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临床试验/NCT04467658
NCT04467658已完成不适用

Neurophysiological Marker of Attention Deficit Hyperactivity Disorder in Children

Daegu Catholic University Medical Center1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2018年8月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
140
试验地点
1
主要终点
QEEG topographical plots of the results of the statistical comparisons to normative values (z-scores) using Neuroguide software

研究概览

简要总结

This study investigated quantitative electroencephalography (QEEG) subtypes as auxiliary tools to assess Attention Deficit Hyperactivity Disorder (ADHD). Patient assessed using the Korean version of the Diagnostic Interview Schedule for Children Version IV and were assigned to one of three groups: ADHD, ADHD-Not Otherwise specified (NOS), and Neurotypical (NT). The investigators measure absolute and relative EEG power in 19 channels and conducted an auditory continuous performance test. The investigators analyzed QEEG according to the frequency range: delta (1-4 Hz), theta (4-8 Hz), slow alpha (8-10 Hz), fast alpha (10-13.5 Hz), and beta (13.5-30 Hz). The subjects were then grouped by Ward's method of cluster analysis using the squared Euclidian distance to measure dissimilarities.

详细描述

Participants between 7 and 12 years of age diagnosed with ADHD according to the DSM-5 criteria were included in the study. The ADHD diagnosis was based on a Korean version of the Diagnostic Interview Schedule for Children Version IV (DISC-IV), which is a structured interview tool, and these diagnoses were confirmed by multiple child and adolescent psychiatrists. If participants did not meet the ADHD diagnostic criteria of DSM-IV and DISC-IV, they were assigned to the Neurotypical (NT) group. Based on the results of the DISC-IV test, participants were assigned to the ADHD or Non-Other Specified (NOS) group. Patients who met the diagnostic criteria of ADHD in DSM-IV, but whose score did not exceed six, and had a score of more than three in the attention deficit or hyperactivity/impactivity scale of DISC-IV were included in the NOS group. Children with a history of brain damage, neurological disorders, genetic disorders, substance dependence, epilepsy, or any other mental disorder were excluded from participation. Children with an IQ of 70 or lower according to the Korean-Wechsler Intelligence Scale for Children (Fourth Edition) or who were receiving drug treatment were also excluded from this study. The EEG recordings were performed using a SynAmps2 direct-current (DC) amplifier and a 10-20 layout 64-channel Quick-Cap electrode-placement system (Neuroscan Inc., NC, USA). The EEG data were digitally recorded from 19 gold cup electrodes placed according to the international 10-20 system. The impedances were maintained below 5 kΩ, and the sampling rate was 1000 Hz. The investigators use the linked mastoid reference and two additional bipolar electrodes to measure horizontal and vertical eye movements. During the recording, each participant laid in a dimly lit, electrically shielded, sound-attenuated room. Resting EEG recordings were recorded after three minutes with the participants' eyes closed.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
7 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Participants between 7 and 12 years of age diagnosed with ADHD according to the DSM-5 criteria were included in the study

排除标准

  • Children with a history of brain damage, neurological disorders, genetic disorders, substance dependence, epilepsy, or any other mental disorder were excluded from participation.
  • Children with an IQ of 70 or lower according to the Korean-Wechsler Intelligence Scale for Children (Fourth Edition) or who were receiving drug treatment were also excluded from this study

结局指标

主要结局

QEEG topographical plots of the results of the statistical comparisons to normative values (z-scores) using Neuroguide software

时间窗: through study completion, an average of 1 year

The investigators measures QEEG on first outpatient clinic and conduct topography for mapping

次要结局

未报告次要终点

研究者

发起方
Daegu Catholic University Medical Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Junwon Kim

Clinical professor

Daegu Catholic University Medical Center

研究点 (1)

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