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，是全球第六大致残疾病，在美国，偏头痛的患病率正在上升，占总人口的 15%。患有阵发性或慢性偏头痛的人群，女性的可能性是其三倍偏头痛造成的全球经济负担约为 20 美元，令人震惊。在美国，偏头痛每年造成 560 亿美元的损失，也是最常见的原因之一。尽管有治疗建议，许多偏头痛患者仍然需要去急诊室就诊。处方阿片类止痛药，尤其是在急诊室 (ED)。 69% 的社区急诊就诊、41% 的城市急诊就诊和 12% 的学术急诊就诊使用阿片类药物显然，阿片类药物处方对偏头痛的影响很大。总体而言，目前的偏头痛治疗方法效果欠佳、昂贵且昂贵。无法有效遏制全球阿片类药物的流行。对有效药物的需求尚未得到满足。和负担得起的非药物流产疗法治疗急性偏头痛，显着提高生活质量并大幅减轻我们的医疗保健系统和社会的成本负担。我们正在开发一种简单、安全且无需药物的偏头痛治疗新方法，使用我们的方法只针对蝶腭神经节 (SPG)，即一种神经束。初步证据表明，上呼吸道后方与偏头痛的发作有关。研究表明，使用利多卡因或低温的 SPG 阻滞剂可以抑制该神经的活动 SPG 位于鼻子后面，可减少偏头痛的疼痛和持续时间。我们相信经鼻冷却是一种可以缓解这个问题的方法，提供与我们的一位医生一起进行快速、方便、无药物的降温和缓解疼痛的可行性测试。与假手术相比，原型对偏头痛患者的疼痛有显着缓解。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将其称为“Mi-Helper”，该设备将通过完整的设计进行设计、测试和记录。足以满足 FDA 21 CFR 820.30 的控制措施我们还将通过两个 FDA 收集临床数据。经批准的人体试验证明使用我们的经鼻冷却的安全性、有效性和可用性这项工作将为治疗偏头痛奠定基础，无需使用药物或阿片类药物。下一步是获得 FDA 许可并开始最终产品的商业化。