The first randomized controlled with a device that stimulates the trigeminal nerve in the head has shown a moderate effect in the prevention of migraine.
The device (Cefaly, STX-Med, Herstal, Belgium) is worn like a headband and stimulates the nerve through the skin. In the study, using the device for 20 minutes each day was associated with a 25% reduction in migraine days from baseline and a 19% reduction in migraine attacks.
"As the first randomized trial of this device, this is the first real evidence that it works," lead investigator Jean Schoenen, MD, PhD, from Liège University, Belgium, commented to Medscape Medical News. "It is not a revolution but it is a worthwhile addition to the current armamentarium. It is an interesting treatment for some patients but not all. A major advantage is that, unlike most drug therapies, it does not have side effects."
The current study, known as the PREvention of MIgraine using the STS Cefaly (PREMICE) trial, is published online February 6 in Neurology.
The Cefaly device is already available in Europe, as well as several South American and Middle Eastern countries and Canada. It is awaiting approval in the United States and China. It does need a prescription and can be bought directly by the patient at a cost of €295.
For the study, 67 patients with at least 2 migraine attacks per month underwent a 1-month run-in period and were then randomly assigned to the Cefaly device or sham stimulation (which produced a tingling sensation but did not effectively stimulate the trigeminal nerve) for 20 minutes each day for 3 months.
Patients in the active device group showed a reduction in the number of migraine days per month, migraine attacks, and intake of acute migraine drugs compared with the control group.
The 50% responder rate (the percentage of patients in whom migraine days were reduced by 50% or more) and the 25% responder rate (the percentage of patients in whom migraine days were reduced by 25% or more) were also higher in the active treatment group.
Table. PREMICE: Major Results
|Endpoint||Active Treatment||Sham Control||P Value|
|Change in number of migraine days from run-in to month 3||-2.06||0.32||.054|
|50% responder rate (%)||38.2||12.12||.023|
|25% responder rate (%)||58.8||27.3||.14|
|Change in migraine attacks from run-in to month 3||-0.82||-0.15||.044|
|Change in acute migraine drugs needed from run-in to month 3||-4.2||0.04||.0072|
No adverse effects were reported in either group.
Dr. Schoenen noted that many drug treatments for migraine prevention are available, which vary in effectiveness in different individuals.
"I would say they are effective about half the time," he said. "Clearly there is a need for more therapies. This is just one that might be useful especially for people who feel uncomfortable taking drugs every day." He added that it could also be combined with drugs with the possibility of added effectiveness.
In their discussion, the researchers compared the effectiveness of trigeminal nerve stimulation with that of topiramate, which they say is one of the more effective migraine prophylactic drugs.
Although this was not a head-to-head trial, they point out that topiramate has a 50% responder rate of about 45%, compared with 38% for Cefaly in the current study. Dr. Schoenen notes that around a quarter of patients stop taking topiramate because of adverse effects, whereas "this should not be such a problem with the device."
Adherence May Be an Issue
But adherence is still likely to be an issue with the device. In the current study, adherence was only around 60%, which is lower than that reported for migraine prophylactic drugs, probably because of the time taken to use the device.
"It is obviously more time-consuming than taking a pill," Dr. Schoenen commented. "But it is actually quite user friendly. It can be worn when the patient is getting on with other things like working at the computer or making dinner. It is best if people can build it into their routine and put it on for 20 minutes every day at the same time, for example when making breakfast or before they go to sleep at night."
. He said that using the device is not painful, "but the patient will feel the electrical stimulation, which grows in intensity gradually. It is possible to stop the increase in intensity by just pushing a button."
Dr. Schoenen added that the time of 20-minute use each day chosen was totally empirical. "We considered what may be effective and what would be considered convenient for adherence to treatment. More time might produce better results, but it might also result in lower compliance. Twenty minutes was a compromise."
He noted that the device has been quite popular in patients in his clinic. "We have a database of more than 2000 patients who have had the device. They can borrow it for 2 months from the company to try and if they like it they can then buy it. In our database, 46% of patients decided to go ahead and buy it. This is similar to our study results."
It is not well understood exactly how the device works. Although peripheral nerve stimulation is an accepted treatment for chronic pain, it is poorly studied in headaches. It is believed that stimulation of peripheral nerves around the head may reduce headache.
The researchers note that migraine pain is mediated through the trigeminal nerve, and it is thought that stimulation of this nerve might change activity in supraspinal centers belonging to the pain matrix or the migraine matrix, increasing the migraine threshold.
Previous studies have also suggested that stimulation of the occipital nerve can reduce headaches, and Dr. Schoenen and colleagues are now testing a new device that stimulates both the occipital and trigeminal nerves.
In an accompanying editorial, Eishi Asano, MD, PhD, MS, and Peter J. Goadsby, MD, PhD, point out that the PREMICE study has provided class III evidence that neurostimulation with this device is effective and safe as a preventive therapy for migraine.
They say that the evidence cannot be considered stronger than this because the effect size was small and that unblinding might have been an issue given that there would have been a large difference in perceived intensity between the active and sham treatments.
However, they conclude that, "New therapies are needed in migraine, and further studies of neurostimulation using innovative study designs are warranted to explore the optimum way to create an acceptable evidence base for widespread use of this potentially valuable treatment modality."
This was an investigator-initiated trial funded by the Walloon Region. STX-Med provided the devices. None of the investigators has any financial interest in STX-Med.
Neurology. 2013;80:697-704, 694-694. Published online February 6, 2013. Abstract
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Cite this: Neurostimulation Effective in Migraine Prevention - Medscape - Feb 06, 2013.