An article published in Headache describes the promise of remote electric neuromodulation (REN) as an alternative to current therapies and a potential first-line therapy for acute treatment of migraine. The authors note that REN may be particularly suitable for individuals who experience side effects from or have contraindications to medications for migraine.
The article reviews the results of a pilot (NCT02453399) and pivotal study (NCT03361423) investigating efficacy and safety of a smartphone-connected prescription wearable device (Nerivio; Theranica Bio-Electronics, Netanya, Israel). With active stimulation, 67.6% of migraine attacks treated had pain relief at 2 hours vs 38.8% of those treated with sham stimulation (P < .0001). Freedom from pain at 2 hours was achieved for 37.4% of actively treated attacks vs 18.4% of sham-treated attacks (P = .003). Clinical benefits were maintained in subsequent attacks for individuals independently of pain level prior to treatment. Rates of adverse events were similar for attacks treated actively as with sham. Most adverse events were transient sensations of arm/hand numbness, redness, or mild warmth. Importantly, pain-relief and freedom-from-pain rates were similar between REN treatment and pharmacologic treatment.
Patients can control the strength of the therapy via their smartphone and easily share data with healthcare providers.
"While migraine is one of the most prevalent and disabling neurological diseases affecting a significant portion of the global population, many are still looking for an effective, long-term treatment option," said Alan Rapoport, MD, professor of neurology, UCLA. "For the first time, REN offers an effective, safe and noninvasive alternative for acute migraine treatment and may be suitable as a first-line therapy for some users."
Participants treated their migraine attacks, as soon as possible after a migraine attack began and always within 1 hour of onset, with the device at a perceptible but non-painful intensity level and recorded the intensity of their headache at baseline and 2 and 48 hours after treatment. The REN device is thought to alleviates migraine symptoms by stimulating the body's conditioned pain modulation (CPM) response, in which one painful stimulus modulates pain in other regions of the body. The therapy is the first to use REN to stimulate CPM by placing a device on the upper arm at the onset of a migraine.
Vanessa Baute Penry, MD; Rachana Gandhi Mehta, MD; and Fatemeh Sadeghifar, BS
Alexis Dallara-Marsh, MD
Marwa Kaisey, MD, and Nancy L. Sicotte MD, FAAN