THURSDAY, June 23 (HealthDay News) -- An implantable device hidden in the nape of the neck may mean more headache-free days for people with severe migraines that don't respond to other treatments, a new study suggests.
More than 36 million Americans get migraine headaches, which are marked by intense pain, sensitivity to light and sound, nausea and vomiting, according to the Migraine Research Foundation. Medication and lifestyle changes are the first-line treatments for migraine, but not everyone improves with these measures.
The St. Jude Medical Genesis neurostimulator is a short, thin strip that is implanted behind the neck. A battery pack is then implanted elsewhere in the body. Activating the device stimulates the occipital nerve and can dim the pain of migraine headache.
"There are a large number of patients for whom nothing works and whose lives are ruined by the daily pain of their migraine headache, and this device has the potential to help some of them," said study author Dr. Stephen D. Silberstein, director of the Jefferson Headache Center in Philadelphia.
The study, which was funded by device manufacturer St. Jude Medical Inc., is slated for presentation on Thursday at the International Headache Congress in Berlin, and is the largest study to date on the device. The company is now seeking approval for the device in Europe and then plans to submit their data to the U.S. Food and Drug Administration for approval in the United States.
Researchers tested the new device in 157 people who had severe migraines about 26 days out of each month. After 12 weeks, those who received the new device had seven more headache-free days per month, compared to one more headache-free day per month seen among people in the control group. Individuals in the control arm did not receive stimulation until after the first 12 weeks.
Study participants who received the stimulato
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