Tuesday, March 9, 2021

Remote electrical neuromodulation for acute treatment of migraine in adolescents

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



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 welltolerated 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 BioElectronics Ltd., Israel) is a FDAauthorized 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 openlabel, singlearm, multicenter study in adolescents (ages 12–17 years) with migraine. Participants underwent a 4week runin phase. Eligible participants continued to an 8week treatment phase with the device. Pain severity, associated symptoms, and functional disability were recorded at treatment initiation, and 2 and 24 hours posttreatment. 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 posttreatment 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.


Sixty participants were enrolled for the study; of these, 14 failed to meet the runin criteria and 1 was lost to followup. Fortyfive participants performed at least one treatment, of which 39 participants completed a test treatment with REN. One devicerelated adverse event (2%) was reported in which a temporary feeling of pain in the arm was felt. Pain relief and painfree 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.


REN may offer a safe and effective nonpharmacological alternative for acute treatment in adolescents.

 Courtesy of:  https://www.mdlinx.com/journal-summary/remote-electrical-neuromodulation-for-acute-treatment-of-migraine-in-adolescents/4mq821S5QdC7nEjyPzQHw7

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