Noninvasive Neurostimulator Helps Prevent Cluster Headaches

The portable device provides a mild electrical stimulation to the vagus nerve, without the potential side effects associated with commonly prescribed drugs. The self-administered treatment consists of three consecutive two-minute stimulations twice a day, with the first treatment applied within one hour of waking up and the second seven to 10 hours later; the device does not prevent migraines.

In two clinical studies, nVNS patients had 3.9 fewer cluster attacks per week than those who received standard of care (SOC). In addition, 40% of those patients who received gammaCore in addition to SOC experienced a 50% or greater reduction in weekly cluster attacks, compared to 8.3% of patients who received SOC alone. Also, a 57% decrease in the frequency of abortive medication use among those who received gammaCore plus SOC care was demonstrated, while those patients who received SOC alone did not experience a substantial reduction.

“Clearance of gammaCore for adjunctive use for the preventive treatment of cluster headache has the potential to help the approximately 350,000 Americans impacted by this debilitating condition, often referred to as a suicide headache,” said Frank Amato, CEO of electroCore. “We are pleased that cluster headache patients now have a FDA-cleared option, and one that is both safe and effective, especially given the difficulty in treating cluster headache and the limitations of current treatments.”

Cluster headache is a rare but extremely painful disorder characterized by recurring unilateral attacks. The condition is the least common type of headache disorder, occurring in 1-2 out of 1,000 individuals, affecting predominantly males, heavy smokers and those with a family history. Symptoms typically manifest by age 30. Frequently nicknamed “suicide headache” due to the severity of pain associated with their occurrence, cluster headache bouts occur rapidly and with variable frequency, but often at the same time each year or day and are often more frequent at night.

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