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

NCT ID: NCT03465566

Last Updated: 2018-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-01

Study Completion Date

2020-03-01

Brief Summary

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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

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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.

Conditions

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BECTS Epilepsy, Rolandic

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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

IDS;MMSPE;CDI 2;CBCL;tests of facial expression evaluation

Intervention Type DIAGNOSTIC_TEST

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

IDS;MMSPE;CDI 2;CBCL;tests of facial expression evaluation

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)
Minimum Eligible Age

6 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Neuromed IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Alfredo D'Aniello

Medical Doctor, Neurologist and Psychiatrist of child, Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Giancarlo Di Gennaro, MD, PhD

Role: STUDY_DIRECTOR

IRCCS Neuromed

Locations

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IRCCS Neuromed

Pozzilli, Isernia, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Alfredo D'Aniello, MD

Role: CONTACT

0039865929528

Marco De Risi, PhD

Role: CONTACT

0039865929528

References

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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.

Reference Type BACKGROUND
PMID: 28796560 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24892756 (View on PubMed)

Other Identifiers

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DGN01

Identifier Type: -

Identifier Source: org_study_id

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