Remote Electrical Neuromodulation for Acute Treatment of Migraine in Adolescents

Andrew D. Hershey MD, PhD, FAAN, FAHS; Tamar Lin PhD; Yaron Gruper MSc; Dagan Harris PhD; Alon Ironi MSEE; Thomas Berk MD; Christina L. Szperka MD, MSCE; Frank Berenson MD, FAHS

Disclosures

Headache. 2021;61(2):310-317. 

In This Article

Discussion

This open-label study demonstrates that REN may offer a safe and tolerable acute treatment of migraine in adolescents. The findings of this study extend previous studies establishing the safety and efficacy of REN in adults with migraine.[12,15] Specifically, the findings of this study show that the REN device is safe and well-tolerated. The incidence of device-related adverse events over multiple migraine attacks was low (2.2%), with no device-related serious adverse events. This rate compares favorably to the reported rates for current acute pharmacological treatments.[6]

We also show a clinical benefit of REN for pain relief, pain-free, and disappearance of associated symptoms at 2 hours after acute migraine attack treatment. Pain relief and pain-free responses were sustained 24 hours after treatment. Furthermore, the data reveal consistent response rates from treatment to treatment, with no evidence of reduction in therapeutic benefits over time.

The 2-hour response rates to REN in adolescents (36% pain-free; 72% pain relief) were similar to those reported in adults.[12] Importantly, over 66% of the patients achieved pain relief at 2 hours in more than half of their attacks and over 33% of the patients achieved pain-free at 2 hours in more than half of their attacks, demonstrating consistent efficacy across multiple attacks.[24] Our finding that pain relief and pain-free responses were sustained at 24 hours are also favorable, thought further studies are needed to assess the stability of this effect as these were exploratory outcomes which were assessed on a small number of subjects. We also measured response in at least one of the associated symptoms present at baseline for each attack. This analysis included all associated symptom and not only those considered most bothersome, yet it demonstrates that in 66% of the patients, REN treatments result in the disappearance of at least some of the associated symptoms. Furthermore, our findings demonstrated that REN has an effect on migraine related disability. Approximately 70% of patients reported improved function at 2 hours following REN treatment. Moreover, the average decrease in PedMIDAS scores observed in the current study is similar to the reduction shown for migraine preventive treatments in the pediatric population,[19] suggesting that REN is also effective for improving patients' quality of life.

This study was conducted both on adolescents with chronic migraine (at least 15 headache days per month, with migraine-like headaches on ≥8 days per month) and adolescents with non-chronic migraine. In this study, 11.7% (7/60) of the enrolled patients were adolescents with chronic migraine, of which 4/39 (10.3%) were included in the final analysis set. Although this small sample size precludes subgroup analyses, it suggests that REN may provide a drug-free treatment option for adolescents with migraine independently from the frequency of their migraines.

This study has several limitations. First, the efficacy results are not placebo controlled, which is specifically important in pediatric studies which typically show a higher rate of placebo response in adolescents than adults.[25] However, even if accounting for the high placebo response rate of 55% observed for 2-hour pain relief in previous studies,[26] the therapeutic gain in this study remains clinically meaningful. Second, this study was conducted on a small sample size. Further studies in a larger sample size are warranted.

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