Hershey, A.D., Lin, T., Gruper, Y., Harris, D., Ironi, A., Berk, T., Szperka, C.L. and Berenson, F. (2021), Remote electrical neuromodulation for acute treatment of migraine in adolescents. Headache: The Journal of Head and Face Pain, 61: 310-317. https://doi.org/10.1111/head.14042
Abstract
Objectives
Migraine is a common disabling neurological
disorder. Current acute treatments for migraine in adolescents are mostly
pharmacological and may have limited effectiveness, can cause side effects, and
may lead to medication overuse. There is an unmet need for effective and well‐tolerated treatments. Remote electrical
neuromodulation (REN) is a novel acute treatment of migraine that stimulates
upper arm peripheral nerves to induce conditioned pain modulation (CPM)—an
endogenous analgesic mechanism. The REN device (Nerivio®, Theranica Bio‐Electronics
Ltd., Israel) is a FDA‐authorized device for
acute treatment of migraine in adults. This study assessed the efficacy and safety
of REN in adolescents with migraine.
Design and Methods
This was an open‐label, single‐arm, multicenter study in adolescents (ages 12–17 years)
with migraine. Participants underwent a 4‐week run‐in phase. Eligible participants continued to
an 8‐week treatment phase
with the device. Pain severity, associated symptoms, and functional disability
were recorded at treatment initiation, and 2 and 24 hours post‐treatment. The primary endpoints of this study
were related to the safety and tolerability of REN. The secondary endpoints
were related to device efficacy and included the proportion of participants who
achieved pain relief at 2 hours post‐treatment and the proportion of participants
who achieved pain freedom at 2 hours. The presented results reflect an
interim analysis with subsequent stopping of the rest of the study.
Results
Sixty participants were enrolled for the
study; of these, 14 failed to meet the run‐in criteria and 1 was lost to follow‐up. Forty‐five participants performed at least one
treatment, of which 39 participants completed a test treatment with REN. One
device‐related adverse event
(2%) was reported in which a temporary feeling of pain in the arm was felt.
Pain relief and pain‐free at 2 hours
were achieved by 71% (28/39) and 35% (14/39) participants, respectively. At 2 hours,
69% (23/33) participants experienced improvement in functional ability.
Conclusions
REN may offer a safe and effective non‐pharmacological alternative for acute
treatment in adolescents.
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