If your bank account balance looks nail-bitingly low and you won't get paid for days, you might agonize over every dollar you spend. Maybe you'll scrutinize grocery-store ads more closely than usual or brew your own coffee instead of ordering it from a barista.
Migraine patients can face a similar sense of scarcity when it comes to migraine medications. Drugs called triptans are the "mainstay of migraine treatment," said West Virginia University neurologist Umer Najib, but typically, patients can't take them more than twice a week. If they have a third migraine, they're out of luck. But Najib is researching a new way to treat--and prevent--migraine attacks without this limitation: neuromodulation.
"Neuromodulation is a way to manipulate the central pain system by applying electrical or magnetic pulses to specific nerves or areas of the brain," explained Najib, who directs the clinical research program for the School of Medicine's Department of Neurology.
In a new clinical trial he's leading, neuromodulation takes the form of a cell-phone-sized device that stimulates the vagus nerve. The longest cranial nerve in the human body, the vagus nerve charts a circuitous route from the brain stem through the face, neck, chest and abdomen.
The traditional vagus nerve stimulator, which has been used for epilepsy seizure patients for many years, is an implanted device. But this is noninvasive. It works in a different way. It's applied to the neck, and it stimulates the vagus nerve in a proprietary manner that causes changes in certain areas of the brain stem involved in the migraine process. By downregulating those migraine-related areas, it can disrupt an ongoing migraine attack, or if it's used three times a day, every day, it prevents the migraine attacks from coming on." Umer Najib, neurologist, West Virginia University
ElectroCore--a corporation that specializes in neuromodulation technologies--makes the device and funded the trial.
Previous animal studies and medical-imaging data suggest the device is effective at preventing and combatting migraine attacks. Now Najib and his colleagues want to know how well it performs for actual migraine patients. Peering into an 'invisible disease'
The researchers are enrolling participants in a six-month trial that will pit the device against a "sham" version that looks and feels like the real thing but doesn't affect the vagus nerve.
During the first three months, half of the participants will apply the nerve stimulator to their necks for two minutes, three times a day. The other participants will do the same, using the replica. For the next three months of the study--called the "open label phase"--all of the participants will use the real device (open label phase).
"This was something that was dear to me," Najib said. "A significant portion of our patients do not have commercial insurance, 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."
Participants will keep a daily, electronic headache diary. If they skip a day or don't provide all of the information they're asked for, a dashboard will notify the research team, and a coordinator will call the patients, reminding them to complete the task.
Every four weeks, the participants will also visit the WVU Headache Center so that a doctor can assess their migraine symptoms and determine if they're improving.
These symptoms go beyond pain. They can comprise visual auras, dizziness, imbalance, light and sound sensitivity, cognitive slowing, nausea and vomiting. Related Stories
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