People who suffer from migraines often complain about excruciating headache pain, sensitivity to light and sound, nausea, and in some cases neurological disturbances.
Clinical trial results presented Saturday at the annual meeting of the American Headache Society (AHS; Mount Royal, New Jersey) in Boston suggest a hand-held magnetic device could ease the pain for migraine sufferers.
The recently completed trial studied a portable transcranial magnetic stimulation (TMS) device developed by Neuralieve (Sunnyvale, California). The results were presented by Richard Lipton, MD, professor and vice chair of neurology and professor of epidemiology and population health at the Albert Einstein College of Medicine (New York).
Although headache pain is one of the most recognized symptoms of migraine, Neuralieve said, about 20% to 35% of patients also suffer a set of neurological symptoms, called Auras. These symptoms usually start immediately before a migraine headache and can include visual symptoms, such as flickering lights or decreased vision, sensory symptoms such as numbness, or speech disturbances.
These neurological disturbances that precede a migraine headache in some patients are caused by cortical spreading depression (CSD), a wave of abnormal nerve activity that travels slowly across the cortex, the company said.
The Neuralieve TMS device is designed to allow the patient to hold it to the back of their head. It works, the company says, by creating a focused magnetic pulse that passes non-invasively through the skull, inducing an electric current. The TMS device uses this technology to send signals to disrupt CSD.
Some studies also have suggested that CSD may be present in migraine without aura, the company noted. By disrupting CSD early, Neuralieve says its TMS treatment system has the potential to preempt headache altogether, reduce the duration or severity of a 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 Lipton, lead investigator on the study "This non-drug early treatment modality offers a promising alternative to existing migraine therapies."
The randomized, double-blind, parallel-group, sham-controlled clinical study at 16 centers studied the use of Neuralieve's TMS device for treating migraine with aura (pain preceded by abnormalities in neurobiological function, most commonly visual disturbances).
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 two hours, 24 hours and 48 hours. The trial also confirmed that use of the device, which delivers single pulse TMS treatment, is "extremely safe," the company said. As a result, Neuralieve is in the process of submitting pre-market notification to the FDA.
The company said it is planning additional studies to further demonstrate that its TMS treatment can clinically benefit more people.
"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 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."
Nearly 30 million Americans suffer from migraine, Neuralieve estimates, and more than half report severe impairment or require bed rest during their episodes. In addition, the National Headache Foundation (Chicago) 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, the company estimates that as many as 40% of patients do not do well with triptans. In addition, the drugs can cause serious cardiovascular side effects, Neuralieve said.
The safety of single-pulse TMS, as used in Neuralieve's treatment system, is accepted by the National Institutes of Health and National Institute of Neurologic Disease and Stroke (NINDS). Neuralieve said it 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 (Columbus), Borgess Research Institute (Kalamazoo, Michigan) and McMaster University (Hamilton, Ontario) used an in-clinic based TMS treatment system. This research led to the design of a portable system, which was then used in the multi-center randomized trial to assess its safety and efficacy in treating migraine with aura, the company noted.