Near-infrared Spectroscopy Neurofeedback as a Treatment for Children With Attention Deficit Hyperactivity Disorder
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in SNAP-IV
研究概览
简要总结
To observe the clinical efficacy and mechanism of functional near-infrared spectroscopy imaging neurofeedback therapy for attention deficit and hyperactivity disorder.
详细描述
In this study, a parallel controlled study will be conducted to recruit 60 patients with ADHD, 30 patients in the fNIRS group and 30 patients in the drug group. At the same time, 30 healthy controls will be recruited. 6 weeks, 12 sessions of NIRS feedback will be given for participants in NIRS group and healthy controls. 6 weeks of first or second line medication will be given for participants of drug group. Magnetic resonance imaging will be performed at baseline for all participants. SNAP IV, PSQ, CGI will be evaluated at baseline, week 3, week 6 and week 8 for ADHD participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •diagnosed with TD, according to the American Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5);
- •aged 6-12;
- •right handed;
排除标准
- •full-scale intelligence quotient below 80(measured by Wechsler Intelligence Scale for Children，WISC)
- •medical or neurological disorders, psychiatric disorders other than oppositional defiant disorder
- •current participation in a psychotherapeutic treatment
研究组 & 干预措施
Drug group
Children with ADHD, 6 weeks' treatment of either methylphenidate or tomoxetine
干预措施: Methylphenidate or Tomoxetine (Drug)
NIRS group
Children with ADHD, 12 sessions of NIRS feedback, for two sessions per week.
干预措施: NIRS neurofeedback (Behavioral)
Control group
Healthy children, 12 sessions of NIRS feedback, for two sessions per week.
干预措施: NIRS neurofeedback (Behavioral)
结局指标
主要结局
Change in SNAP-IV
时间窗: Baseline, week 3, week 6, week 8
Change in SNAP-IV(Swanson, Nolan, and Pelham-IV rating scales) score between groups over time
次要结局
- Change in TRS(Baseline, week 3, week 6, week 8)
- Change in CGI(Baseline, week 3, week 6, week 8)
- Change in PSQ(Baseline, week 3, week 6, week 8)
研究者
Wu Wenjun-1
Department of Psychiatry, Xijing Hospital, The Air Force Medical University
Xijing Hospital