Neurofeedback-Based Digital Therapeutics for the Diagnosis and Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in Children.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- Swanson, Nolan, and Pelham IV Rating Scale
研究概览
简要总结
A multi-center, randomized controlled trial is being conducted to investigate the efficacy of a novel digital therapeutics (DTx) program that utilizes a cross-training approach between neurofeedback training and executive function training for pediatric patients (aged 6-12) diagnosed with ADHD. This gamified interactive program is designed to improve attention deficits and executive function impairments in pediatric patients with ADHD. It is delivered through an engaging iPad game in a home-based treatment format. Patients will be randomly assigned to one of three groups: medication alone, digital therapeutics alone, or a combination of both interventions. Subjects will undergo 30 treatment sessions over the 8-week period, with each session lasting 30 minutes. Investigators will reassess symptoms of ADHD, executive functions, and objective measures of attention at the end of the treatment. Additionally, questionnaires will be distributed to parents to gather their insights and feedback on the treatment approach. This innovative digital therapeutics approach is expected to improve ADHD symptoms individually and enhance therapeutic outcomes when used alongside conventional drug treatment regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- 否
入选标准
- •Meet the diagnostic criteria established by the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) for ADHD.
- •Digital Cancellation Test total score<50 points.
- •Raven's Standard Progressive Matrices score≥
- •6 years ≤ Age<12 years.
- •No interventions for ADHD received within 4 weeks.
- •No color blindness.
排除标准
- •Patients with organic mental disorders, schizophrenia, bipolar disorder, depressive disorders, and other psychiatric conditions.
- •Patients with comorbid autism spectrum disorder, Tourette's syndrome, and other neurodevelopmental disorders.
- •Patients with comorbid conduct disorders.
- •Patients with severe traumatic brain injury or neurological disorders.
- •Patients with a history of severe somatic diseases.
- •Patients with a history of substance or drug dependency.
研究组 & 干预措施
Medication group
The medication group will take Methylphenidate Hydrochloride Extended-Release Tablets with a fixed dose for eight weeks.
干预措施: Concerta (Drug)
Digital therapeutics group
The digital therapeutics group will complete 30 training sessions within 8 weeks.
干预措施: Digital therapeutics (Device)
Combination group
The combination group will take Methylphenidate Hydrochloride Extended-Release Tablets while undergoing digital therapeutics.
干预措施: Concerta (Drug)
Combination group
The combination group will take Methylphenidate Hydrochloride Extended-Release Tablets while undergoing digital therapeutics.
干预措施: Digital therapeutics (Device)
结局指标
主要结局
Swanson, Nolan, and Pelham IV Rating Scale
时间窗: Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32)
The Swanson, Nolan, and Pelham IV Rating Scales (SNAP-IV) will be completed by parents to assess the severity of ADHD symptoms. The values range from 0 to 3, with lower scores indicating a better outcome.
次要结局
- Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria for ADHD(Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32))
- Questionnaire-Children with Difficulties(Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32))
- Behavior Rating Inventory of Executive Function(Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32))
- Continuous Performance Test(Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32))
- Digital Cancellation Test(Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32))
研究者
Lei Lei, MD
Associate Chief Physician, Principal Investigator
Changhai Hospital