Migraine Treatment Devices

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.