U44NS119974

Migraine is a severely disabling neurologic condition and is the sixth most disabling disorder worldwide, affecting over a billion people. The prevalence of migraine in the U.S. is increasing, with 15% of the population suffering from either episodic or chronic migraine, and women are three times more likely to be affected than men. The global economic burden of migraine is staggering at approximately $20 billion in the U.S. and $56 billion worldwide per year. Migraine is also one of the most common reasons for emergency room visits. Despite treatment recommendations, many migraine patients are still prescribed opioid pain medications, particularly in emergency departments (EDs). One study found that opioids were prescribed at 69% of community ED visits, 41% of urban ED visits, and 12% of academic medical center visits. It is evident that opioid prescriptions for migraine are contributing significantly to the growing opioid epidemic. Overall, current therapies for migraine are suboptimal, expensive and ineffective in curbing the global opioid epidemic. There is an enormous unmet need for an effective and affordable non-drug abortive therapy for acute migraine to significantly improve quality of life and substantially reduce the cost burden to our healthcare system and society. We are developing a novel approach to migraine treatment that is simple, safe, and drug free, using nothing but clean, dry air. Our approach targets the sphenopalatine ganglion (SPG), a nerve bundle behind the upper airway that is implicated in the onset of migraine headaches. Preliminary evidence has shown that SPG blocks using lidocaine or cold temperatures can inhibit activity from this nerve bundle, reducing the pain and duration of migraines. The location of the SPG behind the nose makes it hard to access. We believe transnasal cooling is an approach that can alleviate this problem, providing fast, convenient, drug-free cooling and pain relief for migraineurs. Feasibility testing with one of our prototypes showed significant pain relief in those with migraines compared to sham. The scope of work from this grant will create, test and validate a clinical-grade version of a new device that we are calling the ‘Mi-Helper’. The device will be designed, tested and documented with full design controls sufficient to satisfy FDA 21 CFR 820.30. We will also collect clinical data through two FDA approved human trials to demonstrate the safety, efficacy and usability for using our transnasal cooling approach for treating migraine pain, without the use of drugs or opioids. This work will set the stage for the next step of obtaining FDA clearance and initiating commercialization of the final product.More than 35 million Americans suffer from migraines, which are recurrent episodes of throbbing headache accompanied by nausea, vomiting, photosensitivity and noise sensitivity. The primary method of treating migraine is with daily medication, including a significant amount of opioids, which can lead to dependencies and addictions. This project will develop and clinically validate a new product that will reduce or eliminate migraine pain without the use of any drugs or opioids.