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Device Shown to Reduce Migraine Occurrence

Headache pain

(R. Nial Bradshaw, Flickr)

7 July 2017. A clinical trial shows an electronic device worn with headphones reduces the number of days with migraines among people with a history of their occurrence. Results of the trial testing the device, made by the company Scion NeuroStim in Raleigh, North Carolina, appears in the 27 June issue of the journal Headache (paid subscription required).

Migraine is a 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. The web site Migraine.com estimates 37 million people in the U.S. suffer from migraines, and cites World Health Organization data indicating migraines affect 18 percent of American women and 7 percent of men.

A team from Scion NeuroStim, Duke University, and University of Kent in the U.K. conducted the clinical trial testing a technique known as caloric vestibular stimulation, or CVS, that seeks to restore functions of the brain stem, a region of the brain associated with the onset of migraines. Among those brain stem functions is balance, where CVS activates responses to imbalance feelings, such as when the head turns quickly. CVS uses changes in temperature that change the density of fluids in the ear canals, helping restore balance and reduce stress on the brain stem.

Up to recently, CVS treatments employed irrigators in the ear with air or water to change the temperature of fluids in the ear canals, but these devices were designed for clinics and not meant to be used for extended periods of time. Scion NeuroStim’s device, however, is a compact electronic earpiece that fits inside padded headphones, like those for music, and heats or cools ear canal fluids. The earpieces sense the temperature of the fluids and send heat or cool air to restore proper temperatures. A handheld controller is attached to the earpieces.

The clinical trial tested the Scion NeuroStim device as a preventive treatment for migraines. The research team recruited 81 adults in the U.S. and U.K. who experienced one or more migraine episodes in the previous 6 months. Participants were randomly assigned to use the CVS device or a sham system twice a day for 3 months. The researchers looked primarily at the number of days per month participants reported migraines over that period, but also changes in the use of pain medication and subjective pain scores, as well as effects on mood, cognition, and balance.

The results show participants using the CVS device reported nearly 4 fewer days per month with migraines, compared to about 1 fewer day per month for those using the sham device, a statistically reliable difference. CVS device users also reported fewer days taking pain medication and lower subjective pain scores. No adverse effects on mood, cognition, or balance were reported, nor did any unexpected adverse events occur among participants.

Another clinical trial of the device with a larger number of participants is expected to begin this summer, also recruiting participants in the U.S. and U.K.

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