Transnasal Cooling to Reduce Pain from Migraine

偏头痛是一种严重致残的神经系统疾病，是全球第六大致残障碍， 影响着十多亿人。偏头痛在美国的患病率正在上升，15%的美国人 患有发作性或慢性偏头痛的人群，女性患偏头痛的可能性是前者的三倍 比男人更容易受影响。全球偏头痛的经济负担约为20美元，令人震惊 美国每年10亿美元，全球每年560亿美元。偏头痛也是最常见的原因之一。 用于急诊室就诊。尽管有治疗建议，但许多偏头痛患者仍然 处方阿片类止痛药，尤其是在急诊科。一项研究发现， 69%的社区ED就诊、41%的城市ED就诊和12%的学术就诊使用阿片类药物 医疗中心来访。显然，偏头痛的阿片类药物处方在很大程度上有助于 日益严重的阿片类药物流行。总体而言，目前治疗偏头痛的方法是次优的、昂贵的和 在遏制全球阿片类药物流行方面效果不佳。有一个巨大的未得到满足的需求，有效的 和负担得起的非药物流产治疗急性偏头痛，显著提高生活质量 并大幅降低我们医疗保健系统和社会的成本负担。 我们正在开发一种治疗偏头痛的新方法，这种方法简单、安全、不含药物，使用 除了干净干燥的空气什么都没有。我们的方法针对的是蝶腭神经节(SPG)，一种神经束 在上呼吸道后面，这与偏头痛的发作有关。初步证据 研究表明，用利多卡因或低温阻断SPG可以抑制该神经的活动。 捆绑，减轻偏头痛的疼痛和持续时间。鼻后SPG的位置使它 很难进入。我们相信经鼻冷却是一种可以缓解这个问题的方法，提供 对偏头痛患者快速、方便、不含药物的降温和止痛。与我们的一家公司进行可行性测试 与假头痛相比，原型试验显示偏头痛患者的疼痛显著缓解。 这项拨款的工作范围将创建、测试和验证一种新设备的临床级别版本 我们把它叫做‘小米帮手’。该装置将按照完整的设计进行设计、测试和记录 控制足以满足FDA 21 CFR 820.30的要求。我们还将通过两个FDA收集临床数据 批准的人体试验，以证明使用我们的鼻腔冷却的安全性、有效性和可用性 治疗偏头痛的方法，不使用药物或阿片类药物。这项工作将为 获得FDA批准并启动最终产品商业化的下一步。

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.