Development and qualification of Talon microIPG to treat Chronic Migraines

用于治疗慢性偏头痛的 Talon microIPG 的开发和鉴定

• 批准号: 10421177
• 负责人: Savannah Chorley
• 金额: $ 109.99万
• 依托单位: NEOGENESIS TECHNOLOGIES, LLC
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-03-01 至 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10421177
• 关键词: 3-Dimensional; Address; Adoption; Adverse event; Affect; American; Anatomy; Animals; Back; Cadaver; Chronic; Clinical; Clinical Research; Development; Devices; Disabled Persons; Disease; Electric Stimulation; Electrodes; Engineering; Environment; Evaluation; Family; Foundations; Goals; Gold; Head; Headache; Headache Disorders; Healthcare; Human; Joints; Label; Lead; Mechanics; Medical Device; Migraine; Modeling; Neck; Neck Pain; Nerve; Neurostimulation procedures of spinal cord tissue; Operative Surgical Procedures; Output; Pain; Patients; Persons; Phase; Physiologic pulse; Preventive treatment; Productivity; Protocols documentation; Quality of life; Reporting; Reproducibility; Research; Safety; Skin; Small Business Innovation Research Grant; Societies; Standardization; System; Techniques; Testing; Therapeutic; Time; Tissues; Treatment Cost; World Health; base; cost; design; disability; effective therapy; exhaust; experimental study; feasibility research; implantable device; implantation; improved; in vivo; in vivo evaluation; innovation; migraine treatment; migration; nervous system disorder; off-label use; preclinical study; prototype; success

Project Summary/Abstract Migraine is the most common neurological disorder and the 3rd cause of disability in people under 50, according to the World Health Organization49. The annual healthcare and lost productivity costs are approximately $36 billion in the US.31 6 million people in the US are chronic migraineurs who have migraines for more than 50% of the month 28,32 of which 78% of them are severely disabled.61 Current therapies help many sufferers, however nearly 1 million of sufferers in the US do not respond to the therapy initial or stop responding over time; this is referred to as Intractable Chronic Migraine (ICM)17,18 These ICM patients who have exhausted traditional therapeutic options and are often desperate for relief typically progress to more invasive therapies such as Occipital Nerve Stimulation (ONS). ONS involves the surgical implantation of an Implantable Pulse Generator (IPG) and stimulation leads (electrical wires) under the skin which deliver low-level electrical stimulation to the occipital nerves. ONS has been effectively used off-label for two decades to treat a variety of headache disorders and is successful in reducing the number of headache days per month with superior efficacy to that of the “gold standard” preventative treatments1-15 where 65% of patients reported excellent or good headache relief after 1 year.12 Unfortunately, ONS therapy has an unacceptable number of device and procedural adverse events (~70%) which are attributable to a large degree to the off-label use of Spinal Cord Stimulation (SCS) systems not designed for this application. Using non-standardized implantation, the protocols, the off-label SCS devices are implanted below the neck with the leads traversing the neck to the occipital nerves located in the head. There currently does not exist an implantable stimulation system that has been designed, developed and qualified for ONS. There consequently exists a significant unmet need in the medical device arsenal for a specialized ONS device and standardized implantation techniques. Until this unmet need is addressed, chronic migraine sufferers will continue to be faced with inadequate and costly treatment options that often create the need for repeated surgical interventions and continued patient suffering. Our long-term goal is to establish a safe, reliable and efficacious ONS chronic migraine treatment proven through extensive bench testing and rigorous clinical studies that support FDA approval, reimbursement and ultimately commercial adoption. NeoGenesis proposes that the key to the clinical and commercial success of ONS therapy is the development of a microIPG system specifically designed for implantation in the back of the head, above the neck joint and closer to the target stimulation tissue (occipital nerves). In the previous Phase 1, Neogenesis successfully completed critical feasibility research to determine the IPG form factor and size for a head-based local stimulation of the occipital nerves. These key inputs comprise the foundational basis for the Phase 2 efforts. Our overall objective for Phase 2 is the design, development and qualification of the Talon microIPG system. We will accomplish this objective by designing and developing the microIPG mechanical packaging and stimulation lead for occipital placement, building and testing the IPG and leads, and validating the system design via pre-clinical studies.

项目摘要/摘要 偏头痛是最常见的神经系统疾病，也是50岁以下人群残疾的第三名原因。 世界卫生组织49。在美国，年度医疗保健和生产率损失约为360亿美元。31 美国有600万人是慢性偏头痛者，在本月中超过50％的偏头痛28,32人中，其中78％ 他们中的严重残障。61当前的疗法帮助许多患者，但是美国近100万患者确实如此 不要对疗法起初做出反应或随着时间的流逝而停止反应；这被称为顽固性慢性偏头痛（ICM）17,18 这些耗尽传统治疗选择的ICM患者，通常迫切需要缓解 进展到更具侵入性的疗法，例如枕神经刺激（ONS）。 ONS涉及手术植入 植入脉冲发生器（IPG）和刺激导线（电线），可提供低水平 对枕神经的电刺激。二十年来，ONS已有效地使用了标签 头痛障碍并成功地减少每月的头痛天数，其效率均优于 在“黄金标准”预防性治疗1-15中，有65％的患者报告了出色或良好的标题缓解 1年后。12不幸的是，ONS治疗的设备和程序不良事件数量不可接受（〜70％） 这很大程度上归功于未为此设计的脊髓刺激（SCS）系统的标签外使用 应用。使用非标准化的植入，规程，标签不可证明的SCS设备在脖子下方植入 随着导线将颈部穿过头部的枕神经。 目前尚不存在设计，开发和资格的植入刺激系统 ons。因此，在医疗设备武器库中对专业的ONS设备和 标准化植入技术。在解决这种未满足的需求之前，慢性偏头痛患者将继续是 面对不足和昂贵的治疗方案，通常会导致需要重复的手术干预措施和 继续患者痛苦。我们的长期目标是建立一个安全，可靠和高效的ONS慢性偏头痛 通过广泛的基准测试和严格的临床研究证明了治疗，这些研究支持FDA批准，报销 并最终采用商业收养。 Neogenesis提出的，即ONS治疗的临床和商业成功的关键是Microipg的发展 专门设计用于植入头部后部，颈部关节上方并更靠近目标的系统 刺激组织（枕神经）。在上一阶段1中，新生成成功完成了关键可行性研究 确定枕骨神经的基于头部的局部刺激的IPG形状和大小。这些关键输入 完成第二阶段工作的基础基础。我们第2阶段的总体目标是设计，开发和 我们将通过设计和开发Microipg来实现这一目标 机械包装和刺激铅用于枕骨放置，建造和测试IPG和铅，并验证 系统通过临床前研究设计。