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There are 5 headache devices approved to treat acute migraine, 2 are also proven for prevention.
These are the only FDA approved devices for migraine prevention in the United States. I do not recommend buying imitatios.
Cefaly™
Cefaly is the only over the counter electronic device approved for migraine headache. It is approved both for acute migraine treatment and for migraine prevention. The design on the studies make it impossible to compare to the other migraine devices. What one can say is that for the on going cost of $1-2/day, it is the cheapest of the electronic devices to use on an ongoing basis. It works by stimulating some of the branches of the trigeminal nerve and therefore is worn on the forehead. How this then treats and prevents migraine is not clearly known. For acute treatment, the device is used for 60 minutes. For prevention, it is used 20 minutes each night. It is the only one available without a prescription.
Nerivio™
The Nerivio device is FDA approved for both acute migraine and migraine prevention. It is listed second as it is the cheapest of the FDA approved devices. The device is purchased and each device has 18 doses. The cost to the patient is less than $5/dose. For those with infrequent migraine that only need acute treatment, this is the cheapest option. Each treatment lasts 45 minutes. The device is worn on the arm and the patient is not as restricted from activity as the Cefaly device. A blinded study was used to prove the device works for migraine prevention. For prevention, it is used every other day for 45 minutes. Dr. Loftus teaches his patients to do prevention at night. It is done on odd days (easier to remember than every other day) when it is not needed during the day.
Relivion™
Relivion is a leased device. It has stimulating electrodes both in the front and in the back. In the front, it stimulates the same portion of the trigeminal nerve that the Cefaly device uses. In the back, it stimulates the occipital nerve. Treatments last up to one hour. An open label preventative trial is planned. It is the cheapest of the leased devices.
Gammacore Sapphire™
Gammacore Sapphire is a leased device. It works by stimulating the vagal nerve. Because it stimulates it without putting an electrode into the body, it is also known as nVNS (non-invasive vagal nerve stimulator). Of all of the headache devices on the market, it has the most controlled data. It is FDA approved for acute treatment of migraine, prevention of migraine headache, acute cluster headache treatment, and prevention of episodic cluster headache. Patient reviews has suggested it helps to prevent headaches in patients with hemicranial continua and paroxysmal hemicrania. To treat an active headache, the device is used for 5 minutes twice, 15 minutes apart. This relatively short treatment time allows the device to be used in circumstances when patients would other wise choose to wait before treating with one of the prior devices.
Acute therapy approval was based upon a double blind, sham controlled trial called the Presto Trial. The term double blind means the participants of the trial and those gathering the data did not know whether they were using a device that was the real device or a very clever sham device. The sham device worked more like a regular tens unit and caused local discomfort at the site. The treatment was one stimulation cycle on each side, wait 15 minutes and repeat. At 2 hours, after data was collected, another stimulation cycle on each side could be repeated. Pain free (1st use) for active treatment vs sham was 12.7% vs 4.2% at 30 minutes, 21% vs 10% at 60 minutes, 34% vs 19.7% at 2 hours. 50% responder rates (pain mild or pain free for more than 50% of headaches treated) was 47.6% vs 32.3% at 2 hours.
Savi Dual™
Savi Dual (formerly known as Spring TMS or sTMS) is the most expensive of the leased devices. It is the easiest of all of the devices to use. It delivers a single transcranial magnetic stimulus (sTMS) to the back of the head by simply pressing a button. 4 stimulations twice daily is used for prevention. 4 stimulations is used for acute treatment. It has the least discomfort of all of the devices. Despite being the easiest system to blind, it has only been demonstrated to work in double controlled placebo controlled trial for acute migraine with aura. This trial was for migraine with aura. There is open label data to suggest it can work for migraine without aura and for migraine prevention. Given the high cost, Dr. Loftus only recommends it for those with mostly migraine with aura or those that have failed other devices and have not other available options.
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Deanna Y.(Patient Since 2011)
If you have chronic migraines this is the doctor to see. Have been going there for 8 yrs. I drive 80 miles round trip to see him. I have seen many, many neurologists over the years and he is the best. He takes time to listen to you and he gives you typed copy of his instructions.
Tabitha H.(Patient Since 2017)
I have suffered with migraines since 2012. Not just any migraines severe, debilitating migraines . I would be bedridden for days, weeks and at one point even months. I have been to doctors all over Louisiana and Texas since the end of 2012. I finally started going to a neuro-ophthalmologist in the Houston area in either 2015 or 16. ( Dr. Rosa Tang ) She was treating me for another health problem that I have been suffering with since 2012 as well. When I gave her my medical history I told her about my migraines. They would be so severe at times that I would get migraines in my eyes and it would feel like someone was stabbing me with a knife in my eyes. I would also get extremely nauseated and have even thrown up on several occasions due to the severity of my migraines. Dr. Tang referred me to Dr. Loftus sometime around the beginning of 2017. Honestly, I thought why? I’ve been to all these other doctors and had very little hope that he would be able to help me. I met with Dr. Loftus and he was very thorough. He stayed in the room with me asking questions for at least 20 minutes. He started me on a new medicine and did treatment on me that day. From that day forward my migraines have gotten so much better. I’m slowly getting my life back. We have had to adjust my medicine a couple of times. But I can tell a huge difference since I began going there. Yes, I still do get migraines however, they are nowhere near as severe as they used to be. I can function so much better now since Dr Loftus has been training me. He doesn’t just throw his hands up in the air and say I don’t know how to help you, he keeps trying new things until he finds a solution. He is phenomenal, his staff is great and I’m so thankful that God made a way and lead me to his office. I highly, highly recommend him if anyone out there has had their life stolen from them by migraines.
Providing headache and hyperhidrosis care & wellness for over 25 years.
Dr. Brian Loftus, M.D.
Dr. Loftus is Board Certified in Headache Medicine as well as Neurology. In private practice since 1994, Dr. Loftus’ practice has gotten busier and he has decided to concentrate his practice in areas that he can make a particular difference compared to other neurologist. Therefore, Dr. Loftus has chosen to focus his neurology practice on headaches & head pain, headaches during pregnancy, and hyperhidrosis. In the spring of 2006, Dr. Loftus relocated his practice from the Texas Medical Center to Bellaire, just 5 miles west. He has been named a Texas Monthly “Super Doctor” and an H Texas magazine “Top Doctor” multiple times.