Investigational Device Exemption (IDE) approval to launch a clinical trial comparing the StimRelieve Halo Migraine System to more conservative options has been granted by the US FDA. According to StimRelieve, this is the smallest percutaneously implantable device for the treatment of chronic migraine available in the world. The product uses wirelessly-powered neurostimulators leveraging nanotechnology for the treatment of chronic migraines.
“To date, treatments for chronic migraines have had limited and inconsistent results,” says Konstantin Slavin, professor of neurosurgery at the University of Illinois, Chicago. “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.”
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. The StimRelieve Halo Migraine System is based on wireless neuromodulation technology. It is among the world’s smallest devices – 95% smaller than other implanted options – and, according to StimRelieve, is implantable with a standard gauge needle, thus eliminating the need for extensive surgery to the face, head and neck.
There is no implanted battery pack placed in the patient. Instead, a discreetly-worn external transmitter worn on the ear provides energy and therapy to the implanted device. The goal of the study is to achieve a 30% 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.