gammaCore

Non-invasive vagus nerve stimulation (nVNS) for treatment of pain associated with episodic cluster headache

 

Content on this page is for informational purposes, and is not meant to substitute or replace qualified advice from your healthcare provider. Always consult with a licensed physician to see what treatment options are right for you.

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

About gammaCore

gammaCore is a new treatment option available by prescription for patients suffering from pain associated with episodic cluster headache. gammaCore is not a drug, so there is no need to inject, inhale, or ingest medication. It is a portable, hand-held device that uses nVNS, which can be used safely at home.1

Using gammaCore to stimulate the vagus nerve can help block pain signals caused by cluster attacks. gammaCore was proven safe and effective in 2 clinical trials and can be used to treat multiple attacks per day.1,2

Learn more about gammaCore.

Clinical trials of gammaCore

In 2 clinical trials with over 250 patients suffering from cluster headache, gammaCore provided fast relief within 15 minutes of an attack and was well tolerated. gammaCore was not found to be effective among chronic cluster headache patients.1,2

See how gammaCore performed in clinical trials.

 

 

 

gammaCore Patient Registry (GPR) and gammaCARE

If your healthcare provider prescribes gammaCore to treat pain associated with episodic cluster headache, you have the opportunity to enroll in GPR. The information you share will help electroCore advance its understanding of cluster headache. If you qualify, you may be eligible to receive 2 months of gammaCore at no cost to you and up to 1-year co-pay assistance. For more information about GPR, how to enroll, or to find a center near you, please call 1-888-903-CORE (2673) Monday – Friday 8 AM – 6 PM ET.

gammaCARE™ is a patient support program that offers access to online resources, one-on-one training, and co-pay assistance. gammaCARE is available to all gammaCore patients.

Indication and Important Safety Information

gammaCore (nVNS) is indicated for the acute treatment of pain associated with episodic cluster headache in adult patients.

  • The safety and effectiveness of gammaCore has not been established in the acute treatment of chronic Cluster Headache.
  • This device has not been shown to be effective for the prophylactic treatment of chronic or episodic cluster headache.
  • The long-term effects of the chronic use of the device 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
    • Are using another device at the same time (eg,TENS Unit, muscle stimulator) or any portable  electronic device (eg, 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.

Available by prescription only. US Federal Law restricts this device to sale by or on the order of a licensed healthcare provider.

References: 1. gammaCore Instructions for Use. Basking Ridge, NJ: electroCore, LLC.; 2017. 2. Silberstein SD, Mechtler LL, Kudrow DB, et al; Act1 Study Group. Non-invasive vagus nerve stimulation for the acute treatment of cluster headache: findings from the randomized, double-blind, sham-controlled ACT1 study. Headache. 2016;56(8):1317-1332.