Non-invasive Vagus Nerve Stimulator Approved to Treat Migraine Pain

On January 29, 2018, the FDA approved gammaCORE, a hand-held, non-invasive, vagus nerve stimulator (nVNS) for the treatment of migraine pain in adults. The device was first approved in April 2017 for the treatment of episodic cluster headache pain in adults.

Results from the PRESTO study, a randomized, multicenter prospective study of nVNS for the acute treatment of migraine, were instrumental in the expanded indication. A total of 243 people with episodic migraine were included in the study; 123 received nVNS and 120 received sham (placebo) treatment. A significantly greater proportion of people receiving nVNS were pain free at 30 minutes (12.7%) versus those receiving sham treatment (4.2%; P=0.01) and at 60 minutes (21% versus 10% respectively; P=0.02). Between-group differences at 120 minutes missed statistical significance, (30.4% nVNS vs 19.7% sham; P=0.07), but a post-hoc repeated-measures test was performed to examine inconsistency between the 120-minute findings and the 30- and 60-minute findings and did show significance.

The manufacturer, electroCORE LLC, reports that the device will be commercially available for the treatment of migraine pain in adults in the second quarter of 2018. It’s important to note that the safety and efficacy of gammaCORE have not been been confirmed for the acute treatment of chronic cluster headache or for preventative treatment of chronic or episodic cluster headache or migraine. The device also is not indicated for use in children, pregnant women, people with active implantable medical devices, people with conditions like carotid atherosclerosis, hypertension, or bradycardia/tachycardia, or people with a metallic device near the neck. The gammaCORE device also should not be used at the same time that a person is using his or her mobile phone or other portable electronic device.

Comments

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  • voiceofjoyce
    8 months ago

    I have only been using this device for 3 weeks and already have seen huge improvements. I highly recommend talking to your neurologist and trying it out. I don’t know how long the company will be offering a free first month. I am excited that ttndiva mentioned a possible rechargeable one since the current ones not only shuts off after 31 days, but then you have to throw it away and buy a new one – even if you haven’t used all the charges? Arden is right, it’s unethical. Anyone know a good pro-bono lawyer? I wish everyone the best. My experience is that if this doesn’t help, don’t give up.

  • ttndiva
    9 months ago

    I had this device when it was in trial and my husband thinks this particular treatment has worked est for me above any other. I was able to reduce my migraines from chronic to episodic and it was a simple device that I used two to three times a day. There’s supposed to be a rechargeable option coming out in June.

  • voiceofjoyce
    8 months ago

    ttndiva~It’s wonderful to hear you have had such good response. I have been using mine for only 3 weeks, but I know it is making a huge difference, too. You mention a possible rechargeable option soon. Dare we hope? And have you heard about insurance involvement?
    Here’s hoping.

  • arden
    11 months ago

    Start saving your money for this thingy. Kerrie of Theraspecs reports it costs in USA $600 without insurance and needs to be replaced monthly!!!! That is simply outrageous and unethical.

  • voiceofjoyce
    8 months ago

    I completely agree. But after using it for three weeks and having an amazing outcome, I am getting on the bandwagon to force insurance companies to cover it. How do we show them we’d be saving them money in the long-run. Heck, a trip to the ER for some narcotics vs. a little device you can use at home must be worth something. Here’s hoping.

  • Tamara
    12 months ago

    This should be a good device for espisodic migraines. It’s not really might for for chronic migraines prevenation. I did feel it settleing down some of my migraine flares BUT 1) I need 10-15 minutes to use enough pulses and my can come on too fast for that 2) my chronic migraines are related very loose neck ligaments and thus any muscle tightness will worsen them. The gammacore would stop a migraine but it would come back the next day because of he muscle tightness. Tried different positions and tips from company but nothing worked for me. They do let you try the device for a month before you have to pay so why not try it?

  • mrst53
    11 months ago

    where can I sign up to try this? If I could cut down on 1 or 2 a month, it would be worth it.

  • voiceofjoyce
    8 months ago

    I got a device free of charge (first month only – but enough to tell if it helps) by getting a prescription through my neurologist. I have chronic migraine and it has been incredibly effective for me. I know everyone doesn’t have the same response, but I highly recomomend looking into it whole-heartedly. It is definitely a game changer for me. Good luck!

  • Dana
    12 months ago

    I was psyched when I saw it was approved for use, but the jury seems …eh…..

  • John1381
    12 months ago

    I had this device on a trial, it is easy to use and painless – unless your nephew resets the controls when you aren’t looking. It didn’t work for me with chronic migraine, but it may help others.

  • KSMc1984
    12 months ago

    I’m really curious about this product. My migraine doctor was less impressed when I told him about it.

  • mrst53
    11 months ago

    going to ask my neuro doc about this.

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