networks.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* mental retardation
* presence of other neurological or severe neuropsychiatric disorders
* atypical EEG pattern (awake or asleep)

Primary outcomes:
measure: Number (total amount) of errors in facial emotion recognition
timeFrame: an average of 1 year
measure: Rating of the intensity of facial expressions
timeFrame: an average of 1 year
measure: Rating of the arousal of facial expressions
timeFrame: an average of 1 year
measure: Rating of the valence of facial expressions
timeFrame: an average of 1 year
Secondary outcomes:
measure: EEG abnormality lateralization and facial emotion recognition
timeFrame: an average of 1 year
Other outcomes:
Locations:
city: Pozzilli
country: Italy
facility: IRCCS Neuromed
state: Isernia
Study officials:
affiliation: IRCCS Neuromed
name: Giancarlo Di Gennaro, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Meletti 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.