Remote Electrical Neuromodulation for the Acute Treatment of Migraine in Patients with Chronic Migraine: An Open-Label Pilot Study

Hida Nierenburg, Julio R Vieira, Nirit Lev, Tamar Lin, Dagan Harris, Maya Vizel, Alon Ironi, Bryan Lewis, Paul Wright, Hida Nierenburg, Julio R Vieira, Nirit Lev, Tamar Lin, Dagan Harris, Maya Vizel, Alon Ironi, Bryan Lewis, Paul Wright

Abstract

Introduction: Remote electrical neuromodulation (REN) is a novel acute treatment of migraine. Upper arm peripheral nerves are stimulated to induce conditioned pain modulation (CPM)-an endogenous analgesic mechanism in which conditioning stimulation inhibits pain in remote body regions. The REN device (Nerivio®, Theranica Bio-Electronics LTD., Israel) is FDA-authorized for acute treatment of migraine in adults who do not have chronic migraine. The current study assessed the consistency of response over multiple migraine attacks in people with chronic migraine who are typically characterized with severe pain intensity, high disability, and less robust response to triptans.

Methods: This was an open-label, single-arm, dual-center study conducted on adults with chronic migraine. Participants underwent a 4-week treatment phase in which they treated their migraine headaches with the device for 45 min within 1 h of attack onset. Pain levels were recorded at baseline, 2 h, and 24 h post-treatment. Efficacy outcomes (pain relief and pain-free responses at 2 h, sustained pain relief and sustained pain-free responses at 24 h) focused on intra-individual consistency of response across multiple attacks, which was defined as response in at least 50% of the treatments.

Results: Forty-two participants were enrolled, and 38 participants were evaluable for analyses; 73.7% (28/38) achieved pain relief at 2 h, 26.3% (10/38) were pain-free at 2 h, 84.4% (27/32) had sustained pain relief response at 24 h and 45.0% (9/20) had sustained pain relief response at 24 h in at least 50% of their treated attacks. The effects of REN on associated symptoms and improvement in function were also consistent. The incidence of device-related adverse events was low (1.8%).

Conclusions: REN used for a series of migraine attacks was effective and well tolerated across attacks. REN may offer a safe and effective non-pharmacological alternative for acute treatment in patients with chronic migraine.

Trial registration: ClinicalTrials.gov identifier, NCT04161807. Retrospectively registered on November 13, 2019.

Keywords: Acute migraine treatment; Chronic migraine; Consistency; Headache; Medication overuse headache; Nerivio; Remote electrical neuromodulation.

Figures

Fig. 1
Fig. 1
Illustration of the REN device
Fig. 2
Fig. 2
Disposition of participants
Fig. 3
Fig. 3
Consistency of pain response. a Percentage of participants achieving pain relief and pain-free at 2 h response in at least 50% of treated attacks. b Percentage of participants achieving sustained pain relief at 24 h and sustained pain-free response in at least 50% of treated attacks. The error bars represent 95% confidence intervals
Fig. 4
Fig. 4
Pain relief and pain-free responses at 2 h post-treatment across multiple treatments

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