Drug Free Nerve Block Device for the Relief of Pain and Symptoms in Migraines and other Headaches

用于缓解偏头痛和其他头痛的疼痛和症状的无药物神经阻滞装置

• 批准号: 10386456
• 负责人: Stephen Popielarski
• 金额: $ 99.81万
• 依托单位: THERMAQUIL, INC.
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-04-29 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10386456
• 关键词: Adverse event; Affect; Aftercare; Algorithms; American; Analgesics; Auras; Authorization documentation; Back; COVID-19 pandemic; Chronic; Chronic Headaches; Clinical; Clinical Trials; Complex; Data; Development; Devices; Diagnosis; Double-Blind Method; Drug usage; Effectiveness; Electrocardiogram; Emergency department visit; Enrollment; Equipment; Frequencies; Functional Magnetic Resonance Imaging; Guidelines; Head; Head and neck structure; Headache; Heating; Home; Hospital Administrators; Hour; Human; Individual; Institutional Review Boards; International; Interview; Investments; Lead; Liquid substance; Manipulative Therapies; Marketing; Measures; Medical; Migraine; Monitor; Narcotics; Neck Pain; Nerve; Nerve Block; Neural Conduction; Neurologic; Pain; Pain Clinics; Pain management; Pain-Free; Participant; Patients; Pharmaceutical Preparations; Pharmacologic Substance; Phase; Physical therapy; Physicians; Physiological; Preparation; Prevention; Privatization; Quality of life; Randomized; Randomized Controlled Trials; Recording of previous events; Resort; Rest; Safety; Schools; Services; Severities; Societies; Study Subject; Symptoms; System; Testing; Universities; Work; arm; base; chronic pain; conditioned pain modulation; design; diaries; health care service utilization; inclusion criteria; neuroregulation; novel; novel therapeutics; opioid use; pain patient; pain reduction; pain relief; pain signal; pain symptom; placebo group; prescription opioid; prevent; primary endpoint; programs; prospective; reduce symptoms; response; secondary endpoint; sham-controlled study; side effect; success; transmission process; treatment duration; validation studies

Abstract: Migraines and headaches are difficult to treat debilitating neurological conditions that leave physicians and their patients with few options for sustained relief from severe chronic pain. All available therapies have considerable side-effects or limitations, leading many patients to resort to drug cocktails including narcotics. To reduce or eliminate the need to use opiates and systemic pharmaceuticals to treat headaches and migraine, Thermaquil developed the first noninvasive, drug-free, patient-controlled reversible nerve block device for long term pain management based on novel mechanisms-of-action that we discovered. Thermaquil has met with more than 300 physicians and headache patients who have vetted and guided the development of Thermaquil’s noninvasive nerve block device. The system is designed to easily be used during normal daily activities. We’ve demonstrated clear efficacy of thermal neuromodulation in single-arm studies with highly complex patients who have tried and failed all other available treatments. Our 45 participants’ baseline pain of 6.1 ± 1.7 was significantly reduced to 2.6 ± 2.5 ( p < 0.05, p = 6e-12). Most participants have had constant headache every day over the past 28 days, which would exclude them from most other headache and migraine clinical trials. The proposed study begins with a 28-day lead-in phase to establish a baseline for participant headache frequency, intensity, medications used, other healthcare utilization, and quality of life. After the baseline period, all participants are randomized into active or control arms and given a single treatment. The study continues for 12 weeks with active versus control therapy arms before all participants are given active therapy for an additional 12 weeks. This sham-controlled study will provide evidence of the safety and effectiveness of the Thermaquil device relieving migraine and headache attacks. Successful completion of the project will 1) justify the company to pursue a larger efficacy/pivotal trial to move towards regulatory approval and 2) result in additional investment opportunities for Thermaquil to expedite our clinical program to rapidly bring this product to market to help stop migraine and other pain for individuals with chronic migraine or other headaches.

摘要： 偏头痛和头痛很难治疗，这些虚弱的神经疾病让医生和 他们的患者几乎没有从严重的慢性疼痛中持续缓解的选择。所有可用的疗法都有 相当大的副作用或局限性，导致许多患者求助于包括麻醉剂在内的鸡尾酒药物。至 减少或消除使用鸦片类药物和全身药物治疗头痛和偏头痛的需要， 长久以来，Thermaquil开发了第一个无创、无药物、患者可控的可逆性神经阻滞装置 基于我们发现的新的作用机制的终端疼痛管理。 Thermaquil已经会见了300多名医生和头痛患者，他们审查和指导了 Thermaquil无创神经阻滞器的研制。该系统的设计便于在以下情况下使用 正常的日常活动。我们已经在单臂研究中证明了热神经调节的明显疗效 高度复杂的患者，他们尝试了所有其他可用的治疗方法，但都失败了。我们的45名参与者 基线疼痛由6.1±1.7降至2.6±2.5(p&lt；0.05，p=6e-12)。大多数参与者都有 在过去的28天里，每天都有持续的头痛，这将他们排除在大多数其他头痛之外 以及偏头痛的临床试验。 拟议的研究从28天的先导阶段开始，以建立参与者头痛的基线 频率、强度、使用的药物、其他医疗保健用途和生活质量。在基准期之后， 所有参与者被随机分为活动组或对照组，并给予单一治疗。研究仍在继续 在所有参与者接受主动治疗之前，接受12周的主动治疗和对照治疗 额外的12周。这项假对照研究将提供证据，证明 Thermaquil缓解偏头痛和头痛发作的装置。该项目的成功完成将证明 该公司将进行更大规模的疗效/关键试验，以获得监管部门的批准和2)结果 Thermaquil的额外投资机会加快了我们的临床计划，以迅速推出该产品 推向市场，帮助患有慢性偏头痛或其他头痛的个人止住偏头痛和其他疼痛。