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Status unknownNCT03465566BECTSUpdated Nov 2, 2018

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

An observational study in BECTS and Epilepsy, Rolandic, sponsored by Neuromed IRCCS. Status unknown at 1 site in Italy. Open to participants aged 6 Years to 11 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-11-02.

Sponsored by Neuromed IRCCS · Observational

The sponsor has not verified this record recently (last verified Oct 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
200
Ages
6 Years to 11 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • BECTS
  • Epilepsy, Rolandic

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Keywords

  • Emotion
  • Social cognition
  • Childhood epilepsy
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In context

Epilepsy, Rolandic

23 studies on the registry are indexed under Epilepsy, Rolandic; 3 are open to participants now.

Browse Epilepsy, Rolandic studies →

Lead sponsor

Neuromed IRCCS is the lead sponsor of 81 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
6 Years to 11 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

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

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • 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

Interventions

  • Diagnostic testIDS;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.

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What researchers measure

Primary outcomes

  1. Number (total amount) of errors in facial emotion recognition

    A neuropsychologist will sign the number of errors in recognizing each facial emotion expression

    Time frame: an average of 1 year

  2. 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

    Time frame: an average of 1 year

  3. 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.

    Time frame: an average of 1 year

  4. 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.

    Time frame: an average of 1 year

Secondary outcomes

  1. 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

    Time frame: an average of 1 year

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Study locations

1 of 1 sites recruiting
  • IRCCS Neuromed
    Pozzilli, Isernia 86077, Italy
    Recruiting
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References and documents

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. PubMed 28796560 ↗
  • 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. PubMed 24892756 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Nov 2018; primary completion for Mar 2020, 16 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 22, 2018
First posted
Mar 14, 2018
StartEst.
Nov 1, 2018
Primary completionEst.
Mar 1, 2020
CompletionEst.
Mar 1, 2020
Last update
Nov 2, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 2, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03465566
Lead sponsor
Neuromed IRCCS
Responsible party
Alfredo D'Aniello (Medical Doctor, Neurologist and Psychiatrist of child, Principal investigator, Neuromed IRCCS) — Principal investigator
First posted
Mar 14, 2018
Start date
Nov 1, 2018 (estimated)
Primary completion
Mar 1, 2020 (estimated)
Completion
Mar 1, 2020 (estimated)
Last update
Nov 2, 2018

Study contacts

Alfredo D'Aniello, MD
Contact
alfredod@vodafone.it
0039865929528
Marco De Risi, PhD
Contact
marcoderisi@inwind.it
0039865929528
Giancarlo Di Gennaro, MD, PhD
study director · IRCCS Neuromed

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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