New Vagus Nerve Stimulator Approved to Treat Cluster Headaches

The U.S. Food and Drug Administration (FDA) has approved a device to treat cluster headaches. The device, called gammaCore®, is a vagus nerve stimulator. The vagus nerve is the longest cranial nerve, extending from the brain through the chest and into the abdomen. With its long and wandering path, the vagus nerve touches many organs and systems in the body and plays a role in regulating pain.1,2

While the exact way gammaCore works on cluster headaches isn’t clear, the device stimulates the nerve non-invasively and is believed to help block the pain signals that cause cluster headaches. Cluster headaches are rare but cause significant, disabling pain. They happen in groups (clusters) and more commonly affect men than women.1,2

About gammaCore

GammaCore is made by a company called electroCore. It is a small, handheld device that transmits a mild electrical stimulation to the vagus nerve through the skin. Patients can use the device at home, applying a conductive gel and positioning the device on the neck where the vagus nerve passes. The dose of gammaCore – the length of stimulation – is two minutes, and patients can give themselves three two-minute doses with 10 second breaks in between each dose. The doses can be administered on one side of the neck or alternately switching sides. If the pain of the cluster headaches remains after three doses, the patient is advised to wait three minutes before applying an additional three doses. The maximum recommended dose in a day is 24 stimulations.2

In clinical trials, gammaCore was compared to sham treatment (a device that does not produce an effect to act as a placebo). Just over a quarter of those with cluster headache who used gammaCore received benefit from the treatment, compared to about 15% of those receiving sham treatment. When studying those with episodic cluster headache, gammaCore was effective in about a third of patients.1

Important information to know about gammaCore

GammaCore is indicated for the treatment of acute pain from episodic cluster headaches in adult patients. Other devices that should not be used at the same time as gammaCore include a TENS unit, muscle stimulator, or any portable electronic device, including mobile phones.2

Talk to your doctor about all your health conditions and whether gammaCore is right for you. GammaCore should not be used in children, pregnant women, people with narrowing of the arteries (carotid atherosclerosis), people who have had surgery to cut the vagus nerve in the neck (cervical vagotomy), people with an active implantable medical device (including a pacemaker or hearing aid implant), people with a metallic device (including a stent, bone plate, or bone screw) implanted in or near their neck, or people with conditions such as cancer, history of brain tumor, aneurysms, head trauma, seizures, high blood pressure (hypertension), low blood pressure (hypotension), bradycardia, or tachycardia.2

The device has not been proven to be effective in preventing cluster headaches, and the long-term effects of the device have not been evaluated. GammaCore can be used in combination with medications for cluster headaches.2

Potential side effects with gammaCore

GammaCore may cause shortness of breath, hoarseness, a change in voice, muscle twitching, discomfort or pain at the application site, and a change in taste. These side effects should resolve after treatment is finished. Some side effects may last after the dose is complete, including skin irritation, tingling or “pins and needles,” fainting, dizziness, sweating, fatigue, depressed mood, ringing in the ears (tinnitus), a progression of headache symptoms, diarrhea, or an abnormal heart rhythm.2

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