数字疗法治疗儿童注意缺陷多动障碍的非劣效性随机对照试验

Non-inferiority randomized controlled trial of digital therapeutics for children with attention-deficit/hyperactivity disorder

摘要

目的 评估一种基于非侵入式脑机接口的数字疗法在改善儿童注意缺陷多动障碍(ADHD)核心症状方面是否不劣于药物治疗,为ADHD提供新的非药物干预选择。方法 采用非劣效性随机对照试验设计,招募2023年2月至2025年2月于上海长海医院和上海长征医院儿科门诊就诊的ADHD患儿,随机分配至数字疗法组或药物组。干预持续8周:数字疗法组居家完成30次训练,药物组接受盐酸哌甲酯缓释片治疗。主要结局指标为8周时SNAP-Ⅳ量表总分变化值(非劣效界值Δ=4),次要结局指标包括执行功能行为评定量表、数字划消测试和儿童困难问卷的变化值。结果 共纳入122例受试者,99例完成随访(数字疗法组50例,药物组49例)。协方差分析显示,在全分析集中,SNAP-Ⅳ量表总分变化值的组间差异为0.26(95%CI:-1.58～2.10),置信区间下限(-1.58)高于非劣效界值(-4),支持非劣效性结论;符合方案集分析结果一致,组间差异为-0.59(95%CI:-2.93～1.76)。次要结局指标组间差异均无统计学意义(P>0.05)。结论 数字疗法在改善ADHD核心症状方面不劣于传统药物治疗,且具有良好的依从性和安全性,可作为ADHD的非药物干预或补充治疗方案。

Abstract

Objective To evaluate whether a digital therapy based on non-invasive brain-computer interface is non-inferior to pharmacological treatment in children with attention-deficit/hyperactivity disorder (ADHD), so as to provide a new non-pharmacological intervention option for ADHD. Methods A non-inferiority randomized controlled trial was conducted.Children diagnosed with ADHD at the pediatric outpatient clinic of Shanghai Changhai Hospital and Shanghai Changzheng Hospital between February 2023 and February 2025 were enrolled and randomly assigned to either a digital therapeutics group or a medication group.The digital therapeutics group completed 30 home-based training sessions over 8 weeks, while the medication group received sustained-release methylphenidate hydrochloride for 8 weeks.The primary outcome was the change in SNAP-Ⅳ total score from baseline to the eighth week (non-inferiority margin Δ=4).Secondary outcomes included changes in the Behavior Rating Inventory of Executive Function (BRIEF), Digital Cancellation Test (DCT), and Questionnaire-Children with Difficulties (QCD). Results A total of 122 participants were enrolled, with 99 completing follow-up (50 in the digital therapeutics group, 49 in the medication group).Analysis of covariance showed that in the full analysis set, the between-group difference in the change of SNAP-Ⅳ total score was 0.26 (95%CI: -1.58 to 2.10), and the lower bound of the 95% confidence interval (-1.58) was above the non-inferiority margin (-4), indicating that digital therapeutics was non-inferior to pharmacological treatment in improving core symptoms of ADHD.Results were consistent in the per-protocol set, with a between-group difference of -0.59 (95%CI: -2.93 to 1.76).No statistically significant differences were observed in secondary outcomes(P＞0.05). Conclusion The digital therapeutics is non-inferior to conventional pharmacological treatment in improving core symptoms of ADHD, with a good compliance and safety profile, and may serve as a potential non-pharmacological intervention or complementary treatment option for ADHD.

关键词

注意缺陷多动障碍 / 数字疗法 / 非劣效性 / 神经反馈 / 执行功能 / 随机对照试验

Key words

attention-deficit/hyperactivity disorder / digital therapeutics / non-inferiority / neurofeedback / executive function / randomized controlled trial

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基金资助

军委后勤保障部卫生局面上项目(21JSZ05)