NCT03465566|Unknown
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
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BECTS
Facial Emotion Decoding in Benign Partial Epilepsy of Childhood With Centrotemporal Spikes
Sponsor study identifier
observational
200
1 country
1
Study Start
November 1, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
March 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 22, 2018
Actual (reported)March 14, 2018
Actual (reported)November 1, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
EEG abnormality lateralization and facial emotion recognition
an average of 1 year
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 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
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
IRCCS Neuromed
Pozzilli, Isernia, 86077, Italy
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.
Giancarlo Di Gennaro, MD, PhD
IRCCS Neuromed
First Submitted
February 22, 2018
First Posted
March 14, 2018
Study Start
November 1, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
Sleep Spindles and Memory in Rolandic Epilepsy
Contact the study team to confirm eligibility.
March 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 2, 2018
Record last verified: 2018-10
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Source: ClinicalTrials.gov.
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