Brainpower

Dr. Robert Fischell's treatment device could provide relief to those who suffer painful, aura-accompanied migraines

The New Jersey-based American Headache Society, a professional society of health care providers, estimates that 28 million Americans - about one in five women and one in 20 men - suffer from migraines with or without aura. The higher incidence for women is probably related to fluctuation in estrogen, said Jack Gladstein, associate professor of pediatrics and neurology at the University of Maryland School of Medicine.

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.

"Those with the placebo device, the headache eventually went away by itself," said Dr. Stephen D. Silberstein, director of the Jefferson Headache Center in Philadelphia, one of 16 medical facilities in the U.S. where the Neuralieve was tested. "The headaches in all the subjects went away, but it went away much faster for those using the device than those not using the device."

Dr. Richard B. Lipton, lead investigator on the study and a professor and vice chair of neurology at Albert Einstein College of Medicine in the Bronx, N.Y., said that the study "shows that TMS is a safe and effective treatment for the 7 million Americans who have migraine with aura."

The Neuralieve is among several biotechnology devices created by Fischell, who has 150 registered U.S. patents. They include an implantable heart monitor with a buzz alarm that warns patients to go to the hospital the moment an artery experiences blockage, even before the onset of pain. The device then downloads the patient's data for doctors at the hospital.

"Every summer, a few of my associates and I have what we call an innovation retreat," Fischell said. "We get together and say, 'What does the world need to be invented?' and we try to invent it."

Fischell's latest invention may give benefits to sufferers of migraine aura, although as Fischell discovered, not all auras are followed by migraine.

In fact, for some, aura occurs during migraine. For others, it doesn't occur at all.