Klaus Werner, Trevor Gerson, Alit Stark-Inbar, Sharon Shmuely, Alon Ironi, Christina L. Szperka, Andrew D. Hershey
{"title":"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","authors":"Klaus Werner, Trevor Gerson, Alit Stark-Inbar, Sharon Shmuely, Alon Ironi, Christina L. Szperka, Andrew D. Hershey","doi":"10.1002/cns3.20073","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Objectives</h3>\n \n <p>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.</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>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.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>Children (<i>n</i> = 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.</p>\n </section>\n \n <section>\n \n <h3> Interpretation</h3>\n \n <p>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.</p>\n </section>\n </div>","PeriodicalId":72232,"journal":{"name":"Annals of the Child Neurology Society","volume":"2 2","pages":"135-145"},"PeriodicalIF":0.0000,"publicationDate":"2024-05-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/cns3.20073","citationCount":"0","resultStr":"{\"title\":\"Acute treatment of migraine in children aged 6−11: Real-world analysis of remote electrical neuromodulation (REN)\",\"authors\":\"Klaus Werner, Trevor Gerson, Alit Stark-Inbar, Sharon Shmuely, Alon Ironi, Christina L. Szperka, Andrew D. Hershey\",\"doi\":\"10.1002/cns3.20073\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div>\\n \\n \\n <section>\\n \\n <h3> Objectives</h3>\\n \\n <p>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.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Methods</h3>\\n \\n <p>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.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Results</h3>\\n \\n <p>Children (<i>n</i> = 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.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Interpretation</h3>\\n \\n <p>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.</p>\\n </section>\\n </div>\",\"PeriodicalId\":72232,\"journal\":{\"name\":\"Annals of the Child Neurology Society\",\"volume\":\"2 2\",\"pages\":\"135-145\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2024-05-21\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://onlinelibrary.wiley.com/doi/epdf/10.1002/cns3.20073\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Annals of the Child Neurology Society\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://onlinelibrary.wiley.com/doi/10.1002/cns3.20073\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Annals of the Child Neurology Society","FirstCategoryId":"1085","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1002/cns3.20073","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Acute treatment of migraine in children aged 6−11: Real-world analysis of remote electrical neuromodulation (REN)
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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