Clinical Trials

The Neuralieve TMS device was found to be significantly more effective than placebo control in treating migraine with Aura. The trial studied the use of Neuralieve's Transcranial Magnetic Stimulation (TMS) device for patient administered home treatment of migraine with aura.

In the trial, 201 patients (from 15 centers) who suffer from migraine headaches were asked to use the device at the onset of their aura; 102 received an active TMS device, and 99 were given an identical appearing non-active or “sham" device that did not deliver a magnetic pulse. Patients were instructed to administer two single pulses of TMS. Each pulse is delivered in a millisecond (1/1000 of a second.) Patients recorded migraine pain intensity and symptoms using an electronic diary. Analysis of the primary end point revealed 39% using the TMS Treatment System were pain-free at two hours after treatment, as compared to 22% of those using the "sham" device. With a p-value of 0.018 and a therapeutic gain of 17%, these results are both statistically significant and clinically meaningful. The therapeutic effect is similar to existing treatments for migraine but with markedly reduced adverse events and side effects. There have been no serious adverse events in any of the Neuralieve TMS studies. Patients also reported sustained pain free results at 24 and 48 hour time points (29% and 27% respectively) which would indicate that the migraine was stopped rather than just postponed.