Vibrating Armband Approved For Migraine Prevention
A vibrating armband that eases migraine pain has just received FDA (Food and Drug Administration) approval for preventative treatment in the US.
The battery-powered Nerivio device, developed by Israeli startup Theranica, is already approved there as treatment for acute migraines.
The device delivers 18 treatments. Doctors can now prescribe those treatments to prevent migraines, as well as to treat them, for patients over the age of 12.
In clinical trials, 248 participants received either the real treatment or a placebo wearable every other day for eight weeks.
Participants who used Nerivio experienced a mean reduction of four migraine days per month from baseline compared to a reduction of only 1.2 days in the placebo group.
They also experienced significant reductions in the average number of headache days of all severities, and in the number of days during which they required medication for acute migraines.
The results were published in the journal Headache, the journal of the American Headache Society.
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Patients place the device on the upper arm as soon as the migraine starts, which vibrates at an intensity just below their pain threshold for 45 minutes.
Nerve fibers in the body deliver a message to the brain, where it decides that the sensation is harmless and releases neurotransmitters to prevent the sufferer from feeling pain.
“Nerivio was purposely built to meet the real-life needs of people living with migraine,” said Alon Ironi, CEO of Theranica.
“While there is an established desire for effective non-drug options, especially for adolescents, migraine care needs to treat the whole person given the nature of this long-term disease.”
“With this in mind, we developed an innovative wearable with a personalized wraparound care plan. Nerivio is paving a bold path forward in migraine treatment and prevention for adolescents and adults. We are hopeful this expanded dual-use indication will have a tremendous impact on mitigating the burden of migraine symptoms and improving patient quality of life.”