Remote electrical neuromodulation useful for adolescents with migraine

 

Current acute treatments for migraine in adolescents are mostly pharmacological but have limitations. Remote electrical neuromodulation provides clinically meaningful relief of migraine pain and associated symptoms, offering a safe and effective non-pharmacological alternative for acute treatment in adolescents [1].

Migraine is a common disabling neurologic disorder in adolescents. The efficacy of pharmacological treatment is limited, can cause side effects, and may lead to medication overuse. There is thus a great unmet need in this group for alternative acute treatments for migraine that are both effective and well tolerated.

Remote electrical neuromodulation is a novel acute treatment of migraine controlled by the patient. It stimulates upper arm peripheral nerves to induce conditioned pain modulation, an endogenous analgesic mechanism in which subthreshold conditioning stimulation inhibits pain in remote body regions. The remote electrical neuromodulation device Nerivio® is FDA-authorised for acute treatment of migraine with or without aura in adults.

The current open-label, single-arm, multicentre study assessed the efficacy and safety of this device in adolescents (aged 12-17 years) with migraine. Preventive treatment was allowed, if stable for ≥2 months and during the study. Enrolled were 60 patients, of whom 14 failed to meet the run-in criteria –having inadequate headache attacks– and 1 was lost to follow-up. Participants underwent a 4-week run-in phase during which the headaches were treated according to usual care and recorded in an electronic migraine diary. Eligible participants continued to an 8-week treatment phase in which they were asked to treat their headaches with the device. Pain severity levels, associated symptoms, and functional disability were recorded at treatment initiation, 2 and 24 hours post treatment.

A test treatment with remote electrical neuromodulation was completed by 39 participants. Pain relief and being pain-free at 2 hours were reported by 71.8% and 35.9% of participants, respectively. Both pain relief and pain-free responses were sustained at 24 hours in 90.9% of participants, as found in an exploratory analysis.

The following symptoms disappeared at 2 hours: nausea in 54.5%, photophobia in 41.9%, and phonophobia in 40.0% of participants. Furthermore, 69.7% of participants experienced improvement of functional ability at 2 hours. A single device-related adverse event was reported, namely a temporary sensation of pain in the arm.

Remote electrical neuromodulation provided clinically meaningful relief of migraine pain and associated symptoms in adolescents with migraine. Most participants achieved pain relief at 2 hours after treatment using the device in most of their treated attacks. In addition, it was well tolerated and safe. Hence, the results suggest that remote electrical neuromodulation can offer a safe and effective non-pharmacological alternative for acute treatment in adolescents with migraine.

 

1. Hershey AD. Remote electrical neuromodulation for the acute treatment of migraine in adolescents. MTIS 2020 Virtual Symposium, abstract MTV20-DP-031.

Posted on 27 October, 20205 November, 2020