Chronic migraine is particularly devastating. It affects school work, extracurricular activities, and quality of life, including relationships with other family members, and can also influence the mental health of both the migraineurs and family members. According to the International Classification of Headache Disorders, 3rd edition (ICHD-3), chronic migraine is defined as 15 or more headache days per month for greater than three months, where at least on eight days per month, there are features of migraine headache. Although botulinum toxin type A (BoNTA) has been proven effective for treating chronic migraine in adults, little literature exists about its use in children. Here, we present the treatment response in children with chronic migraines treated with BoNTA at our institutions Duke and State University of New York (SUNY) Upstate. A retrospective analysis of 30 adolescent migraineurs who met ICHD-3 criteria for chronic migraine were treated with BoNTA injection according to the standardized adult protocol. Descriptive statistics and paired t-tests were performed. A total of 185 units of botulinum toxin were injected intramuscularly per patient, as in addition to the standard 31 sites for a total of 155 units, an additional 30 units were given in areas that were felt to provide further benefit. Participants (n=30) were 16.5 ± 1.83 years old. The headaches were precipitated by trauma in seven cases. All had failed standard pharmacotherapy, including amitriptyline and topiramate. An average of 2.47 ± 1.6 BoNTA injection cycles was performed. Migraine severity decreased significantly from 7.47 ± 1.89 on a 10-point scale to 4.34 ± 3.02 (p<.001). Additionally, headache frequency improved from 24.4 ± 7.49 painful days per month to 14.8 ± 12.52 painful days per month (p<.001). One patient developed nausea related to injections; all others tolerated it well, with no side effects. BoNTA injection was a safe and effective therapy for chronic migraine in our cohort of children recalcitrant to medical therapy. Further research with multi-centered, double-blinded, randomized, placebo-controlled trials is warranted to evaluate the long-term safety and efficacy in this population.

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.

Introduction Remote electrical neuromodulation (REN) is an FDA-cleared, nonsignificant-risk, drug-free, prescribed wearable device (Nerivio^®) for the acute treatment of migraine and/or every other day for prophylactic treatment in patients aged 8 years and older. Despite established efficacy within labeled use parameters, some patients adopt more frequent treatment regimens, including multiple treatments within a single day, daily use, or both. This study assessed the safety and tolerability of REN when used at frequencies exceeding the labeled indication. Methods Real-world observational data from patients with migraine using REN with frequent treatment patterns were collected. Safety assessments evaluated all adverse events (AE) reports, with emphasis on device-related AEs (dAEs), categorized by severity and seriousness per regulatory standards. Results A total of 1863 patients with migraine (82.1% female, mean age of 38.8 ± 20.1 years) were eligible: (1) 1654 treated multiple times a day, at least once, (2) 310 treated daily; 101 patients met both patterns. Safety profile was favorable, with a total of 17 patients reporting dAEs (0.91% of patients, 0.02% of treatments). Of them, 16 dAEs reported in multiple treatments per day group (0.97% of patients, 0.05% of treatments), and 6 dAEs in daily treatment group (1.94% of patients, 0.01% of treatments) with 5 dAEs overlapping between the groups (reported by patients who met both criteria). dAEs were infrequent, negligible to moderate in severity, and resolved without medical intervention. No serious dAEs were observed, and the majority of patients continued to use REN after reporting the dAE. Conclusion REN is a safe and well-tolerated treatment for migraine, even when used more frequently than the labeled indication. These findings support its use in real-world clinical practice, including for patients with severe or highly frequent attacks who may need additional treatments. Trial Registration ClinicalTrial.gov NCT07336056.

Background/Objectives: Omega-3 polyunsaturated fatty acids (PUFAs) influence lipid-mediated inflammatory pathways implicated in migraine, yet randomized trial data evaluating biologic effects of omega-3 supplementation in youth with migraine remain limited. This pilot quasi-randomized clinical trial aimed to determine whether 12 weeks of omega-3 PUFA supplementation produces measurable changes in whole-blood EPA and DHA levels in children and adolescents with migraine, and to characterize changes in patient-reported measures of pain, migraine-related disability, and psychological distress. Methods: We conducted a parallel-group, quasi-randomized, double-blind, placebo-controlled trial in children and adolescents (ages 10–17) with migraine diagnosed per International Classification of Headache Disorders, 3rd edition criteria, recruited from pediatric neurology clinics at two academic medical centers. Of 57 participants allocated 1:1 to daily omega-3 PUFA supplementation (340 mg EPA + 510 mg DHA) or coconut oil placebo for 12 weeks, 44 completed the study and were analyzed. The primary outcome was change in whole-blood omega-3 PUFA index. Secondary outcomes included patient-reported measures of pain intensity, pain interference, migraine-related disability, and psychological distress. Exploratory outcomes included changes in omega-6/omega-3 and arachidonic acid/eicosapentaenoic acid (AA/EPA) ratios. Between-group differences were evaluated using ANCOVA adjusting for baseline values. Results: Omega-3 supplementation significantly altered lipid biomarker profiles. Compared with placebo, the intervention group demonstrated greater increases in omega-3 PUFA index (adjusted mean difference 1.64; 95% CI 0.94–2.35; p < 0.001) and greater reductions in omega-6/omega-3 ratio (−2.57; 95% CI −4.25 to −0.90; p = 0.003) and AA/EPA ratio (−13.52; 95% CI −21.55 to −5.49; p = 0.002), consistent with the increase in whole-blood omega-3 levels. No significant between-group differences were observed in patient-reported outcomes. Conclusions: Omega-3 PUFA supplementation significantly altered lipid biomarker profiles in youth with migraine over 12 weeks, supporting a measurable whole-blood EPA + DHA response in this proof-of-concept trial. Future larger-scale trials with longer duration are needed to evaluate clinical effects.