FDAnews Device Daily Bulletin


June 30, 2006

An experimental device appears to be effective in eliminating or reducing migraine headaches when administered during the onset of the migraine, according to a study conducted at the Ohio State University (OSU) Medical Center.

The device, called transcutaneous magnetic stimulation (TMS), interrupts the "aura phase" of the migraine, often described as "electrical storms" in the brain. Auras are neural disturbances that signal the onset of migraine headaches.

The stimulator sends an electric current through a metal coil, which creates an intense magnetic field. When held against a person's head, this magnetic pulse creates an electric current in the neurons of the brain, interrupting the aura before it results in a throbbing headache.

Patients in the Phase II study reported a significant reduction in nausea, noise and light sensitivity after TMS treatment, said Yousef Mohammad, principal investigator and a neurologist at the OSU Medical Center.

"Perhaps the most significant effect of using the TMS device was on the two-hour symptom assessment, with 84 percent of the episodes in patients using the TMS occurring without noise sensitivity. Work functioning also improved and there were no side effects reported," Mohammad said, adding that the device's pulses are painless and patients reported feeling a "little pressure, but that's all." So far, the device has been tested on 70 people at OSU, he added.

In the study sample, 69 percent of the TMS-treated patients reported mild or no pain at the two-hour post-treatment point compared with 48 percent of the placebo group, Mohammad said.

In addition, 42 percent of the TMS-treated patients graded their headache response "as very good or excellent compared to 26 percent for the placebo group."