The Effect of the Mobile EEG-Neurofeedback in Healthy Child and Adolescent Participants: a Randomized Sham-control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Comparisons of the means of children's self-scale variables
研究概览
简要总结
The objective of this study was to ascertain the therapeutic impact of mobile neurofeedback (MNF) in neurotypical children when compared to sham MNF. Clinical assessments were conducted both before and after the MNF intervention, and the effectiveness of the intervention was to be validated through these evaluations.
详细描述
Neurotypical children aged 10-15 participated in the study. All subjects were assessed using the Kiddie Schedule for Affective Disorders and Schizophrenia Present and Lifetime Version Korean Version (K-SADS-PL-K) and confirmed to have no psychiatric symptoms. The participants were randomly assigned to the MNF active (N=31) or sham control (N=30) groups. The MNF program was administered using a mobile app (equipped with a headset with a 2-channel EEG sensor) for 30 min/day, 3 days/week, for 3 months. All participants and their parents completed self-report scales and participants complete neurocognitive function assessments including the continuous performance test, Stroop, children's color trails test-1 and 2, and intelligence test at baseline and after the 3-month MNF program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 8 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Child participants ranging from 8 to 15 years of age, who were recruited from the Department of Psychiatry at Daegu Catholic University Medical Center between 2019 and 2021
排除标准
- •History of congenital genetic diseases History of brain damage History of neurological disorders History of psychiatric conditions such as schizophrenia spectrum disorder, autism spectrum disorder, obsessive-compulsive disorder, major depressive disorder, or bipolar disorder Participants with an IQ below 70, as determined by the Korean-Wechsler Intelligence Scale for Children-Fourth Edition (K-WISC-IV)
结局指标
主要结局
Comparisons of the means of children's self-scale variables
时间窗: through study completion, an average of 1 year
Participants' condition regarding internet addiction, among other factors, was assessed using children's self-scales such as the Korea Internet Addiction Scale (K-scale).
次要结局
- Comparisons of the means of parents' self-scale variables : Beck Anxiety Inventory (BAI)(through study completion, an average of 1 year)
- Comparisons of the means of children's Stroop(through study completion, an average of 1 year)
- Comparisons of the means of parents' self-scale variables : Beck Depression Inventory-II (BDI-II)(through study completion, an average of 1 year)
- Comparisons of the means of children's K-WISC-IV(Korean Wechsler Intelligence Scale for Children-IV)(through study completion, an average of 1 year)
- Comparisons of the means of children's ATA(Advanced Test of Attention)(through study completion, an average of 1 year)
- Comparisons of the means of children's CCTT(Children's Color Trails Test)(through study completion, an average of 1 year)
研究者
Junwon Kim
Clinical professor
Daegu Catholic University Medical Center