Transnasal Cooling to Reduce Pain from Migraine

经鼻冷却可减轻偏头痛

基本信息

批准号：
10268247
负责人：
BENJAMIN R LANE
金额：
$ 91.51万
依托单位：
KEY TECHNOLOGIES, INC.
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-09-30 至 2023-02-28
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10268247
关键词：
Academic Medical Centers Accident and Emergency department Acute Affect Air American Chronic Clinic Clinical Clinical Data Communities Dependence Device Designs Devices Disease Dose Double-Blind Method Drug usage Economic Burden Emergency department visit FDA approved Fever Fluorocarbons Food and Drug Administration Device Approval Freedom Ganglia Goals Grant Headache Health Expenditures Healthcare Systems Hour Human Humidifier Hyperacusis Intensive Care Units Lead Lidocaine Location Medical Device Designs Methods Migraine Nausea and Vomiting Nerve Neurologic Nose Opioid Opioid Analgesics Oral cavity Pain Patients Persons Pharmaceutical Preparations Phase Photosensitivity Pilot Projects Placebos Population Prevalence Production Protocols documentation Quality of life Randomized Recommendation Recurrence Risk Safety Signal Transduction Single-Blind Study Societies Supervision Testing Throbbing Headaches Time Training United States National Institutes of Health Visit Woman Work addiction associated symptom base cold temperature commercialization cost design efficacy outcomes efficacy study feasibility testing handheld equipment improved men migraine treatment non-drug novel novel strategies operation opioid epidemic opioid overuse pain reduction pain relief pain symptom phase 1 study prescription opioid primary endpoint productivity loss program costs prototype reduce symptoms safety study usability

项目摘要

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.

偏头痛是一种严重致残的神经系统疾病，是全球第六种最严重的疾病，影响超过十亿人。美国偏头痛的患病率正在增加，其中15％患有情节性或慢性偏头痛的人口，女性的可能性高三倍比男人受到影响。偏头痛的全球经济烧伤大约$ 20 美国十亿美元，全球560亿美元。偏头痛也是最常见的原因之一急诊室访问。尽管有治疗建议，许多偏头痛患者仍在处方阿片类止痛药，特别是在急诊科（ED）。一项研究发现阿片类药物的处方为69％的社区ED访问，41％的城市ED访问和12％的学术访问。医疗中心访问。有证据表明，偏头痛的阿片类药物处方可显着贡献不断增长的阿片类药物流行。总体而言，偏头痛的当前疗法次优，昂贵，无效遏制全球阿片类药物流行。有效的未满足需要以及负担得起的急性偏头痛的非药品堕胎疗法，以显着改善生活质量并大大降低了伯恩（Burnen）为我们的医疗保健系统和社会的成本。我们正在开发一种新颖的偏头痛治疗方法除了干净干燥的空气。我们的方法针对螺旋藻神经节（SPG），一个神经束在偏头痛发作中暗示的上呼吸道后面。初步证据已经表明，使用利多卡因或寒冷温度的SPG块可以抑制这种神经的活性束，减轻偏头痛的疼痛和持续时间。鼻子后面的SPG的位置使它很难访问。我们认为，跨纳萨冷却是一种可以减轻此问题的方法偏头痛的快速，方便，无药冷却和缓解疼痛。与我们的其中一项进行可行性测试与假的偏头痛患者相比，原型显示出明显的疼痛缓解。这笔赠款的工作范围将创建，测试和验证新设备的临床级版本我们称为“ Mi-Helper”。该设备将通过完整的设计设计，测试和记录控制足以满足FDA 21 CFR 820.30。我们还将通过两个FDA收集临床数据批准的人类试验，以证明使用跨纳萨冷却的安全性，效率和可用性治疗偏头痛疼痛的方法，无需使用药物或阿片类药物。这项工作将为获得FDA清除率并启动最终产品商业化的下一步。