Medical device maker, StimRelieve, received approval from the FDA to begin a clinical trial to test the world’s smallest percutaneous implantable device for the treatment of migraine.
This clinical trial will assess the safety and effectiveness of occipital and supraorbital nerve stimulation using the StimRelieve Halo Migraine System for the treatment of chronic migraines. Study participants will include those who have been unable to manage chronic migraine with more conservative therapies such as NSAIDs, migraine-specific drugs, or combination drug therapy.
The goal of the study is to achieve a 30 percent reduction in headaches with no increase in medication at three months as compared to the control group that will have no active treatment during the same period.
“To date, treatments for chronic migraines have had limited and inconsistent results,” said Konstantin Slavin, MD, Professor of Neurosurgery at the University of Illinois, in a press release. “Chronic migraine headache pain is a crippling condition, disabling millions of Americans every year. If determined safe and effective, StimRelieve’s wireless neuromodulation device offers a promising option for alleviating and controlling this type of condition so that those living with this pain can better function and go on with their lives.”
The device uses wirelessly-powered neurostimulators leveraging nanotechnology. The company says it is “among the world’s smallest devices – 95 percent smaller than other implanted options – and is implantable with a standard gauge needle, thus eliminating the need for extensive surgery to the face, head and neck.”
Small size and the elimination of an implanted battery makes the surgical procedure less invasive as compared to other technology approaches, which implant the battery power source. The device gets its power from an external transmitter, which is worn on the ear – not too dissimilar to a cochlear implant.
“We are delighted to be moving forward with this study to demonstrate the potential of our product platform to address a wide variety of chronic issues with minimally-invasive neuromodulation treatments,” said Laura Tyler Perryman, StimRelieve chairman and president. “If this study demonstrates safety and effectiveness, StimRelieve can help millions of people in the U.S. who are suffering from chronic migraines, without the need for extensive surgery or bulky implants in their chest.”
The International Headache Society defines chronic migraine as more than fifteen headache days per month over a three month period of which more than eight are cluster headaches, in the absence of medication over use. Episodic migraine is the other migraine sub-type, which is defined as less than 15 headache days per month.