A common subject of questions about Migraine is that of the various neurostimulator devices that we keep "hearing" about. None of these devices have yet been approved by the FDA for use in treating Migraine, but Migraineurs want to know more about them.
Today, the results of a small study in Belgium were released in the journal Neurology. This is the PREMICE study: PREvention of MIgraine using the STS CEfaly. Some of you may have seen the Cefaly device discussed online, but most of the discussion has surrounded its use to stop a Migraine in progress as opposed to preventing Migraine.
As stated by the authors, the study objective was,
"to assess efficacy and safety of trigeminal neurostimulation with a supraorbital transcutaneous stimulator (Cefaly, STX-Med., Herstal, Belgium) in Migraine prevention."
- The study was double-blinded and sham controlled. This means that every patient thought they were using the stimulator as it would be used for treatment, but some were using devices that looked and felt functional, but were not. Neither the study participants nor the researchers knew which patients had the actual stimulators and which had the shame devices until after the trial was concluded.
- There were 67 patients enrolled in the study. Inclusion criteria:
- ages 16- to 65-years-old
- diagnosed with Migraine with aura or Migraine without aura
- at least two Migraine attacks per month
- An electronic system built into the device facilitated recording usage of the stimulators by the study participants for evaluation of complying with study guidelines.
- Of the initial 67 participants, 59 completed the study according to study protocol.
- Migraine days decreased by an average of 20% during the first month in both the active device and sham groups.
- During the second and third months, Migraine days were reduced by 29.7% in the active device group, but by only 4.9% in the sham group.
- There was no difference in results between participants with Migraine without aura and participants with Migraine with aura.
- The use of acute treatment medications decreased 36.64% in the active device group, but by a statistically insignificant amount of just 0.46% in the sham group.
- No adverse events or side effects were reported during the trial.
The study authors conclude:
"Supraorbital transcutaneous stimulation with the device used in this trial is effective and safe as a preventive therapy for migraine. The therapeutic gain (26%) is within the range of those reported for other preventive drug and nondrug antimigraine treatments."
Summary and comments:
Although the results appear to be excellent, this study was far too small to support the conclusion that the therapeutic gain with the Cefaly is within the range reported for other preventive therapies. With so small a study, this is a premature conclusion.
The Cefaly device is available without a prescription, and is easy to purchase online. They are not, however, inexpensive, selling for approximately $300. A valid point can be made that many patients must spend far more than that on medications, with medication costs often exceeding that $300 for just one month of medications. Still, $300 is a lot of money for most patients.