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

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.

Study Overview

• Status: Unknown
• Conditions: Epilepsy, Rolandic; BECTS
• Intervention / Treatment: Diagnostic test: IDS;MMSPE;CDI 2;CBCL;tests of facial expression evaluation

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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Italy
  • Isernia
    • Pozzilli, Isernia, Italy, 86077
      • Recruiting
      • IRCCS Neuromed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 11 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Diagnostic test: IDS;MMSPE;CDI 2;CBCL;tests of facial expression evaluation; 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.
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	Diagnostic test: IDS;MMSPE;CDI 2;CBCL;tests of facial expression evaluation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Neuromed IRCCS
• Investigators: Study Director: Giancarlo Di Gennaro, MD, PhD, IRCCS Neuromed

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 1, 2018
• Primary Completion (ANTICIPATED): March 1, 2020
• Study Completion (ANTICIPATED): March 1, 2020

Study Registration Dates

• First Submitted: February 22, 2018
• First Submitted That Met QC Criteria: March 13, 2018
• First Posted (ACTUAL): March 14, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 2, 2018
• Last Update Submitted That Met QC Criteria: October 31, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Emotion; Social cognition; Childhood epilepsy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes; Epilepsies, Partial; Epilepsy; Epilepsy, Rolandic
• Other Study ID Numbers: DGN01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No