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

Epilepsy, Rolandic Clinical Trial

— BECTS  

Official title:

Facial Emotion Decoding in Benign Partial Epilepsy of Childhood With Centrotemporal Spikes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03465566
• Other study ID #: DGN01
• Status: Recruiting
• Start date: November 1, 2018
• Est. completion date: March 1, 2020

Study information

• Verified date: October 2018
• Source: Neuromed IRCCS
• Contact: Alfredo D'Aniello, MD
• Phone: 0039865929528
• Email: alfredod[@]vodafone.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 11 Years

Eligibility

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)

Related Conditions & MeSH terms

• BECTS
• Epilepsy
• Epilepsy, Rolandic

Intervention

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.

Locations

Country	Name	City	State
Italy	IRCCS Neuromed	Pozzilli	Isernia

Sponsors (1)

Lead Sponsor	Collaborator
Neuromed IRCCS

Country where clinical trial is conducted

Italy, 

References & 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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