Acute treatment of migraine in children aged 6−11: Real-world analysis of remote electrical neuromodulation (REN)

Annals of the Child Neurology Society Pub Date : 2024-05-21 DOI:10.1002/cns3.20073

Klaus Werner, Trevor Gerson, Alit Stark-Inbar, Sharon Shmuely, Alon Ironi, Christina L. Szperka, Andrew D. Hershey

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Abstract

Objectives

Migraine is a prevalent neurological disorder severely impacting children and adolescents, yet only one pharmacological treatment is approved for ages 6−12 years. Remote electrical neuromodulation (REN) is a nonpharmacological, prescribed, wearable device cleared by the Food and Drug Administration for acute and/or preventive treatment of migraine with or without aura in patients 12 years and older. This study evaluates REN's safety and efficacy in ages 6−11 years.

Methods

Prospective acute treatment of migraine data were collected through the REN device (Nerivio) smartphone application. Endpoints were device safety (primary); consistent treatment efficacy (headache pain, functional disability, associated migraine symptoms), and REN-medication combinations 2 h post-treatment.

Results

Children (n = 293), median age 11 years (interquartile range = 9−11), 73.7% girls, conducted 5493 REN treatments. No adverse events were reported. Efficacy in at least 50% of REN treatments was calculated from all patients who voluntarily reported pain levels, symptoms, and/or disability at treatment onset and at 2 h post-treatment, with 72.2% (13/18) of patients reporting pain relief, 36.0% (9/25) pain freedom, 83.3% (15/18) functional disability relief, and 38.9% (7/18) functional disability freedom. Migraine-associated symptoms disappeared in at least 50% of REN treatments in 70.0% (7/10) of patients for nausea/vomiting, 50.0% (4/8) phonophobia, and 22.2% (2/9) photophobia; 63.6% (7/11) reported freedom from at least one associated symptom. REN was used as a standalone treatment, with over-the-counter medications, and with prescribed headache medications in 45.4%, 34.4%, and 20.9% of treatments, respectively.

Interpretation

REN may serve as a safe and efficacious acute treatment of migraine for children. Providers and families seeking a safe, effective, pill- and needle-free treatment option for children suffering from migraine may consider REN.

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6-11 岁儿童偏头痛的急性治疗：远程电神经调控 (REN) 的实际情况分析

偏头痛是一种严重影响儿童和青少年的流行性神经系统疾病，但只有一种药物治疗方法获准用于 6-12 岁的患者。远程神经电调控（REN）是一种非药物、处方、可穿戴设备，已获得美国食品和药物管理局批准，用于12岁及以上有或无先兆偏头痛患者的急性和/或预防性治疗。本研究评估了REN在6-11岁年龄段的安全性和有效性。通过REN设备（Nerivio）智能手机应用收集了前瞻性偏头痛急性治疗数据。终点为设备安全性（主要）、持续治疗效果（头痛疼痛、功能障碍、相关偏头痛症状）以及治疗后 2 h 的 REN 药物组合。儿童（n = 293），中位年龄 11 岁（四分位间范围 = 9-11），73.7% 为女孩，接受了 5493 次 REN 治疗。无不良反应报告。根据所有自愿报告治疗开始时和治疗后2小时疼痛程度、症状和/或残疾情况的患者计算，至少50%的REN治疗有效，其中72.2%（13/18）的患者报告疼痛缓解，36.0%（9/25）的患者报告疼痛消失，83.3%（15/18）的患者报告功能性残疾缓解，38.9%（7/18）的患者报告功能性残疾消失。在至少 50% 的 REN 治疗中，偏头痛相关症状消失，70.0%（7/10）的患者表示恶心/呕吐症状消失，50.0%（4/8）的患者表示畏声症状消失，22.2%（2/9）的患者表示畏光症状消失；63.6%（7/11）的患者表示至少一种相关症状消失。在45.4%、34.4%和20.9%的治疗中，REN分别作为独立疗法、与非处方药物和处方头痛药物一起使用。为儿童偏头痛患者寻求一种安全、有效、无需药片和针头的治疗方法的医疗机构和家庭可以考虑使用 REN。

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