Two hours post-treatment with the remote electrical neuromodulation device resulted in the improvement of nausea, photophobia, phonophobia, and functional ability.
Newly published data on Theranica’s remote electrical neuromodulation (REN) device, Nerivio, showed that the acute treatment is safe and provides relief of migraine headaches and associated symptoms in patients with chronic migraine (CM).1,2
The prospective, open-label trial (NCT04194008), aimed to validate and provide further evidence on the safety and effectiveness of Nerivio in a cohort of 126 patients with CM treated for 4 weeks. Using an electronic diary to record their symptoms, investigators recorded the percentage of subjects who achieved pain relief at 2 hours posttreatment as the primary end point. Pain freedom and improvement of associated symptoms and functional disability were secondary end points.
Of the 91 individuals who had evaluable treatment with REN, 54 (59.3%) achieved pain relief and 19 (20.9%) achieved pain disappearance at 2 hours. Additionally, 64.4% of those who achieved pain relief at that time point had sustained pain relief at 24 hours following treatment.
"People with chronic migraine not only have a higher frequency of migraine attacks, but their attacks tend to be more severe than episodic migraine patients. They typically need to take more medications, usually cocktails of preventive and acute medications," lead author Brian Grosberg, MD, director, Hartford Healthcare Headache Center, said in a statement.1 "The challenge is to relieve the migraine symptoms while avoiding the risk of medication overuse headache (MOH) and other complications. Nonpharmacological interventions such as REN help meet this need by providing a drug-free treatment option. As a clinically validated, nonpharmacological acute treatment option for people with migraine, Nerivio is an excellent fit for fulfilling this need."
All told, 48.8% (20 of 41 [95% CI, 32.8-64.8]), 40.5% (30 of 74 [95% CI, 29.2-52.5]) and 44.6% (29 of 65 [95% CI, 32.2-57.4]) of participants experienced disappearance of vomiting, photophobia, and phonophobia, respectively, following treatment with REN. Furthermore, 59.4% (19 of 32 [95% CI, 40.6-76.3]) of individuals experienced improvement in functional ability at 2 hours.2
The safety analysis included 99 individuals who received the device. Of them, 9 patients (9.1% [95% CI, 4.2-16.6]) experienced at least 1 adverse event (AE), and only 1 individual experienced a device-related AE, which was pain in the arm that the device was on. This AE was mild and resolved within 24 hours without medication. Non-device related AEs observed included sinus infection (n = 1), upper respiratory infection (n = 2), ear infection (n = 1), viral infection (n = 1), tooth infection (n = 1), leg pain (n = 1), and poison ivy rash (n = 1). There were no discontinuations due to AEs.2
"To the best of our knowledge, this was the largest clinical trial of acute treatment of migraine specifically targeting chronic migraine patients," Liron Rabany, PhD, chief scientist, Theranica, and coauthor of the study paper said in a statement.1 "We are determined to continue our clinical development, adding ever-increasing solid evidence of the clinical benefit that REN brings to different subpopulations of people with migraine. All people with migraine, adults or adolescents, should have the option of discussing a nonpharmacological therapy with their healthcare providers, as a first-line treatment."
Nerivio is the first FDA-cleared smartphone-controlled prescribed wearable device for the acute treatment of migraine and has had its efficacy confirmed in multiple different studies. Most recently, the device was found to be safe and effective to treat women who experience menstrually related or pure menstrual migraine.Among a cohort of 91 women aged 18 to 55 years, 74.7% (n = 68) reported that the treatment was at least moderately effective (moderately effective, 37.4%; very effective, 26.4%; extremely effective, 11%) in treating menstrual migraine.3