“Take two aspirins and give me a call in the morning if you don’t feel better.” Many sufferers of migraines, facial pains, or chronic or cluster headache have probably received this canned response from their physicians time and time again. Only after taking large doses of aspirin are these aches temporarily relieved, if at all. Soon, there will be a new and more effective treatment option available for these patients: electronic aspirin.
The scientists at Autonomic Technologies Inc. (ATI) in Redwood City, California have developed a state-of-the-art neurostimulation system that can be used to treat severe headaches and migraines. The system is a stimulator — about the size of an almond — that is implanted through a surgical incision in the upper gum near the molars, usually on the side where headaches most often occur for that person. The lead tip of the implant is placed at the sphenopalatine ganglion (SPG) nerve bundle behind the cheekbone, a region that has long been targeted by clinicians for its potential to relieve severe headaches. Traditionally, a physician would apply lidocaine, a common local anesthetic, to achieve a nerve block and stop the ache. Thanks to this technology, patients suffering from headaches can hold a remote control up to the implant and stimulate the SPG nerves, blocking neurotransmitters that cause the pain. When the headache is treated, the remote control is simply removed from the cheek to deactivate the therapy. The patients can then exercise full control over the amount of treatment received without the risk of external scarring.
To evaluate both the efficacy and safety of the ATI Neurostimulation System, a multi-center study was conducted in Europe — the results were quite impressive. They showed that the ATI Neurostimulation System demonstrated clinical effectiveness in treating cluster headache via alleviation of headache disability and overall improvement in quality of life. In the study of 22 patients, more than 70 percent experienced a reduction in headache frequency by 50 percent or more, compared to the four-week period prior to participating in the study. The system was well-tolerated and side effects were comparable to similar surgical procedures, tending to be transient. “These results are extremely encouraging,” said Dr. Jean Schoenen, M.D., coordinator of the Headache Research Unit at the University of Liege in Belgium. “Chronic cluster headache sufferers are highly disabled by their condition, which causes immense pain and often prevents patients from leading a normal life. The investigators and I look forward to continuing to study this novel therapy in cluster headache, as well as future research in severe migraine.”
Cluster headache, also known as “suicide headache,” is a neurological condition characterized by an intense stabbing pain localized in one eye, often accompanied by swelling, tearing and nasal congestion. In fact, the pain inflicted by this condition is recognized as one of the most severe pains known to man; people who suffer from it must sometimes endure headache attacks several times a day, each lasting between 15 minutes to three hours. Today, there is no known cure for cluster headache, so seeing positive outcomes from the trials conducted involving the use of such technology is exciting for researchers, physicians and patients alike.
As of right now, some headache centers in Germany and Denmark are already treating some cluster headache patients with the ATI Neurostimulation System. The U.S. Food and Drug Administration (FDA) approved domestic testing of the device in the summer of 2014 and, as of that August, clinical trials involving the ATI Neurostimulation System had already begun here in the United States. The multi-center FDA trial calls for a total of 120 test subjects to receive the device. The study will continue over the course of several years before the system is available for commercial use in the United States. “We are extremely pleased,” said Ben Pless, president and CEO of Autonomic Technologies. “We look forward to continued studies of our technology for cluster headache as well as for migraine, with the hope that our work may one day offer relief to millions of people.”