Get to know gammaCore
Information that will help you talk with your patients about gammaCore and the advantages of non-invasive vagus nerve stimulation (nVNS).
Please watch the video below and read through the additional information to learn more about gammaCore™ (non-invasive vagus nerve stimulator). After looking through the sections, click or tap CONTINUE to fill out your information for the physician finder.
Please see Important Safety Information. Please also see the gammaCore Instructions for Use.
gammaCore Sapphire™ (non-invasive vagus nerve stimulator) is indicated for use in adult patients for the preventive treatment of migraine and cluster headache, and acute treatment of pain associated with migraine and episodic cluster headache.
Available by prescription only.
How to use gammaCore Sapphire.
If your patients have an earlier version of gammaCore, direct them to the how-to-use video here.
How to prescribe
If you decide that gammaCore (nVNS) is the right choice for your patients, gammaCore offers an easy, convenient prescribing process.
Simply print and fill out the Patient Enrollment Form and fax to 1-877-427-4186. This form is available 24/7 at gammaCore.com.
The specialty pharmacy will work directly with your patient to review insurance coverage and to confirm shipment details. gammaCore will then be delievered directly to your patient's doorsteps.
Patients can schedule a video or phone call with a registered nurse for 1:1 training by calling (888) 903-CORE.
Mechanism of action3-6
gammaCore (nVNS) safely and gently stimulates the vagus nerve from the outside of the body. This activation of the vagus nerve has been shown to:
Reduce glutamate in the trigeminal nucleus
Suppress neuronal firing in the trigeminocervical complex (TCC)
Suppress cortical spreading depression (CSD) susceptibility
Clinically proven as a safe and effective preventive treatment for migraine1,2,7
A prospective, double-blind, randomized, sham-controlled study evaluated the ability of nVNS to prevent migraine days.
In the PREMIUM study, the preventive use of gammaCore (nVNS) provided a significant reduction in migraine days in treatment-adherent patients.
gammaCore provided patients with:
Significant reduction in migraine days (mITT)1,2
- 25% reduction in migraine days per month from 8 migraine days for patients suffering from episodic migraine.
- Therepeutic gains with nVNS were greater for patients with aura (-2.96 days).
Reliable relief across multiple migraines
- One in three patients had >50% benefit
In PREMIUM, the most common adverse device-related events ≥5% were application site rash (0% vs 6.2%), and application site pain (3% vs. 5.8%) in the gammaCore and sham arm, respectively. Most adverse events were mild and transient and occurred primarily during administration.
Clinically proven as a safe and effective treatment for migraine pain7,8,9
A double-blind, randomized, sham-controlled trial evaluated the efficacy, safety, and tolerability of gammaCore (nVNS) in 243 patients with migraine headache.
In the PRESTO study, gammaCore provided greater relief vs sham. Results were significant at 30 and 60 minutes but not at 120 minutes (primary endpoint).
gammaCore provided patients with:
Fast relief from the first treated migraine
- 3x as many gammaCore patients were pain-free at 30 minutes vs those treated with sham (12.7% vs 4.2%, P=0.012)
- 2x as many patients were pain-free at 60 minutes vs those treated with sham (21% vs 10.0%, P=0.023)
Reliable relief across multiple migraines
- 47.6% of gammaCore patients reported mild or no pain at 120 minutes for ≥50% of all treated headaches vs 32.3% receiving sham (P=0.026)
Reduction in pain intensity for the first migraine
- gammaCore reduced pain intensity over 3x greater than sham at 60 minutes (25.4% vs 7.7%) and over 6x greater at 120 minutes (34.8% vs 5.4%)
gammaCore reduced the need for other rescue medications8
In PRESTO, the most common adverse device-related events ≥2% were application-site discomfort (2.5% vs 0.8%), application-site erythema (0% vs 2.4%), application-site pain (0% vs 2.4%), and dizziness (0% vs 1.6%) in the gammaCore and sham arm, respectively. Most adverse events were mild and transient and occurred primarily during administration.
Clinically proven as a safe and effective preventive treatment of cluster headache7,10,11
A prospective, open-label, randomized study that compared the use of gammaCore plus standard of care (SoC) vs SoC alone.
In the PREVA study, the addition of gammaCore (nVNS) provided a statistically significant reduction in the number of cluster headache attacks per week (primary endpoint).
gammaCore provided patients with:
Significant reduction in the number of cluster headache attacks per week
- Attack frequency at the end of the randomized phase decreased by 40% from baseline with SoC + gammaCore and increased by 1% with SoC alone (P<0.001)
Significant reduction in the use of acute pain treatments
- During the randomized phase, the SoC + gammaCore group had a 57% decrease in the frequency of acute medication use (P<0.001)
In PREVA, 7 patients discontinued due to adverse events (AEs). Similar proportions of participants in both SoC + gammaCore and control groups reported ≥1 AE. Most AEs were mild or moderate. The most common AEs in any treatment group were cluster headache attacks, headache, nasopharyngitis, dizziness, oropharyngeal pain, and neck pain. No serious AEs were considered gammaCore related.
Clinically proven as a safe and effective treatment for episodic cluster headache7,12,13
Pooled analysis of 2 double-blind, randomized, sham-controlled trials evaluated the efficacy, safety, and tolerability of gammaCore (nVNS) in 252 patients with cluster headache.
