FDA Extends Label of gammaCore for Preventive Treatment of Migraine

The medical technology company, electroCore, has announced the expanded use of their device, gammaCore. The company announced that the United States Food and Drug Administration (US FDA) has granted clearance for their gammaCore device to now be used for the preventive treatment of migraine in adults in addition to already being approved for acute treatment.

What is gammaCore currently used for?

The gammaCore device is indicated for the acute treatment of episodic cluster headache and migraine. It is also used as an add-on therapy for the preventive treatment of cluster headache. It is not cleared for the acute treatment of chronic cluster headache or for use in children at this time.

How does gammaCore work?

The gammaCore is a non-invasive vagus nerve stimulator (nVNS). It is a handheld device that is placed up against the neck where the vagus nerve runs under the skin. It provides electrical stimulation to the vagus nerve, which sends signals to the central nervous system (the brain and spinal cord). Stimulating the vagus nerve may impact pain signaling and inflammation, leading to a decrease in migraine-related pain.

Each stimulation lasts 2 minutes, and different types of headache pain have different numbers of stimulation pulses that should be used. Your doctor will help you determine how many pulses are right for you. There are limits to how many times the gammaCore can be used in a 24-hour period.

What are the side effects of gammaCore?

The most common side effects of gammaCore have been reported during use of the device, and often stop immediately after stimulation is complete. Several of these include:

  • Irritation, discomfort, or redness at the site where the device was used
  • Pain, twitching, or muscle contraction nearby where the device was used, including the face, head, neck, or mouth
  • Dizziness
  • Headache
  • Tingling around the area where the device was used

This is not an exhaustive list of all side effects that can be caused by the gammaCore. Talk with your doctor about what side effects you may be at risk for.

Things to know about gammaCore

Some people should not use gammaCore, as the safety and effectiveness of the device in these groups is not known. Some of these groups include:

  • Children
  • Pregnant women
  • People with a history of cancer or active cancer
  • People with implantable medical devices like pacemakers
  • People with a history of heart conditions or heart rhythm changes
  • People with high blood pressure or narrowing of the arteries in the neck (called carotid atherosclerosis)
  • People who have had surgery to cut their vagus nerve in the past (called a vagotomy)
  • People with a history of seizures, brain aneurysms, tumors, or trauma
  • People with metallic devices, screws, or plates near the neck area

Talk with your doctor about your past medical history and the medications you take before starting gammaCore so they can help determine if it is safe for you to use. They will also help determine how your current migraine treatment regimen will be affected by using gammaCore (if it is affected at all).

The gammaCore device should not be used:

  • While using a mobile phone or another device
  • While driving or operating machinery
  • Near microwave machines or radiographic machines (like MRI or CT machines)
  • If you have an open wound or infection near the treatment location
  • If your skin is wet or you are in the water

Read the full instructions for use to learn more about gammaCore.

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