While all of us have experienced the dull pain of a headache and some know the recurrent pulse and throbbing of migraine, few people can understand the severity of pain associated with cluster headache, also known as “suicide headache.”

What is cluster headache?

Cluster headache is an extremely painful primary headache disorder characterized by recurring unilateral attacks, or attacks that occur on one side of the head. It is called “cluster” headache because headaches typically occur in bouts (or “clusters”) for 6 to 12 weeks, often at the same time each year or day, and are more frequent at night. It begins as sharp pain centered at the eye, temple or forehead, and can be as brief as 15 minutes or as long as several hours. Attacks can strike up to 8 times a day.

The condition, which affects about one to two people in every 1,000, predominantly occurs in males, with symptoms typically manifesting by the age of 30. Those at greater risk of cluster headache include heavy smokers and individuals with a family history of the condition.

“Cluster headache is one of the most painful conditions an individual can experience, known for being potentially more excruciating and debilitating than migraine,” said Stephen Silberstein, M.D., from the Jefferson Headache Center at Thomas Jefferson University in Philadelphia, Pennsylvania. “Sadly, patients diagnosed with cluster headache commit suicide twenty times more than the national average as the pain can be described as unbearable.”

Diagnosis and treatment

Unfortunately, diagnosis of cluster headache may be delayed significantly due to patients and physicians mistaking the end of a bout for resolution of a separate, standalone condition.

Historically, even after the proper diagnosis is made, there have been very few viable therapies for cluster headache, making prevention and treatment strategies a challenge. While the exact cause of cluster headache is unknown, it is typically treated with injectable sumatriptan, a combination of oxygen and various drugs and/or nerve blocks. These methods are associated with barriers to use including a myriad of pharmaceutical side effects. Not surprisingly, 79 percent of patients have been dissatisfied with available treatment options.[1]

Today, patients now have a novel treatment option called gammaCore®(nVNS). gammaCore, the first non-invasive vagus nerve stimulation therapy applied at the neck for the acute treatment of pain associated with migraine and episodic cluster headaches in adult patients, offers a way to treat symptoms without many of the side effects and dose limitations observed with commonly prescribed treatments or the need for invasive and costly procedures. Patients prescribed gammaCore can have reliable access to treatment for up to four cluster attacks per day for 30 days.

“gammaCore has shifted the paradigm by allowing patients to self-administer non-invasive vagus nerve stimulation therapy for acute treatment of cluster headache, resulting in the reduction of pain,” notes Dr. Silberstein. “gammaCore’s efficacy and safety profiles, along with its self-administered mode of delivery, have the potential to not only reduce the side-effect burden associated with other medications but also bring much needed relief to patients.”

For more information on cluster headache and treatment with gammaCore (non-invasive vagus nerve stimulator), visit http://gammacore.com/.

Important Safety Information

gammaCore (non-invasive vagus nerve stimulator) is indicated for the acute treatment of pain associated with episodic cluster headache and migraine in adult patients.

• The safety and effectiveness of the gammaCore non-invasive vagus nerve stimulator (nVNS) has not been established in the acute treatment of chronic cluster headache.

• gammaCore has not been shown to be effective for the prophylactic treatment of migraine headache, chronic cluster headache, or episodic cluster headache.

• The long-term effects of the chronic use of gammaCore have not been evaluated.

• Safety and efficacy of gammaCore has not been evaluated in the following patients, and therefore is NOT indicated for patients with an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device; patients diagnosed with narrowing of the arteries (carotid atherosclerosis); patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy); pediatric patients; pregnant women; patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia.

• Patients should not use gammaCore if they have a metallic device such as a stent, bone plate, or bone screw implanted at or near their neck or are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone)

Note: This list is not all-inclusive. Please refer to the gammaCore Instructions for Use for all of the important warnings and precautions before using or prescribing this product.

gammaCore is available by prescription only. U.S. Federal Law restricts this device to sale by or on the order of a licensed healthcare provider.