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临床试验/NCT03465566
NCT03465566Unknown不适用

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

Neuromed IRCCS1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年11月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
1
主要终点
Rating of the arousal of facial expressions

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
6 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Rating of the arousal of facial expressions

时间窗: an average of 1 year

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.

Number (total amount) of errors in facial emotion recognition

时间窗: an average of 1 year

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

Rating of the intensity of facial expressions

时间窗: an average of 1 year

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

Rating of the valence of facial expressions

时间窗: an average of 1 year

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.

次要结局

  • EEG abnormality lateralization and facial emotion recognition(an average of 1 year)

研究者

发起方
Neuromed IRCCS
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alfredo D'Aniello

Medical Doctor, Neurologist and Psychiatrist of child, Principal investigator

Neuromed IRCCS

研究点 (1)

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