Department of Neurology, Wuhan Children's Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430019, Hubei, China.
Beijing Maidehaike Medical Technology Co., Ltd, Beijing, China.
Sci Rep. 2024 Oct 10;14(1):23733. doi: 10.1038/s41598-024-73934-3.
To evaluate the efficacy and safety of digital therapy for children aged 6 to 12 years with attention deficit hyperactivity disorder (ADHD). From January to March 2023, 52 children aged 6 to 12 years with attention deficit hyperactivity disorder (ADHD) from Wuhan Children's Hospital, Hubei Province, China were selected for intervention using the "MindPro1" attention training software developed by Jiangsu Ruinao Qizhi Medical Technology Co., Ltd. Before the intervention, the children were in a stable treatment state, and no modifications were made to the original treatment plan during the MindPro1 intervention. Subjects with severe mental illness or other conditions that may affect the implementation and evaluation of disease treatment were excluded. Subjects completed the planned 4-week intervention, and changes in attention-related variables were assessed using the Test of Attention Variables (TOVA) and the parent version of the 18-item SNAP-IV scale (Swanson, Nolan, and Pelham, version IV scale) before and after the intervention. After 4 weeks of intervention, the lower limit of the 95% confidence interval of the response rate of the 18-item SNAP-IV-Parent scale, which was ≥ 30% improvement from baseline, was higher than 27.5% (better than similar products on the market); the SNAP-IV parent score improved (P < 0.001), with statistical significance; the TOVA-ACS score improved (P < 0.05), with statistical significance. The acceptance rate of parents of children was 100%, and the average compliance rate was 95%. There were 4 cases (7.69%) of adverse reactions that may be related to the device in this trial, which recovered spontaneously within 2 days of discontinuation, and no serious adverse events occurred. After 4 weeks of treatment with ADHD auxiliary treatment software, the objective attention assessment data and attention function assessment scale were significantly improved. Parents had a high acceptance of the software, the average compliance rate of participants was high, and the incidence of related adverse events was low and mild.
为了评估数字疗法对 6 至 12 岁注意力缺陷多动障碍（ADHD）儿童的疗效和安全性。2023 年 1 月至 3 月，从中国湖北省武汉儿童医院选择了 52 名 6 至 12 岁患有注意力缺陷多动障碍（ADHD）的儿童，使用江苏睿能科技有限公司开发的“MindPro1”注意力训练软件进行干预。在干预之前，儿童处于稳定的治疗状态，在“MindPro1”干预期间，未对原始治疗计划进行任何修改。排除有严重精神疾病或其他可能影响疾病治疗实施和评估的情况的患者。受试者完成了计划的 4 周干预，使用注意力变量测试（TOVA）和 18 项 SNAP-IV 父母版本（Swanson、Nolan 和 Pelham，第 IV 版量表）在干预前后评估注意力相关变量的变化。经过 4 周的干预，18 项 SNAP-IV-Parent 量表反应率的 95%置信区间下限≥30%从基线改善，高于 27.5%（优于市场上类似产品）；SNAP-IV 父母评分提高（P<0.001），有统计学意义；TOVA-ACS 评分提高（P<0.05），有统计学意义。患儿家长接受率为 100%，平均依从率为 95%。本试验中有 4 例（7.69%）可能与设备相关的不良反应，停药后 2 天内自发恢复，无严重不良事件发生。经过 4 周的 ADHD 辅助治疗软件治疗，客观注意力评估数据和注意力功能评估量表明显改善。家长对软件的接受度较高，参与者的平均依从率较高，相关不良事件的发生率低且程度较轻。
