A new study of Cefaly to treat acute migraines

Cefaly is a transcutaneous electrical nerve stimulation (TENS) device designed to treat migraine headaches by stimulating supraorbital nerves. The device was cleared by the FDA in 2014 for both acute and preventive treatment of migraine headaches. The preventive indication was based on a double-blind trial involving only 67 patients, while the use of Cefaly for acute migraines was based only on an open-label trial. A study recently published in Cephalalgia examined the efficacy of this device for acute treatment of migraines in a double-blind trial of 106 patients.

The trial confirmed that Cefaly is indeed effective for abortive therapy of migraine attacks. For prevention, it is recommended to use the device for 20 minutes every day, while to treat an acute attack the device should be used for an hour. The primary outcome measure was the mean change in pain intensity at 1 hour compared to baseline. This primary outcome measure was significantly more reduced in the stimulation group compared to the sham group: 60% versus 30% reduction. No serious adverse events were reported and five minor adverse events occurred in the stimulation group. I’ve had one or two patients report that the device actually triggered a migraine, but this can also happen with any oral migraine drug.

The main reason I offer Cefaly before any other device (eNeura TMS or gammaCore) is that it is the most affordable. The price has gone up since it’s introduction and ranges from $350 to $500, however the manufacturer offers a 60-day return policy. This is long enough to see if it is effective. Cefaly is sold only with a doctor’s prescription, which is uploaded to the Cefaly website (Cefaly.us for US patients and Cefaly.com for the rest of the world).

6 comments
  1. Dr. Mauskop says: 04/06/20199:53 am

    I would recommend ginger capsules with 550 mg, which is a common strength. I like products from Nature’s Way and Puritan Pride. They have good quality and low prices. Ginger tea probably does not have enough of the active ingredients, but can be a good way to relieve nausea of migraines.

  2. James Harless says: 04/05/201910:20 pm

    As one reads the blog, as a person residing in Tennessee I see this blog as a national resource for many outside NY. Given the optimism expressed about use of ginger as helping those with migraine, is one form or method to use ginger best? Or given some optimism might one try ginger powder in specific ways, and then some ginger tea other times, or ginger supplements of given description? Perhaps use separate weeks in part, or even all at one time for two, three or more forms of ginger? Jim.

  3. Dr. Mauskop says: 03/19/201910:41 pm

    Yes, it is possible that eating too much dairy foods and taking calcium supplements may interfere with the absorption of magnesium.

  4. James Harless says: 03/19/20194:54 pm

    I read article from one weight loss doctor who has written an article 10 reasons to supplement magnesium, and within the comments we find a comment that too much calcium going into cells may cause problems like migraine or other health impacts. If a relative too much calcium can cause such multiple issues, can a person with chronic migraine consume too much milk, cheese, or dairy foods, or should also not take supplemental calcium? Thanks for home site & blog. Jim.

  5. Dr. Mauskop says: 03/16/20195:29 pm

    Cefaly is only modestly effective, although it could be because we tend to treat more severely affected patients. As far as which model to use, it depends on the frequency of attack. If migraines are frequent, dual makes sense, but if they are not, I would buy the cheaper model.

  6. Bill Kilcoyne says: 03/16/20194:30 pm

    How effective has this been for your patient population. Would you recommend the dual mode or the prevent or acute. As the dual mode is 500 vs 350$. It’s always concerning when the trial is based on so few patients.

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