Nerivio REN Device Results in Reduced Treatment Days for Adolescents With Migraine

Teshamae Monteith, MD, FAHS, FAAN

A real-world study (NCT05769322) published in Frontiers in Pain Research demonstrated that frequent use of Theranica’s remote electrical device (REN; Nerivio) as an acute treatment for migraine in adolescents resulted in reductions in mean monthly treatment days in the subsequent months, suggesting a preventive benefit in this subpopulation.

The study included prospective data from 83 eligible adolescents who used REN on at least 10 days every 28-day month, following the REN migraine prevention guideline of an every-other-day pattern. Led by Teshamae Monteith, MD, FAHS, FAAN, associate professor of clinical neurology and chief of the headache division in the department of neurology at the University of Miami Miller School of Medicine, the primary outcome was the reduction in the mean monthly migraine treatment days (MMTD) for 3 months–from the first month of treatment and during 2 subsequent months.

All told, results showed a significant month-to-month decrease in the primary end point of mean MMTD, reducing from 12.6 ([±3.2] 95% CI, 10-23) MMTD in the first month to 9.0 ([±4.8] 95% CI, 3-25) in the second month of consecutive use (t[82] = 7.0; P <.001). The number of MMTD further decreased to 7.4 ([±4.2] 95% CI, 3-19) in the third month (t[82] = 3.5; P <.001), reflecting an additional reduction of 1.6 (±4.1) MMTD in the third month of treatment. Over the course of the 3 observed months, investigators recorded a cumulative decrease of 5.2 (±4.8) MMTDs.

"Using a preventive migraine treatment is highly important for people living with migraine, especially adolescents, who have 5 – 6 monthly headache days or more," Monteith said in a statement. "Adhering to a preventive treatment also may reduce the possibility of further migraine deterioration and chronification. Migraine often starts early around puberty, so it's imperative to quickly diagnose it correctly and apply an effective therapy regime that teenagers can adhere to in the midst of their hectic daily routines."

READ MORE: Patient Headache Questionnaire Leads to Greater Diagnosis Rates, Less Non-Specific Diagnoses in Children

The Nerivio REN device, which has been FDA-approved for several years, applies an electrical waveform designed to activate nociceptive receptors and thus activates an endogenous pain mechanism, called conditioned pain modulation. The waveform is a symmetrical, biphasic, square pulse, with a modulated frequency range of 100-120 Hz, and an adjustable output current of up to 40 mA to the arm. Once switched on, all treatment controls and interactions with the device are done through an easy-to-use smartphone application, which is connected to the device through Bluetooth.

The cohort’s mean age was 15.9 (±1.3) years, with most patients being female (89%) and most experiencing aura and/or 1 migraine-associated symptom on at least 1 occasion (95.1%). At the conclusion of the study, treatment with Nerivio resulted in consistent acute pain response over a 2-hour period in at least 50% of treated attacks. Specifically, 61.9% (26 of 42) of adolescent frequent users reported pain relief, 24.5% (12 of 49) achieved pain freedom, 67.4% (31 of 46) experienced relief from functional disability, and 41.3% (19 of 46) achieved functional disability freedom.

Additional findings showed that some treated patients had consistent 2-hour disappearance of associated symptoms in at least 50% of the attacks in which such symptom was reported at the beginning of treatment. These included disappearance of photophobia (39.5%; 15 of 38), phonophobia (50%; 17 of 34), nausea/vomiting (65.9%; 14 of 23), and at least 1 associated symptom (65.9%; 27 of 41) of the adolescent patients. In terms of safety, there was a single report of a minor-device-related adverse event (AE), in which the user reported arm pain that subsequently resolved after the treatment. There were no systemic or serious AEs reported.

"We carefully designed Nerivio considering how adolescents would be able to use it safely and discreetly at school, without having to approach the school nurse, while they continue their daily routine of classes and social and sports activities," investigator Alit Stark Inbar, PhD, vice president of Medical Information at Theranica, said in a statement.¹ "Practice guidelines from the American Academy of Neurology (AAN) and American Headache Society (AHS) suggest that preventive treatments should be considered for adolescents if the frequency and severity of headaches leads to migraine-related disability. However, evidence-based options for adolescents are limited, and some families hesitate to use prescription medications. Our non-pharmacological, FDA-cleared 'combo' therapy offers effective, easy relief at home or school, and is a beneficial dual-use addition to the clinicians' toolbox."

REFERENCES
1. New study found preventive impact in adolescents who frequently used Nerivio for abortive treatment of migraine. News release. Theranica. November 28, 2023. Accessed December 11, 2023. https://www.prnewswire.com/news-releases/new-study-found-preventive-impact-in-adolescents-who-frequently-used-nerivio-for-abortive-treatment-of-migraine-301997988.html
2. Monteith TS, Stark-Inbar A, Shmuely S, et al. Remote electrical neuromodulation (REN) wearable device for adolescents with migraine: a real-world study of high-frequency abortive treatment suggests preventive effects. Front Pain Res. 2023;6(4). doi:10.3389/fpain.2023.1247313