LONDON – Enthusiasm is mounting among headache specialists for noninvasive device therapy for acute migraine.
"Normally I’m quite a cynical person, but I think within 10 years time half of my people in the headache clinic won’t be using any medications for their headaches. They’ll have an electronic device of some kind. You get your migraine sorted out, you put your device back in your pants pocket, and you carry on," Dr. Fayyaz Ahmed said at the European Headache and Migraine Trust International Congress.
The Spring TMS device [shown here] is manufactured by U.S.-based eNeura Therapeutics, which is seeking marketing approval from the Food and Drug Administration.
"I think in about 10 years time you’ll have SIM cards for these neurostimulatory devices, you’ll put the card in an ATM-like machine – perhaps in a supermarket – and you’ll top it up and recharge it," predicted Dr. Ahmed, a consultant neurologist in Hull, England, and chair of the British Association for the Study of Headache.
The noninvasive neurostimulatory therapy most discussed at the congress was the Spring TMS single-pulse transcranial magnetic stimulation device, which since 2011 has been approved in Europe for the acute treatment of migraine. The Spring TMS device is manufactured by U.S.-based eNeura Therapeutics, which is seeking marketing approval from the Food and Drug Administration.
The international congress also saw the presentation of the first multicenter, randomized, sham-controlled study of the noninvasive Cefaly device for prevention of migraine via supraorbital transcutaneous neurostimulation.
"It’s not a revolutionary therapy. The effect size is moderate and inferior to that of the most effective preventive drugs. Its great advantage is that it’s devoid of side effects. I think the Cefaly device is another tool we can use for preventing migraine," Dr. Jean Schoenen concluded in presenting the study data.
Dr. Ahmed said physician and patient interest in noninvasive device therapy is being driven by the sizable proportion of migraine patients who don’t respond adequately to drug therapy, can’t tolerate it, or have contraindications to its use. Plus, some patients would just rather be drug free.
Neurostimulatory therapy for headache has followed an evolutionary process, progressing from highly invasive to minimally invasive and now to noninvasive devices, the neurologist observed.
The noninvasive neurostimulatory therapy most discussed at the congress was the Spring TMS single-pulse transcranial magnetic stimulation device, which since 2011 has been approved in Europe for the acute treatment of migraine.
First came deep brain stimulation of the subthalamic nucleus via implanted electrodes, which proved useful in treating Parkinson’s disease.
In the field of headache, there are 14 published studies of deep brain stimulation of the ventroposterior hypothalamus for treatment of intractable chronic cluster headache in a collective total of 64 patients. Two-thirds responded with at least a 50% decrease in pain. But this highly invasive form of therapy is not effective as acute therapy, only for prevention, and it entails a 3% rate of intracranial bleeding.
Next came minimally invasive systems for occipital nerve stimulation. Response rates have been variable in 10 published studies totaling roughly 500 patients treated for chronic migraine. In addition, the devices are quite expensive and are susceptible to lead migration or breakage and battery depletion.
"Only a couple of centers in the U.K. are doing occipital nerve stimulation now," according to Dr. Ahmed.
Yet there is still commercial interest in developing minimally invasive neurostimulatory therapy for headache. During the London headache congress, St. Jude Medical announced that its Eon family of neurostimulators had just received European regulatory approval for treatment of intractable chronic migraine. Among the newly approved devices is the Eon Mini, which weighs about an ounce and has a 10-mm profile.
The recently published 12-week, double-blind, multicenter pivotal study sponsored by St. Jude Medical involved 157 patients with chronic migraine randomized 2:1 to peripheral nerve stimulation or sham control. Of patients on active therapy, 35% achieved at least a 30% reduction in pain, a rate more than twice that in controls. The active treatment group also had a mean 6.1-day reduction in headache days per month from a baseline of 22 days, compared with a 3-day reduction in controls (Cephalalgia 2012 Oct. 3 [doi: 10.1177/0333102412462642]).
A company spokesperson said St. Jude Medical definitely plans to seek U.S. marketing approval for its Eon neurostimulators.
The best-studied noninvasive neurostimulatory device therapy for migraine is the single-pulse transcranial magnetic stimulation Spring TMS device. It delivers a complete treatment in less than a minute at the first sign of migraine pain and has a side effect profile similar to that of sham therapy in clinical trials, according to Dr. Kevin G. Shields, a neurologist at the National Hospital for Neurology and Neurosurgery in London.