By Bob Marshall, Chief Editor, Med Device Online
In the U.S., more than 37 million people suffer from migraine headaches. Some migraine studies estimate that 13 percent of adults in the U.S. population have migraines, and 2-3 million migraine sufferers are chronic. Almost 5 million in the U.S. experience at least one migraine attack per month, while more than 11 million people blame migraines for causing moderate to severe disability, according to statistics from Health Union's Migraine.com web site.
But what exactly is a migraine? In the simplest of terms, it is a headache of varying intensity, often accompanied by nausea, as well as sensitivity to light and sound. But anyone who has had a migraine will tell you it comprises so much more than the external symptoms. Researchers now believe that migraine is a neurological disorder involving nerve pathways and brain chemicals. It is caused by the activation of a mechanism deep in the brain, leading to the release of pain-producing inflammatory substances around the head’s nerves and blood vessels.
Migraine is an incapacitating collection of neurological symptoms that usually includes a severe throbbing, recurring pain on one side of the head. However, in one-third of migraine attacks, both sides are affected. Attacks last between 4 and 72 hours, and often are accompanied by one or more of the following disabling symptoms: visual disturbances, nausea, vomiting, dizziness, and tingling or numbness in the extremities or face, as well as extreme sensitivity to sound, light, touch, and smells. Migraine sufferers usually can’t participate in normal activities because of the pain. Often when, a migraine strikes, people try to find a quiet, dark room.
Unfortunately, migraines’ impact is not limited to individuals’ pain and suffering; the pain also produces a financial impact. The World Health Organization’s disability rating for migraine ranks it as the 19th most common reason for disability. Migraine sufferers use twice the amount of prescription drugs, and visit doctors and emergency rooms twice as often, as those who don’t have the disorder. U.S. headache sufferers receive $1 billion worth of brain scans each year, according to the Migraine Research Foundation One study estimates the migraine-related loss of productivity in the U.S. to be between $5.6 billion to $17.2 billion per year, caused by missed work.
One of the medical technology companies working to meet the needs of migraine sufferers is privately-held eNeura, Inc. The company develops products for non-invasive, non-drug treatment and prevention of migraine headache. eNeura’s transcranial magnetic stimulation mini neuromodulation device (SpringTMS, or sTMS) is the only medical device currently approved in the United States for both the acute and prophylactic treatment of migraine headache. sTMS provides an alternative pathway to combinations of pharmaceutical products, each with potentially unpleasant side-effects, for both treatment and prevention of migraine.
I talked with David Rosen, president and CEO of eNeura, following the publication of a study in the peer-reviewed journal, Cephalalgia, demonstrating the company’s portable sTMS technology, administered daily, significantly reduces the frequency of migraine headache. The post-marketing study demonstrated that the four pulses emitted from SpringTMS, twice daily, resulted in 46 percent of patients experiencing at least a 50 percent reduction in migraine attacks per month while following the treatment protocol.
For certain patients, treatment options for migraines, such as oral medications, are not effective, well-tolerated, or preferred. Patients list sleepiness and fatigue, racing heartbeat, nausea, and difficulty thinking as common side effects of triptans — the most commonly prescribed class of drugs for recurring headache pain. The study produced clinically-significant results indicating SpringTMS may be an option for these patients.
Rosen pointed out a particularly interesting challenge that eNeura and similar technologies face in the healthcare market:
“We tend to think, if we induce an electrical current in the brain and something happens, that is beneficial; that’s somehow magic. But, when somebody has a heart attack and they’re in ventricular fibrillation, and they’re unconscious, and you defibrillate them with a huge electrical stimulation, we don’t think that’s magic. We just think that’s a defibrillator,” Rosen said. “Perhaps it’s because you get immediate feedback with the defibrillator. [But] the brain doesn’t work on that same loop… with our device, it takes some time.”
Rosen continued, “If people have been experiencing migraines for a long time, they’ve pretty much failed every other treatment before they get to us. But then, after using our device for a couple of months, some of these people don’t have headaches anymore. The therapy doesn’t work for everybody; we don’t know why that is, but it’s not risky to try it, and it could be life-changing. However, we know it won’t work overnight. The patient has had the disease for a long time, and it will take some time to work your way back to having a normally firing brain.”
Rosen is confident in his resolve that neurostimulation will continue to grow in popularity and achieve broader acceptance in the treatment of migraine. He sees future applications in treatment of depression, fibromyalgia, epilepsy, and maybe a lot of other diseases, as well.
“Today, we treat these diseases with drugs, because that is what we have available to us,” he explained. “Going back to the defibrillator comparison: at one time, we only had defibrillators in a hospital. If you coded in a hospital, there was a defibrillator next to you. Now I have one in my office! We are just at the base of that curve with non-invasive neuromodulation.”
Rosen sees a lot of hope for the future of his technology.
“People get it. This generation of 30-somethings and 40-somethings doesn’t just take the word of whoever the healthcare professional is. They don’t just take a pill without going and looking at what the side-effects are, and making a conscious decision as to whether the pharmaceutical treatment is a good trade-off for them,” he said. “They can look at non-invasive therapies and try those first, knowing that if the treatment is not effective for them, the pill is still a secondary option.”