While these studies included patients with chronic cluster headache, gammaCore is indicated for the acute treatment of pain associated with episodic cluster headache (eCH).
gammaCore provided patients with:
Fast relief from the first attack
- 3x as many eCH patients treated with gammaCore reported mild or no pain at 15 minutes during their first treated attack vs sham (38.5% [n=52] vs 11.7% [n=60], P<0.01)
Reliable relief across multiple attacks
- For patients with eCH, gammaCore provided pain freedom at 15 minutes 3x more often than sham (24.1% [n=259] vs 7.3% [n=287], P<0.01)
Reduction in the duration and intensity of attacks
- 42.3% of eCH patients (n=52) treated with gammaCore reported mild or no pain in ≥50% of attacks vs 15% treated with sham (n=60) (P<0.01)
In ACT1 and ACT2, the most common adverse device-related events ≥5% were dysgeusia (0% vs 6.2%), erythema at treatment site (0% vs 7%), and perioral myokymia during treatment (6.5% vs 0%) in the gammaCore and sham arm, respectively. Most adverse events were mild and transient and occurred primarily during administration.
Migraine headache prevention treatment steps
To prevent migraines, patient should give themselves 3 treatments (morning, mid-day, and night) consistent of two consecutive 2-minute stimulations.
Daily:
Give yourself 3 treatments (morning, mid-day, and night) consisting of two consecutive 2-minute stimulations.
- The first daily treatment should be applied within 1 hour of waking. The second daily treatment should be applied 4-6 hours after the first treatment.
The third daily treatment should be applied at night. - Apply conductive gel before each stimulation. After 2 minutes, gammaCore will beep twice and automatically discontinue stimulation.
- Stimulations during a treatment should be applied on the same side of the neck. Additional treatments may be applied to either side of the neck.
Migraine headache treatment steps
When a migraine strikes, patients can administer up to 3 treatments consisting of 2 two-minute stimulations.
At the earliest sign of pain:
Give yourself a treatment consisting of 2 two-minute gammaCore (nVNS) stimulations.
- Apply the conductive gel before each stimulation. After 2 minutes, gammaCore will beep twice and automatically turn off.
The device should remain off for 10 seconds after each stimulation - Stimulations can be administered on the same side of the neck, or you can switch sides, if preferred
- If pain remains 20 minutes after the start of treatment 1, apply 2 more stimulations
- Two more stimulations may be applied if pain remains 2 hours after the start of treatment 1
Cluster headache prevention treatment steps
To prevent cluster headaches, patients should give themselves a treatment consisting of 3 two-minute stimulations twice a day.
Daily:
Patients should give themselves 2 treatments (morning and night) consisting of 3 two-minute gammaCore stimulations.
- Apply the conductive gel before each stimulation. After 2 minutes, gammaCore will beep twice and automatically discontinue stimulation
- Stimulations can be administered on the same side of the neck, or patients can switch sides, if preferred
Episodic cluster headache treatment steps
When an episodic cluster headache strikes, patients can administer a treatment consisting of 3 two-minute stimulations.
At the earliest sign of pain:
Patients should give themselves a treatment consisting of 3 two-minute gammaCore stimulations
- Apply the conductive gel before each stimulation. After 2 minutes, gammaCore will beep twice and automatically discontinue stimulation
- Stimulations can be administered on the same side of the neck, or patients can switch sides, if preferred
- After completing the 3rd stimulation, patients should wait 3 minutes. If pain remains, apply 3 more two-minute stimulations
- Patients may treat up to 4 attacks (or 8 treatments) for a total of 24 stimulations per day
A demonstrated safe and well-tolerated treatment7,8
Clinical trials have demonstrated the safety of gammaCore (nVNS).
- No serious side effects occurred with gammaCore
- Most gammaCore side effects
-
- — Are mild
- — Occur during use of the device
- — Go away quickly after each treatment
The most common side effects include discomfort and redness at the application site as well as dizziness. A tingling feeling where the device is applied is normal, but it should not cause major discomfort.
References: 1. Diener HC, Goadsby PJ, Ashina M, et al. Non-invasive vagus nerve stimulation (nVNS) for the preventive treatment of episodic migraine: the multicenter, double-blind, randomized, sham-controlled PREMIUM trial. Cephalalgia.2019;39(12):1475–1487. 2. Silberstein SD, Calhoun AH, Lipton RB, et al. Chronic migraine headache prevention with noninvasive vagus nerve stimulation: the EVENT study. Neurology. 2016;87(5):529-538. 3. Frangos E, Komisaruk BR. Access to vagal projections via cutaneous electrical stimulation of the neck: fMRI evidence in healthy humans. Brain Stimul. 2016;10(1):19-27. 4. Oshinsky ML, Murphy AL, Hekierski H Jr, Cooper M, Simon BJ. Noninvasive vagus nerve stimulation as treatment for trigeminal allodynia. Pain. 2014;155(5):1037-1042. 5. Chen SP, Ay I, de Morais AL, et al. Vagus nerve stimulation inhibits cortical spreading depression. Pain. 2016;157(4):797-805. 6. Akerman S, Simon B, Romero-Reyes M. Vagus nerve stimulation suppresses acute noxious activation of trigeminocervical neurons in animal models of primary headache. Neurobiol Dis. 2017;102:96-104. 7. gammaCore Instructions for Use. Basking Ridge, NJ: electroCore, Inc.; 2020. 8. Data on file, electroCore, Inc. 9. Tassorelli C, Grazzi L, de Tommaso M, et al. Noninvasive vagus nerve stimulation as acute therapy for migraine: the randomized PRESTO study. Neurology. 2018;91(4):e364-e373. 10. 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. 11. Gaul C, Magis D, Leibler 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. 12. 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. 13. 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.
