背景:注意力缺陷/多动症(ADHD),如果严重,通常用兴奋剂或非兴奋剂药物治疗。然而,由于副作用,用户更喜欢非药物治疗。迄今为止,替代的非药物治疗仅显示出适度的效果。外部三叉神经刺激(eTNS)风险最小,非侵入性神经调节装置,瞄准三叉神经系统.它在2019年被美国食品和药物管理局(FDA)批准用于ADHD,这是一项针对62名ADHD儿童的概念随机对照试验(RCT)的小证据,显示在夜间真实与假eTNS治疗4周后,ADHD症状得到改善,副作用最小。我们在这里提出了一个更大的验证期IIb研究测试疗效的方案,长期持续的影响和潜在的作用机制。
方法:验证,假控制,双盲,平行臂,多中心IIb期RCT对150名患有ADHD的青少年进行了4周的eTNS,在伦敦招募,朴茨茅斯,还有南安普敦,英国。患有多动症的青少年将被随机分为真实或虚假的eTNS,每晚应用4周。主要结果是研究者管理的父母评定的ADHD评定量表的变化。次要结果是其他临床和认知指标,客观多动症和瞳孔测量,副作用,并维持6个月以上的效果。在4周治疗之前和之后,将使用磁共振成像(MRI)在56名参与者的亚组中测试作用机制。
结论:此多中心IIb期RCT将确认eTNS在更大年龄范围的ADHD儿童和青少年中是否有效,是否改善了认知和其他临床措施,是否在6个月时持续有效,它将测试潜在的大脑机制。结果将确定eTNS作为ADHD的新型非药物治疗是否有效和安全。
背景:2021年2月8日的ISRCTN82129325,https://doi.org/10.1186/ISRCTN82129325。
BACKGROUND: Attention Deficit/Hyperactivity Disorder (ADHD), if severe, is usually treated with stimulant or non-stimulant medication. However, users prefer non-drug treatments due to side effects. Alternative non-medication treatments have so far only shown modest effects. External trigeminal nerve stimulation (eTNS) is a minimal risk, non-invasive neuromodulation device, targeting the trigeminal system. It was approved for ADHD in 2019 by the USA Food and Drug administration (FDA) based on a small proof of concept randomised controlled
trial (RCT) in 62 children with ADHD showing improvement of ADHD symptoms after 4 weeks of nightly real versus sham eTNS with minimal side effects. We present here the protocol of a larger confirmatory phase IIb
study testing efficacy, longer-term persistency of effects and underlying mechanisms of action.
METHODS: A confirmatory, sham-controlled, double-blind, parallel-arm, multi-centre phase IIb RCT of 4 weeks of eTNS in 150 youth with ADHD, recruited in London, Portsmouth, and Southampton, UK. Youth with ADHD will be randomized to either real or sham eTNS, applied nightly for 4 weeks. Primary outcome is the change in the investigator-administered parent rated ADHD rating scale. Secondary outcomes are other clinical and cognitive measures, objective hyperactivity and pupillometry measures, side effects, and maintenance of effects over 6 months. The mechanisms of action will be tested in a subgroup of 56 participants using magnetic resonance imaging (MRI) before and after the 4-week treatment.
CONCLUSIONS: This multi-centre phase IIb RCT will confirm whether eTNS is effective in a larger age range of children and adolescents with ADHD, whether it improves cognition and other clinical measures, whether efficacy persists at 6 months and it will test underlying brain mechanisms. The results will establish whether eTNS is effective and safe as a novel non-pharmacological treatment for ADHD.
BACKGROUND: ISRCTN82129325 on 02/08/2021, https://doi.org/10.1186/ISRCTN82129325 .