The StimRelieve Halo Migraine System consists of a tiny implant inserted into the patient’s forehead and an external transmitter worn on the ear, which provides energy and therapy to the implanted device
Last year StimRelieve, a privately held medical device company, received FDA Investigational Device Exemption approval to launch a clinical trial of the device.
This clinical trial is currently open for patient enrollment and will assess the safety and effectiveness of occipital and supraorbital nerve stimulation using the StimRelieve Halo Migraine System for the treatment of chronic migraines, according to the company.
The StimRelieve Halo Migraine System is based on wireless neuromodulation technology and is implantable with a standard gauge needle, thus eliminating the need for extensive surgery to the face, head and neck.
Unlike other devices, there is no implanted battery pack placed in the patient as the transmitter worn on the ear provides power for the implant.
The company said that 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.
Laura Tyler Perryman, StimRelieve chairman and president, said: “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.
“If this study demonstrates safety and effectiveness, StimRelieve can help millions of people who are suffering from chronic migraines, without the need for extensive surgery or bulky implants in their chest.”