What’s the deal with the “Omega Procedure”?

The Omega Procedure is a trademarked surgical procedure for patients diagnosed with chronic migraine (15 or more attacks per month) that entails implanting an occipital nerve stimulator beneath the skin while the patient is under general anesthesia. It requires an initial minor surgery for a trial period, and second surgery for permanent implantation, and a battery pack change every 10 years. Removal or repair requires surgery as well.

According to the Migraine Treatment Centers of America (MTCA), the Omega Procedure is an “innovative surgical procedure that provides long-lasting relief for people who suffer from chronic, debilitating migraine pain.”¹

The patient testimonies on their site are certainly dramatic and compelling. One reads, “I am 100% migraine free since I woke up from surgery last year (2015) I never thought I’d ever be able to say that my entire life. Since surgery, I make plans weeks or days even ahead of time now, I work two jobs, finished my bachelor’s degree in criminal justice, was available to go to school as well full time to graduate, play with my two dogs, go on trips, got married, bought a house and was able to fix it up…mainly I get to LIVE the LIFE I never thought I’d get to. (I can now) Make it through a whole day without any medication or being in bed. I live life every day now without any interruptions.”

The site also makes claims such as: “Patients who respond to neurostimulation have experienced an 80% to 100% reduction in their migraine pain.”

Doesn’t that sound nice? But if this were truly the revolutionary, effective, and accessible answer we’ve been waiting for, then wouldn’t there have been a flurry of excitement amongst top migraine specialists, along with line ups out the door for millions of Americans to have thin wires and a battery implanted beneath their skin from forehead to lower back over the last decade? Why aren’t we all in that line??

The MTCA site references many studies, and while the conclusions sound promising, it is important to note that these studies are small, and some are not directly related to migraine at all.

According to an overview of recent data by Trentman and Schwedt, “There are a growing number of observational reports regarding invasive peripheral stimulation for headaches; however, little or no randomized, controlled data is available to guide clinicians, except ONS [occipital nerve stimulation] for refractory migraines.”² In other words, the only reliable data for this surgical implant pertains to migraines that are unresponsive to other kinds of treatments; according to science, this surgery should only be considered as a last resort.

Trentman and Schwedt go on to conclude that the three existing well-designed studies (larger, randomized, placebo-controlled) of occipital nerve stimulation provide "some evidence for modest benefits” for patients with refractory migraine. They also explain that the procedure is not FDA approved, and can cost patients over $50,000. Migraine Treatment Centers of America say they work with most secondary insurance companies, but the Omega Procedure is a no go for Medicare and Medicaid.

According to the American Headache Society, “Occipital nerve stimulation (ONS) has had limited success in the treatment of patients with migraine. Preliminary results in a small number of patients indicate that the addition of supraorbital stimulation (SONS) may improve results in patients with chronic migraine.”³

My conclusion: this is a procedure that is still in development, and needs further studies to determine its efficacy as well as the risk of potential unpleasant side effects. It does show exciting promise, and has been a game changer for many patients, but the cost is too prohibitive to be realistic for the masses. If I had a generous insurance plan or an extra $50,000 lying around and nothing else was working, I’d probably give it a go.

For more migraine.com reading on the topic of nerve stimulator implants for migraine, check out these 2013 articles:

Migraine Prevention News: Peripheral Supraorbital Transcutaneous 

Migraine and “the Box”: Feeling like Guinea Pig with an Occipital Nerve Stimulator

Nerve Stimulation Research

Nerve Stimulation: Questions to Ask

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