Nerivio Remote Electrical Neuromodulation Safe and Effective in Children With Migraine, Study Shows
In pediatric patients, the average treatment intensity was 22.8% of the maximum stimulator intensity, with slightly lower intensity levels compared to previous studies in adolescents and adults.
Klaus Werner, MD, PhD
A recently published study (NCT06138756) of children ages 6-11 years showed that treatment with Theranica’s Nerivio remote electrical neuromodulation (REN) wearable device was safe and effective as an acute migraine treatment in this age population. Based on these data, providers and families seeking an effective, alternative, pill- and needle-free option for children dealing with migraine may consider REN.1,2
Nerivio, a non-drug option for both acute migraine attacks and prevention of migraine with or without aura, has been FDA-approved for several years in adolescents and adults aged 12 and older. It currently remains under FDA review to possibly expand its indication to include those aged 8 years and older. To date, the treatment landscape acute migraine in children aged 6-12 is extremely limited, as rizatriptan is the only cleared pharmacologic treatment available in this age group.
Led by Klaus Werner, MD, PhD, a pediatric neurologist at Duke Health, the study featured 293 children with a median age of 11 used the REN device to treat at least 1 migraine attack and were therefore included in the study. Of them, 18.4% reported at least 1 attack with aura, and the remaining 81.6% never reported aura. Two-thirds (67.4%) of REN treatments were not followed by another REN treatment within 24 h, indicating no retreatment and implying no recurrence within 24 h.
In total, 5493 REN treatments were used, with no adverse events (AEs) and no device-related AEs recorded among treated patients. An additional analyses assessing the number of device-related customer support inquiries revealed an average of 0.072 inquiries per child, which was similar to the inquiry rate of the entire population of REN users of all ages (0.067; P = .725).
In terms of efficacy, results at 2 hours post-treatment showed that consistent efficacy in at least 50% of treatments was found in 72.2% (13 of 18) of patients for pain relief, 36.0% (9 of 25) for pain freedom, 83.3% (15 of 18) for functional disability relief, and 38.9% (7 of 18) for functional disability freedom. Consistent 2 h post-treatment freedom from associated migraine symptoms in at least 50% of the treatments per patient in which the patient reported an associated symptom at baseline was 70.0% (7 of 10) for nausea/vomiting, 50.0% (4 of 8) for phonophobia, and 22.2% (2 of 9) for photophobia. Freedom from at least 1 associated symptom was reported by 63.6% (7 of 11) of patients.
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"What motivated my colleagues and me at our clinic to explore the use of REN with our young patients is the combination of limited options for treating young children and the high safety of this novel drug-free therapy, which we experienced when treating adolescents,” Werner said in a statement.1
Throughout the study, the use or avoidance of a rescue medication to treat headache pain was voluntarily reported in 304 treatments. Of these, REN was used as a standalone therapy in 45.4% (137 of 304) of treatments, while 34.4% (104 of 304) used a combination of REN and over-the-counter medications, and only 20.9% (63 of 304) used REN in combination with other prescribed medications. When using REN alone, without any rescue medication, nearly 3 of 4 (72.2%) children achieved relief from severe or moderate headaches, reducing them to mild or no headaches in at least 50% of their treatments.
In this population of younger patients, the average treatment intensity was 22.8% (±9.6%) of the max stimulator intensity, with a median of 20.5%. Overall, these statistics used in a real-world setting by children were similar yet slightly lower than what was measured in a previous study of adolescents (mean of 26.7 [±12.2]) and even lower than the average intensity used by an adult-based study (31.0 [±13.5]).
"At Theranica, we are focused on developing therapies for people with migraine who face limitations in using traditional drug treatments, with adolescents being a significant part of that segment," co-author Alit Stark Inbar, PhD, vice president of Medical Information at Theranica, said in a statement.1 "With young patients in mind, we meticulously developed the Nerivio REN wearable ensuring it could be used safely and discreetly at school and without disrupting their daily activities. Our goal now is to build on the successful use of the Nerivio REN wearable and - subject to future FDA clearance - be able to offer this treatment to ages even younger than 12, who have less options for treating the disease."
