The first time Howard County, Md., inventor Dr. Robert Fischell experienced a migraine symptom known as an aura, he had no clue what was happening. Images of dancing circles crowded his vision, and when the circles grew larger, he thought he was about to have a stroke.
Suddenly, the aura stopped and to Fischell's surprise, and relief, no ailment followed. “Oh, thank God,” he said.
Now the maker of the first implantable insulin pump, the rechargeable pacemaker and various coronary stents has invented a handheld device that targets the aura en route to stopping a migraine – a painful, sometimes debilitating headache disorder – before it starts.
Fischell's Neuralieve Transcranial Magnetic Stimulation (or TMS) Treatment System device is creating a buzz throughout medical circles – and could provide hope for the millions of Americans who suffer from aura-accompanied migraine headaches.
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Having received satisfactory results in testing the device, Fischell applied to the U.S. Food and Drug Administration in June for approval to manufacture the device for commercial sale. He hopes the device will be on the market (via prescription only) by the beginning of next year.
Fischell's contraption looks like a box with two handles on opposite sides. At the onset of an aura – a neurological disturbance during which nerves in the brain spontaneously fire – the user places the device at the back of his head near the part of the brain called the occipital cortex, where auras begin. The press of a trigger on the device emits two magnetic pulses 15 seconds apart. The pulses silence the nerve activity, shutting down the aura before migraine pain sets in.
“The patients do feel a tingle in their scalp, which is not at all unpleasant. That is really our only side effect, and it is not at all a problem,” said Fischell, 79.
In a clinical trial involving the Neuralieve TMS and a replica device, Fischell's machine outperformed the replica, with 39 percent of its users pain-free at two hours after treatment, compared with 22 percent of placebo users who didn't have pain after two hours. At both the 24-hour and 48-hour intervals, the number of TMS-treated patients free from pain was 13 percent greater than that of the placebo groups at the respective intervals. None of the patients reported serious side effects.
“Migraine is a mechanism that is built into the human brain. We all possess it, and it becomes active by an efficient build-up of its triggers,” said David Buchholz, associate professor of neurology at the Johns Hopkins University and author of a self-help guide, “Heal Your Headache.” Migraine triggers include stress, hormones, weather changes, sleep, certain foods (a long list that includes caffeine, nuts, alcohol, vinegar and processed meats) and acid reflux drugs.
Buchholz said that migraine sufferers should first try to prevent the condition by targeting many of its factors: relieve stress, get sufficient sleep and avoid dietary trigger foods and certain medicines.
“The bottom line from my perspective is that it's best to prevent it rather than to walk around with some expensive hardware to zap yourself every time you get an aura,” he said.