gammaCore device in use (ElectroCore Inc.)
24 Jan. 2020. A clinical trial is underway testing a handheld non-invasive device that stimulates a major nerve in the body, as a way to prevent migraines. The trial is assessing a device called the gammaCore, made by ElectroCore Inc. in Basking Ridge, New Jersey, at 30 sites in the U.S.
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.
The gammaCore is a device about the size of a mobile phone that stimulates the vagus nerve pathway, which extends from the brain stem to the abdomen, connecting other major organs including the heart, esophagus, and lungs. Impulses are sent along the nerve to the brain stem, which then sends signals to areas of the brain. Vagus nerve stimulation is used in various forms to treat symptoms of epilepsy and depression, but usually requires implanted devices or electrodes.
Patients place the gammaCore device for two minutes against the vagus nerve at the spot on the neck where the cartoid pulse is located. Signals from the device, says ElectroCore, stimulate fibers in the vagus nerve that extend to the brain stem. There, the signals stimulate release of neurotransmitters, amino acids in the brain that may reduce other brain chemicals known to excite nerve cells, thus reducing pain.
The latest model of gammaCore, called the Sapphire, is cleared by FDA to treat migraine and related episodic cluster headaches in adults. The clinical trial, sponsored by ElectroCore, is testing the device to prevent rather than treat migraines. The study plans to enroll 500 adult participants with a history of migraines, and who experience from eight to 20 headaches per month. Individuals are randomly assigned to use either the gammaCore or a sham device that looks and feels like a gammaCore, but does not send out any electrical impulses.
Participants will use the gammaCore or sham device three times a day for 12 weeks, following a month-long period without treatment, where the study team measures occurrences of headaches as a baseline measure. Researchers are looking primarily for the average reduction in number of days with headaches during the last four weeks of the 12-week test period, as well as any signs of adverse effects from the treatments.
One of the test sites is University of West Virginia in Morgantown, where the lead investigator, neurology professor Umer Najib, asked that the study be extended for another 12 weeks in an open-label phase giving all participants a chance to use the real gammaCore device.
“A significant portion of our patients do not have commercial insurance,” says Najib in a university statement, “and even if a device is FDA-approved, they aren’t able to get it because state Medicaid won’t cover it for them. I advocated for the open-label phase to be added to this clinical trial as this gives our patients the opportunity to receive the latest neuromodulation treatments.”
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