Edemann-Callesen Henriette, Huus Christel-Mie Lykke, Karstoft Caroline, Bjarnadóttir Elín, Bikic Aida, Jeppesen Pia, Martinsen Ørjan G, Pettersen Fred Johan, Lindschou Jane, Juul Sophie, Quistgaard Maria, Gluud Christian, Storebø Ole Jakob
Center for Evidence-Based Psychiatry, Psychiatric Research Unit, Psychiatry Region Zealand, Fælledvej 6, 4. Floor, 4200, Slagelse, Denmark.
Research Unit of Child and Adolescent Psychiatry in Southern Denmark, Odense, Denmark.
Eur Child Adolesc Psychiatry. 2025 Jun 16. doi: 10.1007/s00787-025-02786-7.
External trigeminal nerve stimulation (eTNS) is a non-invasive technique involving external cutaneous stimulation of the trigeminal nerve. In 2019, the Monarch eTNS device was approved as a treatment for children with attention-deficit/hyperactivity disorder (ADHD). The Monarch eTNS device is designed to be applied at home, which offers a certain level of convenience but also necessitates a high degree of compliance and acceptability from the families. To assess the feasibility of - and pilot a larger randomized clinical trial investigating the Monarch eTNS device versus sham for patients aged 7 to 17 years with ADHD. We will conduct a parallel-group, sham-controlled, feasibility randomised clinical trial. We will include 60 children and adolescents (aged 7 to 17 years) diagnosed with ADHD from three clinical sites in Denmark. Patients will be randomised to 4 weeks of active versus sham eTNS. Feasibility outcomes include completion of the trial; the number of eligible participants who consent to inclusion; treatment compliance; acceptability of the intervention and completion. Adverse events will be monitored throughout the trial. Exploratory clinical outcomes include ADHD core symptoms (primary) and several secondary outcomes. Autonomic functions will be evaluated by means of heart rate variability, using a heart rate sensor. This trial will allow us to evaluate the feasibility of conducting a larger randomised clinical trial investigating the use of eTNS as a home-based, non-pharmacological intervention for children and adolescents diagnosed with ADHD.Trial registration: ClinicalTrials.gov ID: NCT06655610. Registered 23.10.2024.
经皮三叉神经刺激（eTNS）是一种非侵入性技术，涉及对三叉神经进行外部皮肤刺激。2019年，Monarch eTNS设备被批准用于治疗患有注意力缺陷多动障碍（ADHD）的儿童。Monarch eTNS设备设计为可在家中使用，这提供了一定程度的便利性，但也需要家庭有高度的依从性和接受度。为评估在7至17岁患有ADHD的患者中比较Monarch eTNS设备与假刺激的大型随机临床试验的可行性并进行初步试验。我们将进行一项平行组、假刺激对照的可行性随机临床试验。我们将纳入来自丹麦三个临床地点的60名被诊断患有ADHD的儿童和青少年（7至17岁）。患者将被随机分配接受4周的活性eTNS与假刺激。可行性结果包括试验的完成情况；同意纳入的合格参与者数量；治疗依从性；干预措施的可接受性和完成情况。在整个试验过程中监测不良事件。探索性临床结果包括ADHD核心症状（主要）和几个次要结果。将使用心率传感器通过心率变异性评估自主神经功能。这项试验将使我们能够评估开展一项更大规模随机临床试验的可行性，该试验旨在研究将eTNS作为一种针对被诊断患有ADHD的儿童和青少年的家庭非药物干预措施。试验注册：ClinicalTrials.gov标识符：NCT06655610。于2024年10月23日注册。
