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Acute treatment of migraine in children aged 6-11: Real-world analysis of remote electrical neuromodulation (REN)
Klaus Werner1, Trevor Gerson2, Alit Stark-Inbar3
1Division of Pediatric Neurology Duke University Medical Center Durham North Carolina USA.
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.
