Timothy C. Hain, MD, Chicago IL. • Page last modified: June 2, 2021
Here we are going to comment on a set of devices proposed for migraine. Our perspective on this is basically -- be skeptical. Most if not all of these are either placebos or are just unreasonable. Or as they say, caveat emptor.
There are numerous studies (see reference list for a few) that report improvement of migraine with transcutaneous stimulation.
The most recent device, Cefaly -- is a TENS unit recently FDA approved for migraine (2014). It stimulates the supraorbital nerve. There are many reports of migraine getting better from nerve stimulation (e.g. occipital nerve, sphenopalatine nerve, auricular nerve) as well as benefitting from nerve blocks (Magis, 2015; Ashkenazi and Young, 2005) and even infrared lasers -- i.e. heat (Allias et al, 2003). Puzzling, eh ? This may be a lot of wishful thinking (Ambrosini and Schoenen, 2016). After all, we are dealing with a subjective disorder. Placebos work better if they involve devices.
There are also other bizzare devices (see below), involving shocking other parts of one's anatomy.
The illustration on the left is from the Cefaly web site. The double blind placebo controlled study in Belgium reported that it reduced the mean # of headache days. The therapeutic gain reported was 26%. This puts this device into the "mildly effective" category, as compared to migraine medications such as venlafaxine, verapamil, or topiramate which generally are effective in about half or more. We have had only a few patients benefit from this device, although we have treated many 1000's of migraine patients.
The Cefaly device can be obtained with a prescription for $295. As a general rule, health insurance is slow to pay for "durable medical devices", such as this one. In other words, this is a $295"out of pocket" expense.
The principal of the Cefaly device is stimulation of the supraorbital nerves. But why would someone want to do this ? If your head is hurting, why shock it with more electricity ?
There are cheaper TENS units that are not as "cool" looking that can be adapted for the same purpose, and rented rather than purchased. This cuts the "out of pocket" cost down immensely. We think this is a logical way to proceed when trying out this treatment, but we don't see any reason for someone to try this in any case.
As a general comment, it is hard to see how shocking someone, anywhere on their body, would be likely to reduce their headache. Create a headache -- sure. I suppose one might argue that acupuncture reduces pain - -but these things don't seem to be acupuncture.
Regarding the numerous other devices have been suggested - -these all go under the general category of "Neuromodulation". Some of them use magnetic pulses instead of electrical pulses. All of these seem to us to be placebos. As PT Barnum supposedly said: there's a "sucker born every minute". Harsh perhaps ? Well anyway, lets look at a few of these. We are paraphrasing from the Tepper/Tepper article from 2018.
- The "Spring" TMS device was approved in July of 2017. This is a device intended to modify cortical excitability using magnetic pulses. Patients "rent" the device with a monthly fee. While hope "springs" eternal, this sounds like another placebo to us.
- Vagal nerve stimulation (nVNS, gammacore), mainly failed to show an effect. However, as there seems to be low risk, this device was approved in 2017. This device again is basically rented. Again, sounds to us like a placebo. Another study of nVNS was recently published (Tassorelli et al, 2019). This study was funded by electroCore, the vendors of the gammacore device. We would be more sympathetic if a study was done with funding outside the industry that benefits from the study.
- Caloric vestibular stimulation (Scion). This is an unusual hypothesis as well as device involving stimulating the vestibular nerve. We find it very hard to understand how this could do anyone any good -- sounds like a placebo. Interestingly enough, rotatory chair (ie. spinning around) increases migraine (Murdin et al, 2009).
- Upper arm stimulation (Nervio Migra). We find this one hard to understand. Shocking your arm, to control head pain.
- Occipital/supraorbital nerve stimulation (OS-TNS, Relivon). We find it hard to follow that shocking someone over a nerve in their head could relieve their migraine.
- Occipital nerve stimulation with an implanted wire. This one does not seem to work. In 2014 the EU rescinded approval of the St. Jude device.
- Deep Brain Stimulation. An electrode is implanted in the hypothalamus. We see this as far too invasive. Even opiates seem safer than this.