A remote electrical neuromodulation (REN) device may offer a safe and effective non-pharmacologic alternative for acute migraine treatment, according to randomized double-blind study results published in Headache.1

Migraine is one of the most prevalent and disabling disorders, and with minimal effective treatments available, there is a great unmet need for alternative acute migraine treatments that are both effective and well tolerated.2 REN (Nerivio Migra®, Theranica Bio-Electronics Ltd., Israel) is a wireless wearable battery-operated stimulation unit controlled by a smartphone software application that stimulates upper arm peripheral nerves to induce conditioned pain modulation.1

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A previous pilot study demonstrated that REN can significantly reduce headaches;3 therefore researchers conducted a sham-controlled study at several sites in the United States and Israel in 252 adults with 2 to 8 migraine headaches per month.1 The smartphone-controlled wireless device was applied for 30 to 45 minutes on the upper arm within 1 hour of attack onset. The researchers found that active stimulation was more effective than placebo in achieving pain relief (66.7% vs 33.8%; P <.0001), pain-free (37.4% vs 18.4%; P =.003), and most bothersome symptom relief (46.3% vs 22.2%; P =.0008) at 2 hours post-treatment. In addition, the pain relief and pain-free superiority of the active treatment was sustained for 48 hours post-treatment, and the incidence of device-related adverse events was low and similar in both treatment groups.

Study limitations include a low rate of severe baseline pain intensity and high rate of mild pain intensity. Investigators also did not evaluate the efficacy of the intervention at a period beyond 1 hour of symptom onset. Further, they acknowledge difficulty in selecting a sham device for significant blinding in neuromodulation studies for migraine.

“Our findings suggest that REN is an effective acute migraine treatment with a favorable safety and tolerability profile,” stated the investigators.1 They added that, “REN has the potential to increase patient adherence, improve migraine management, and improve the health and quality of life of people with migraine.”

References

1. Yarnitsky D, Dodick DW, Grosberg BM, et al. Remote electrical neuromodulation (REN) relieves acute migraine: a randomized, double-blind, placebo-controlled, multicenter trial [published online April 18, 2019]. Headache. doi:10.1111/head.13551

2. Vos T, Abajobir AA, Abate KH, et al. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: A systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017;390:1211-1259.

3. Yarnitsky D, Volokh L, Ironi A, et al. Nonpainful remote electrical stimulation alleviates episodic migraine pain. Neurology. 2017;88:1250-1255.