Emotion Recognition in Benign Epilepsy of Childhood With Centro-Temporal Spikes (BECTS)

• Conditions: BECTS; Epilepsy, Rolandic
• Interventions: Diagnostic Test: IDS;MMSPE;CDI 2;CBCL;tests of facial expression evaluation

• Registration Number: NCT03465566
• Lead Sponsor: Neuromed IRCCS

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.

Study Timeline

• Study First Submitted: 2018-02-22
• Study First Submitted QC: 2018-03-13
• Study First Posted: 2018-03-14
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-31
• Study Start: 2018-11-01
• Last Update Posted: 2018-11-02
• Primary Completion: 2020-03-01
• Study Completion: 2020-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy children	IDS;MMSPE;CDI 2;CBCL;tests of facial expression evaluation	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
Children with BECTS	IDS;MMSPE;CDI 2;CBCL;tests of facial expression evaluation	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

Primary Outcome Measures

Name	Time	Method
Rating of the arousal of facial expressions	an average of 1 year	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.
Number (total amount) of errors in facial emotion recognition	an average of 1 year	A neuropsychologist will sign the number of errors in recognizing each facial emotion expression
Rating of the intensity of facial expressions	an average of 1 year	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
Rating of the valence of facial expressions	an average of 1 year	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.

Secondary Outcome Measures

Name	Time	Method
EEG abnormality lateralization and facial emotion recognition	an average of 1 year	The investigators will include in statistical analysis the side (dominant hemisphere vs. non-dominant) of EEGraphic abnormalities on awake/sleep recordings

Trial Locations

Locations (1)

IRCCS Neuromed; 🇮🇹 Pozzilli, Isernia, Italy