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Trial Shows Wearable Device Reduces Migraine Symptoms

Hands covering face

(Victoria Borodinova, Pixabay.

18 Oct. 2021. Results from a clinical trial show a smartphone-wearable system relieves pain and reduces other symptoms in adult patients with chronic migraine. The Nerivio system is made by Theranica Bio-Electronics Ltd. in Netanya, Israel that sponsored the study, with results published in the current (November/December 2021) issue of the journal Pain Reports.

Migraine is a common neurological syndrome causing severe headaches along with nausea, vomiting, and extreme sensitivity to light and sound. In some cases, migraines are preceded by warning episodes called aura including flashes of light, blind spots, or tingling in arms and legs. According to Migraine Research Foundation, some 1 billion people worldwide, including 39 million in the U.S., experience migraines. The disorder affects nearly one in four U.S. households, with three times as many women experiencing migraines than men, as well as 10 percent of children.

The Nerivio system consists of a patch worn on the upper arm, with electrodes sending out neuromodulation pulses that electronically stimulate C-fiber nerves and block pain signals from reaching the brain. C-fiber nerves are one of the pain pathways in the nervous system. When a migraine occurs, the individual straps on the Nerivio patch and activates nerve stimulation through an accompanying smartphone app for about 20 minutes. The app’s software also checks for proper placement of the patch, monitors the neuromodulation session, and can link to health care providers that need to be alerted.

As reported by Science & Enterprise, FDA in May 2019 cleared the Nerivio system to treat acute migraines in adults. Since then, FDA extended clearance for Nerivio to chronic migraines in adults in October 2020, and acute migraines in adolescents in January 2021.

Medication overuse contributes to the problem

Because Nerivio therapy does not involve drugs, the treatments address a drawback of other therapies, namely overuse of medications to treat the disorder. Migraine Research Foundation says medication overuse is the most common reason for migraines evolving from an episodic condition into a chronic disease.

The clinical trial assessed the Nerivio system in 126 adult participants at nine sites in the U.S. with chronic migraines, defined as experiencing migraines at least 15 days a month. The vast majority of participants (87%) were women. Individuals were asked to use the system for four weeks, starting treatment with the device within an hour of first experiencing symptoms.

Participants then completed an online diary indicating pain levels on a four-point scale from none to severe, at the time of treatment, then 2 and 24 hours after treatment. In addition, participants recorded presence or absence of other symptoms: nausea, vomiting, light and sound sensitivity, and functional ability or disability. The study had no control or comparison group.

Of the 126 initial participants, 91 completed the trial. Results show among those completing the study, six in 10 (59%) reported less pain within two hours of treatment, the trial’s main success measure, and 21 percent said their pain disappeared. Roughly six in 10 participants reported sustained pain relief for the next 24 hours (64%) and improvement in functional abilities (59%). Likewise four to five in 10 participants reported disappearance of their nausea or vomiting (49%), or sound and light sensitivity symptoms (41% and 45% respectively). One participant reported an adverse event from Nerivio, mild pain in the arm where the device was worn, resolved within 24 hours without medication.

“To the best of our knowledge,” says Theranica’s chief scientist Liron Rabany in a company statement released through Cision, “this was the largest clinical trial of acute treatment of migraine specifically targeting chronic migraine patients.” Rabany, a co-author of the paper adds, “All people with migraine, adults or adolescents, should have the option of discussing a non-pharmacological therapy with their health care providers, as a first-line treatment option, or as an adjunct.”

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