Clinical Trial Results for Neuralieve’s TMS Treatment System to be Presented at Annual Headache Society Meeting
June 26, 2008 – Sunnyvale, CA – Neuralieve, a medical technology company pioneering a new approach to treat migraine headache, today reported completion of its clinical trial. The results will be presented June 27 during the annual American Headache Society (AHS) scientific meeting in Boston by Dr. Richard B. Lipton, Professor and Vice Chair of Neurology and Professor of Epidemiology and Population Health 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 transcranial magnetic stimulation (TMS) device for treating migraine with aura. The study demonstrated that for migraine with aura, treatment with Neuralieve’s non-drug, 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 is a proven, safe method of studying the brain. It 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 (CSD); 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.
“The study is based on the hypothesis that TMS disrupts CSD in progression. The results prove that TMS is a safe and effective treatment for aura and headache in patients diagnosed with migraine with aura,” said Richard B. Lipton, M.D., lead investigator on the study “This non-drug early treatment modality offers a promising alternative to existing migraine therapies.”
“We are pleased with the study results and the potential of our TMS treatment to help the people out there who suffer from migraine,” said Ting W. Lu, president of Neuralieve. “We are now taking steps to make the device available for physicians to prescribe to patients as soon as possible after regulatory clearance.”
Migraine is a syndrome characterized by recurrent, often excruciatingly-painful headaches. Migraines are classified by type, the most common of which are migraine with and without aura. Migraine with aura involves pain preceded by abnormalities in neurobiological function, most commonly visual disturbances. Migraine without aura is characterized by attacks of unusually intense, temporarily disabling head pain often accompanied by nausea and sensitivity to light and sound. Patients may suffer from migraine with aura, migraine without aura, or both. Up to 30% of migraine sufferers experience migraines with aura.
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.
The safety of single-pulse TMS, as used in Neuralieve’s treatment system, is accepted by the National Institutes of Health (NIH) and National Institute of Neurologic Disease and Stroke (NINDS). Neuralieve worked with its medical advisory board to design the trial based upon the promising results seen in feasibility studies of TMS Treatment for migraine. Studies at Ohio State University, Borgess Research Institute and McMaster University utilized an in-clinic based TMS Treatment System. This research led to the design of a portable system which was then utilized in the multi-center randomized trial to assess its safety and efficacy in treating migraine with aura.
Neuralieve is a private company located in Sunnyvale, California. For full clinical trial results, please visit the company’s website at www.Neuralieve.com.
CAUTION: Investigational Device. Federal or (United States) law limits device to investigational use.