On December 11, 2015, StimRelieve LLC announced that it received FDA Investigational Device Exemption (IDE) approval of a clinical trial for an implantable device for the treatment of chronic migraine which is resistant to other methods of treatment, such as NSAIDs, combination drug therapy, and migraine-specific treatments. This device is actually the smallest in the world to deliver treatment through the skin.
As many of us here at Migraine.com know all too well, the impact of chronic migraine on work and productivity is a tremendous one, in addition to the impact on one’s overall quality of life. Since current, conventional treatments are limited and have mixed results, the potential effect of a new treatment such as this could be enormous. What this clinical trial would do is measure the effectiveness and safety of occipital and supraorbital nerve stimulation using the StimRelieve Halo Migraine System, which is based on wireless neuromodulation technology, and is able to be implanted with a standard gauge needle – thereby enabling people to forego extensive surgery to the head, neck, and face. Additionally, a battery pack would not need to be implanted; instead, a person could wear a discreet transmitter on the ear which then provides therapy to the implanted device. The study’s goal is to reduce migraine attacks by 30 percent, without an increase in medication in three months’ time.
FDA Grants StimRelieve IDE Approval for a Wireless Stimulator System For The Treatment of Chronic Migraines. (2015, December 11). Retrieved December 14, 2015, from http://www.marketwatch.com/story/fda-grants-stimrelieve-ide-approval-for-a-wireless-stimulator-system-for-the-treatment-of-chronic-migraines-2015-12-11/print