Neurotech Vendors Advance Therapies for Migraine

by James Cavuoto, editor
June 2008

The neurotech market for treating migraine took a step forward this month as vendors of new neuromodulation therapies announced promising study results. Researchers affiliated with at least two key players in the market presented data at the American Headache Society meeting in Boston earlier this month.

Neuralieve, the Sunnyvale, CA developer of a transcranial magnetic stimulation device to treat migraine headache, reported completion of its clinical trial. The results were presented by Richard Lipton, professor and vice chair of neurology at the Albert Einstein College of Medicine in New York.

The randomized, double-blind, parallel-group, sham-controlled clinical study at 16 centers studied the use of Neuralieve’s portable TMS device for treating migraine with aura. The study demonstrated that for migraine with aura, treatment with Neuralieve’s non-invasive TMS treatment system is superior to sham treatment, and led to patients being pain-free at 2 hours, 24 hours, and 48 hours. The trial also confirmed that use of the Neuralieve TMS device, which delivers single pulse TMS treatment, is extremely safe.

As a result, Neuralieve is in the process of submitting pre-market notification to the FDA. Neuralieve is also actively planning additional studies to further demonstrate that its TMS treatment can clinically benefit more people.

Used for years, TMS works by creating a focused magnetic pulse that passes non-invasively through the skull, inducing an electric current. Neuralieve’s TMS device utilizes this technology to send signals to disrupt the abnormal brain waves known as cortical spreading depression; a condition that precedes migraine with aura. Some studies have also suggested that CSD may be present in migraine without aura. By disrupting CSD early, Neuralieve’s TMS treatment system has the potential to preempt headache altogether, reduce the duration or severity of migraine episode, and even reduce the frequency of migraine attacks.

Also at the Boston meeting, Medtronic, Inc. presented data from a multi-center, prospective, randomized, single-blinded, controlled investigational study using its neurostimulation system to stimulate the occipital nerves as a potential approach to treating medically refractory chronic migraines. This study, called Occipital Nerve Stimulation for the Treatment of Intractable Migraine (ONSTIM), included patients who have regularly experienced 15 or more headache days per month that were not responsive to conventional medical therapies.

The ONSTIM study, conducted under an investigational device exemption, collected electronic diary data from 66 patients from nine centers who were followed for three months. “The ONSTIM results suggest that occipital nerve stimulation may be a promising therapy option for individuals who have not had success in treating their chronic migraine and as a result are living with the painful and often debilitating symptoms,” said Joel Saper, founder and director of the Michigan Head Pain and Neurological Institute, Ann Arbor, MI, and principal investigator for the ONSTIM study. “While ONS for chronic migraine requires additional clinical evaluation, our early experience in this study is encouraging and indicates that ONS could possibly help some chronic migraine patients who have exhausted other treatment options.”

In the study, lead wires were placed under the skin near the occipital nerves, which arise from the spinal cord and branch out across the back of the head carrying sensory signals from that region to the brain. The leads were connected to an implanted Medtronic neurostimulator that delivered controlled electrical pulses to the occipital nerves.

It is estimated that nearly 30 million Americans suffer from migraine; more than half report severe impairment or require bed rest during their episodes. In addition, the National Headache Foundation estimates that migraine causes 157 million lost workdays each year due to pain and associated migraine symptoms, resulting in a $13 billion burden to American employers.

Migraine is typically treated with acute drug therapy, most often with a class of agents known as triptans. Although these drugs have been a significant step forward in treating migraine, it is estimated that as many as 40 percent of patients do not do well with triptans. In addition, the drugs can cause serious cardiovascular side effects.