Incorporating Remote Electrical Neuromodulation (REN) Into Usual Care Reduces Acute Migraine Medication Use: An Open-Label Extension Study

Abstract

Background: A recent randomized controlled study showed that 66.7% (66/99) and 37.4% (37/99) of people undergoing remote electrical neuromodulation (REN), a novel non-pharmacological migraine treatment, achieve pain relief and pain freedom, respectively, at 2 h post-treatment. The participants who completed the 6-weeks double-blind phase of this study were offered to participate in an open-label extension (OLE) with an active REN device. Objective: This study investigated the clinical use of REN, focusing on its potential in reducing the use of acute migraine medications. Methods: The parent study for this open-label extension (OLE) was a randomized, double-blind, sham-controlled study of acute treatment conducted on 296 participants enrolled at 12 sites in the USA and Israel. This study included a run-in phase, in which migraine attacks were treated with usual care, and an 8-weeks double-blind treatment phase. One hundred sixty participants continued in an 8-weeks OLE phase in which they could incorporate a REN device into their usual care. Medication use rate (percentage of participants who treated their attacks only with REN and avoided medications in all their attacks) and pain outcomes at 2 h post-treatment were compared between the OLE and the run-in phase in a within-subject design. Results: The analyses were performed on 117 participants with episodic migraine. During the OLE, 89.7% of the participants treated their attacks only with REN and avoided medications in all their attacks compared with 15.4% in the run-in phase (p < 0.0001). The rates of pain relief and pain-free in at least 50% of the treatments at 2 h post-treatment were comparable (pain relief: 58.1% in the run-in phase and 57.3% in the OLE, p = 0.999; pain-free: 23.1% in the run-in vs. 30.8% in the OLE, p = 0.175). Conclusions: REN may reduce the use of acute migraine medications. Thus, incorporating REN into usual care may reduce the risk for medication overuse headache (MOH). Future studies should evaluate whether REN reduces the use of acute migraine medications in a population at risk for MOH.

Keywords: acute treatment; conditioned pain modulation; medication overuse headache; migraine; neuromodulation; remote electrical neuromodulation.

Copyright © 2020 Marmura, Lin, Harris, Ironi and Rosen.

Figures

Figure 1

Enrollment of participants.

Figure 2

Number of attacks treated with different types of acute pharmacological treatments in the run-in phase. A total of 22 of the 404 attacks were excluded from this analysis since the medication type was not specified (participants reported “other” in medication type). AAC, aspirin, acetaminophen, and caffeine; APAP, acetaminophen.

Figure 3

Comparison of medication use patterns. The percentage of participants who treated their attacks only with REN and avoided medications in all their reported attacks in the open-label extension phase (black) compared with the run-in phase (gray). *p < 0.0001.

Figure 4

Comparison of clinical pain outcomes. (A) The percentage of participants achieving pain relief at 2 h post-treatment in a least 50% of their treatments in the open-label extension phase (black) compared with the run-in phase (gray). (B) The percentage of participants achieving pain freedom at 2 h post-treatment in a least 50% of their treatments in the open-label extension phase (black) compared with the run-in phase (gray).