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Trial Shows Wearable Device Can Reduce Migraine

Nerivio system in use

Nerivio system in use (Theranica Bio-electronics)

18 Oct. 2022. Results from a clinical trial show an electronic device worn on the arm can reduce migraine occurrences in people with history of the condition. Theranica Bio-electronics in Montclair, New Jersey and Netanya, Israel, maker of the Nerivio medical device, released study findings to the media, but are not peer-reviewed.

Migraine is a common disorder, marked by severe headaches as well as nausea, vomiting, and extreme sensitivity to light and sound. Some people with migraines also experience episodes called aura with flashes of light, blind spots, or tingling in arms and legs. The American Migraine Foundation estimates one billion people worldwide and 39 million in the U.S. are affected by migraine, experienced in one in four households. The foundation says migraine affects one in five women, as well as one in 16 men, and one in 11 children.

The Nerivio device, developed by Theranica Bio, is a patch strapped on the upper arm, with electrodes sending out electronic pulses that stimulate C-fiber nerves to invoke conditioned pain modulation. C-fiber nerves are a pain pathway in the nervous system, which when stimulated with non-painful signals, triggers conditioned pain modulation in the brain stem, a process that limits or blocks pain experiences. A companion smartphone app controls the device, and can send data to health care providers if needed.

Theranica Bio first created the Nerivio system as a treatment for migraine. In Oct. 2021, Science & Enterprise reported on a clinical trial of the Nerivio device, used by people with chronic migraine when experiencing migraine episodes. The findings show people using the device experience either less pain within two hours or complete pain relief, as well as fewer associated symptoms, such as nausea, and sensitivity to light and sound. FDA has authorized the Nerivio system as a treatment for episodic and chronic migraine in adults and adolescents.

Fewer pain medications taken

The company is seeking to extend the Nerivio system into prevention of migraines, as well as treat the disorder. The results reported today are from a clinical trial testing Nerivio among 248 individuals with a history of migraine at 16 sites in the U.S. Participants were first assessed for four weeks to count the number of headaches normally experienced in that period, then randomly assigned to use either the Nerivio system or a placebo/sham device sending out electric pulses but not into nerve fibers, once every other day for eight weeks.

The study team looked primarily for changes in the number of days experiencing migraine headaches for Nerivio or placebo/sham device users during the test period, as well as reports of adverse effects. Theranica Bio says Nerivio users experience an average of 4.0 fewer days per month with migraine headaches, compared to 1.3 days on average for the placebo/sham device users, a difference large enough for statistical reliability. The company also reports Nerivio users experience fewer moderate or severe headaches, as well as take fewer pain medications than placebo/sham device users. Only one mild adverse event occurred in the trial, not described by Theranica, by one of the placebo/sham device users.

“There is a growing recognition that certain chronic pain diseases, such as migraine,” says Theranica Bio CEO Alon Ironi in a statement emailed to Science & Enterprise, “may be treated with therapies other than pharmacological agents, or in combination with those. This is validated by clinical evidence from randomized controlled studies such as this one, as well as real-world evidence studies.”

Dagan Harris, the company’s vice-president for clinical and regulatory development adds, “We look forward to working with the FDA on the regulatory clearance process, and, in parallel, to sharing detailed information from the study in peer-reviewed publications and upcoming scientific conferences, and to continue advancing this innovative therapy for the preventive treatment of migraine.”

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