Just about everyone who lives with or works in a field related to migraine disease acknowledges that patients need better options for migraine prevention that carry fewer side effects. With this idea in mind, researchers in Belgium recently examined the effectiveness of supraorbital transcutaneous stimulation (STS) for migraine prevention.
In supraorbital transcutaneous stimulation, a stimulator device is placed on the patient’s forehead and an electrical current is applied to the supraorbital nerves. The supraorbital nerves are a branch of the frontal nerve. This branch passes through a bony area above the eye socket and just below the eyebrow known as the supraorbital foramen and extends to the forehead and scalp. Although peripheral nerve stimulators are well accepted as a treatment for some chronic pain conditions, such as spinal cord stimulation (SCS) for back pain, their application for headache disorders like migraine disease has not been adequately studied.
Peripheral nerve stimulation devices like STS, SCS and occipital nerve stimulators (ONS) work by utilizing neuromodulation. Neuromodulation involves targeting the abnormal pain signals sent out by the nerves with electrical impulses that interrupt their pain messages.
The researchers recruited 67 migraine patients from five different headache clinics in Belgium. All study participants were between the ages of 18 and 65, had been diagnosed with migraine with aura or migraine without aura according to the ICHD-II criteria (the gold standard) and had at least two migraine attacks a month. Patients were excluded if they’d used a preventive therapy within the past three months, failed three or more migraine preventive medications or been diagnosed with medication overuse headache, chronic tension-type headache or certain severe psychiatric disorders.
All patients were observed with no treatment for the first month, then given three months of either sham treatment or 20 minutes of STS treatment daily. By month three, patients receiving the STS treatment experienced nearly 30% fewer migraine attacks per month. At month three the placebo group not receiving the real STS treatment experienced a 4.9% increase in number of attacks. The treatment group also used fewer acute migraine treatment medications (nearly 37% less), while the placebo group used more (.46% more). Notably, there was no improvement in severity of remaining migraine days among patients who experienced a reduction in number of days.
Although previous research studies on nerve stimulation for migraine prevention have established that a combination of supraorbital and occipital nerve stimulation is most effective, placement of an occipital nerve stimulator can be an extremely invasive procedure. Typically patients first undergo a trial surgery involving implantation of an ONS device and battery pack, then a second surgery for permanent placement if the trial is successful. By contrast, STS is noninvasive.
Two final notes: First, the subjects studied here were not the most debilitated migraineurs, as is easily deduced by examining the inclusion and exclusion criteria discussed above. It remains to be seen how STS alone might work in treatment-resistant chronic migraine patients.
Second, it’s incredibly difficult for researchers to design a truly double blind experiment when studying peripheral nerve stimulation. It’s simply too easy for patients to notice whether any electrical current is coming through the device, especially if they happen to touch the electrodes with their fingers. An editorial accompanying the study suggests adding an additional group to these studies that receives electrical stimulation that isn’t applied to the nerves in question to address this concern.
Although this study doesn’t apply to the group probably most in need of peripheral nerve stimulation as an option (those with chronic and/or intractable migraine), hopefully the research can be a building block to developing solutions for that group.
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1. Jean Schoenen, MD, PhD; Bart Vandersmissen, MD; Sandrine Jeangette, MD; Luc Herroelen, MD; Michel Vandenheed, MD; Pascale Gérard, Phy; and Delphine Magis, MD, PhD, ” Migraine prevention with a supraorbital transcutaneous stimulator: A randomized controlled trial,” Neurology, Published online before print, Feb. 6, 2013, http://www.neurology.org/content/early/2013/02/06/WNL.0b013e3182825055.abstract, accessed Feb. 5, 2013. 2. Eishi Asano, MD, PhD, MS; and Peter J. Goadsby, MD, PhD; “How do we fashion better trials for neurostimulator studies in migraine?” Neurology, Published online before print, Feb. 6, 2013, http://www.neurology.org/content/early/2013/02/06/WNL.0b013e3182825174.excerpt, accessed Feb. 5, 2013. 3. North American Neuromodulation Society, “About Neuromodulation,” http://www.neuromodulation.org/About-Neuromodulation/About-Neuromodulation/aboutneuromodulation.html, accessed Feb. 5, 2013. 5. Bartleby.com, Gray’s Anatomy of the Human Body: Trigeminal Nerves, http://www.bartleby.com/107/200.html, accessed Feb. 5, 2013.