gammaCore

gammaCoreTM (non-invasive vagus nerve stimulator)

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.

About gammaCore

gammaCore is a non-drug, non-invasive vagus nerve stimulator (nVNS) treatment indicated for adjunctive use for the preventive treatment of cluster headache and for the relief of pain associated with episodic cluster headache and migraine in adult patients. It is also the only FDA cleared therapy for the prevention of cluster headache.

gammaCore is available by prescription and is not a drug, so there is no need to inject, inhale, or ingest medication. gammaCore can also be used with other medications, as necessary.1

gammaCore uses a patented electrical stimulation to gently activate your vagus nerve. The vagus nerve plays a role in regulating pain. Stimulating the vagus nerve can block signals that cause cluster and migraine pain.

gammaCore Sapphire™, the next generation of gammaCore therapy, is designed for ease of use and comfort.

  • A sleek, small handheld body that is easy to grip
  • Smooth stimulation surfaces for easy placement over the vagus nerve
  • Intensity buttons positioned on the side of the device for easy stimulation adjustments
  • A large, bright display to communicate status information, even in the dark

Each gammaCore prescription lasts for 31-days. gammaCore Sapphire is activated monthly through a unique, prescription-only gammaCore Refill Card. Check out this video to see how to use gammaCore Sapphire.

gammaCore Clinical trials

Effective for the Adjunctive Use for the Preventive Treatment of Cluster Headache

In one of the largest clinical trial programs conducted of chronic cluster headache prevention, when gammaCore was added to the standard of care, the following was shown:

  • About 1 out of 2 patients experienced a 50% or greater reduction in the number of weekly attacks4
  • On average, patients had a 57% reduction in the frequency of acute medication use4

Effective for the Treatment of Acute Pain Associated with Episodic Cluster Headache

In one of the largest clinical trial programs conducted in cluster headache, gammaCore was shown to be an effective and safe treatment for patients suffering from episodic cluster headache. For many patients, gammaCore provided:

  • Fast relief in as soon as 15 minutes1-3
  • Reliable relief working in at least half of treated attacks1-3
  • Reduction in the duration and intensity of attacks1-3

gammaCARE

As part of the gammaCore experience, patients who have been prescribed gammaCore are invited to enroll in the gammaCARE program for support and resources throughout their journey.

  • gammaCARE Co-pay Assist: Qualified patients may be eligible for copay assistance.*
  • gammaCARE Call Connect: Talk with a Care Specialist who can answer questions about gammaCore, co-pay assistance, and how to use gammaCore Sapphire when you call 1-844-632-9264, Monday-Friday, 8AM-8PM ET.
  • gammaCARE Text Program: Patients may text JOIN to 75686 to get helpful information on cluster headache, gammaCore reimbursement support, refill reminders and financial information or text FIND to 75686 to access Physician Finder.

For more information about gammaCore visit www.gammaCore.com.

*Terms and conditions can be found at https://gammacore.com/terms-and-conditions/.

Indication and Important Safety Information

gammaCore (non-invasive vagus nerve stimulator) is intended to provide non-invasive vagus nerve stimulation (nVNS) on the side of the neck. gammaCore is indicated for:

  • Adjunctive use for the preventive treatment of cluster headache in adult patients.
  • The acute treatment of pain associated with episodic cluster headache in adult patients.
  • The acute treatment of pain associated with migraine headache in adult patients.
  • The safety and effectiveness of gammaCore (nVNS) have not been established in the acute treatment of chronic cluster headache
  • gammaCore has not been shown to be effective for the preventive treatment of migraine headache
  • The long-term effects of the chronic use of gammaCore have not been evaluated
  • Safety and efficacy of gammaCore have not been evaluated in the following patients:
    • 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 (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.

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, Inc.; 2018. 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. 3. Goadsby PJ, de Coo IF, Silver N, et al; ACT2 Study Group. Non-invasive vagus nerve stimulation for the acute treatment of episodic and chronic cluster headache: a randomized, double-blind, sham-controlled ACT2 study. Cephalalgia. 2018;38(5):959-969. 4. Gaul C, Diener HC, Silver N, et al; PREVA Study Group. Non-invasive vagus nerve stimulation for PREVention and Acute treatment of chronic cluster headache (PREVA): a randomised controlled study. Cephalalgia. 2016;36(6):534-546. 5. Gaul C, Magis D, Liebler E, Straube A. Effects of non-invasive vagus nerve stimulation on attack frequency over time and expanded response rates in patients with chronic cluster headache: a post hoc analysis of the randomised, controlled PREVA study. J Headache Pain. 2017;18(1):22.