FDA Approves Device to Help Curb Cluster Headaches

Cluster headaches, though rare, are among the most severe forms of headache a person can face.

But there's new hope for at least some patients. The U.S. Food and Drug Administration said it has approved a hand-held device to treat these attacks.

The noninvasive device, called gammaCore, works to reduce cluster headache pain by transmitting mild electrical stimulation to the vagus nerve through the skin on the neck. This is a large nerve that runs from the brain to the colon.

One headache specialist said effective therapies are needed.

Cluster headaches "can be devastating to a person," said Dr. Noah Rosen.

"Although they are uncommon, affecting about 1 in 2,000, they are severe, disabling and poorly understood," said Rosen, who directs Northwell Health's Headache Center in Great Neck, N.Y.

While certain medications such as sumatriptan (Imitrex) are used to quell headaches, they don't always work for cluster headaches.

"Attacks that occur six or more times a day can't effectively be treated with sumatriptan safely, given the maximum daily dosage," Rosen noted.

The newly approved device might offer an alternative for at least some patients with cluster headache, however.

The gammaCore technology is made by the U.S.-based neuroscience and technology company electroCore. FDA approval of gammaCore was based on two clinical trials that found the device was more effective than placebo in reducing cluster headache pain.

One trial of 85 patients with episodic cluster headache found that it reduced pain in about a third of patients compared to about 10 percent of those on placebo.

A second trial of 27 patients found that "a significantly higher percentage of attacks were pain-free" for people using the device compared to those on placebo -- meaning that their pain had ceased by 15 minutes after headache.

According to a company news release, "gammaCore was found to be safe and well-tolerated," with most side effects being "mild and transient."

There were some caveats, however. The device should not be used by patients with an active implantable medical device, such as a pacemaker, hearing aid implant or any implanted electronic device; those diagnosed with narrowing of the arteries; those who have had surgery to cut the vagus nerve in the neck; people with clinically significant high or low blood pressure or certain irregular heart rhythms; and children or pregnant women.

It should also not be used by patients with a metallic device such as a stent, bone plate or bone screw implanted in or near the neck, or patients who are using another medical device at the same time or any portable electronic device (for example, a mobile phone).

For some cluster headache patients, gammaCore "offers a hope for a different treatment approach," Rosen said, and "may be another option for this needful community."

Dr. Sami Saba is a neurologist at Lenox Hill Hospital in New York City.

He explained that cluster headaches are thought to arise because of an abnormality in the body's autonomic nervous system. GammaCore may work because it stimulates the vagus nerve, which "also modulates the autonomic nervous system," Saba explained.

In that sense, it may be treating the origins of the painful headaches, "as opposed to merely treating the symptoms," he said.

Still, Saba pointed out that the device did not help the majority of the participants in the two studies.

GammaCore is currently available in Europe and some other parts of the world, and is expected to be available in the United States later this year, according to the news release.