High-Resolution, Spinal Cord Stimulation for Non-Opioid Treatment of Neuropathic Pain

高分辨率脊髓刺激用于非阿片类药物治疗神经性疼痛

• 批准号: 10488074
• 负责人: Bryan L McLaughlin
• 金额: $ 194.7万
• 依托单位: MICRO-LEADS, INC.
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-30 至 2025-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10488074
• 关键词: Action Potentials; Acute; Animals; Back; Cadaver; Capital; Chronic; Clinical; Clinical Trials; Computer software; Contracts; Dependence; Development; Device Designs; Device or Instrument Development; Devices; Electric Stimulation; Electrodes; Electromyography; Electronics; Electrophysiology (science); Employment; Ensure; Etiology; Family Felidae; Feasibility Studies; Feedback; Fiber; Foot Pain; Geometry; High Prevalence; Human; Implant; Inguinal region; Injury; Institutional Review Boards; Intractable Pain; Label; Lateral; Lead; Letters; Limb structure; Longevity; Longitudinal Studies; Lower Extremity; Manufacturer; Maps; Measures; Mechanics; Medial; Medical center; Mental Depression; Mental Health; Morbidity - disease rate; Nerve Root Compressions; Neurostimulation procedures of spinal cord tissue; Operative Surgical Procedures; Opiate Addiction; Opioid; Overdose; Pain; Paralysed; Patients; Performance; Persons; Phase; Physiologic pulse; Positioning Attribute; Protocols documentation; Quality of life; Resolution; Risk; Running; Safety; Shapes; Sheep; Small Business Innovation Research Grant; Specificity; Spinal; Spinal Cord; Spinal Ganglia; Sterilization; Structure; Suicide; Technology; Testing; Thick; Tissues; Validation; Vertebral column; Width; Work; Writing; addiction; biomaterial compatibility; chronic neuropathic pain; chronic pain; cognitive function; commercialization; debilitating pain; design; design verification; dorsal column; dorsal horn; human subject; improved; knee pain; manufacture; meetings; neural; non-opioid analgesic; novel; operation; opioid abuse; opioid use; pain reduction; pain relief; painful neuropathy; pilot test; prescription opioid; programs; safety study; safety testing; spinal nerve posterior root; success; wireless

In this SBIR FastTrack proposal, Micro-Leads will develop HD64—a high-resolution, 64- channel spinal cord stimulation therapy to provide more pain relief with greater specificity for those suffering from chronic neuropathic pain and opioid dependence. Over 25 million in the U.S. suffer from debilitating pain in the trunk and extremities and 55% depend on opioids to ease their suffering. Opioid abuse has claimed the lives of over 200,000 over the past decade and has resulted in devastating reductions in quality of life, in ability to work, and in mental health for the living. Spinal cord stimulation (SCS) has provided pain relief for 60% of those with chronic extremity pain and eliminated opioid use entirely in more than 50%. Despite these advantages, SCS has had a limited success treating isolated pain of the knee, foot, groin, or low-back. The lateral positioned fibers of the spinal cord (ex. the dorsal root entry zone and dorsal horn) represent a more selective neural targeting opportunity yet current, implantable plate-type surgical leads are too rigid and bulky to access these fibers without a significant risk of paralysis or nerve root compression. HD64 provides an ultra-thin and conformal blanket of stimulation contacts across the entire width of the spinal cord. Active-lead technology embeds a tiny electronic chip within the surgical lead and doubles the number of therapy contacts compared with current technology without increasing the number of lead-wires. Collectively, these features improve therapy and simplify surgical workflow. A novel Active-Lead Controller Implantable Pulse Generator (AL-IPG) powers the chip safely, synchronizes with the active-lead electronics, configures the 8 programmable “therapy groups”, and ensures therapy pulses are delivered to the tissue. HD64 therapy is a highly significant, novel solution for the treatment of patients suffering from chronic pain and opioids. PHASE 1: A cadaveric pilot run followed by a non-significant risk intraoperative study (n=6) will be performed to inform the geometric and electrophysiological design parameters of high-resolution HD64 arrays. The study will evaluate activation of medial and lateral spinal targets as measured by intraoperative neuromonitoring of electromyography. At the end of Phase 1, the clinical feasibility of HD64 surgical leads will be established. PHASE 2: In Phase 2, we have HD64 active leads assembled by a GMP manufacturer. We will develop an external Active Lead Pulse Generator and charger which will be submitted for IDE approval. We will perform an Early Feasibility Study Human Trial using active HD64 and AL-IPG hardware (n=10 subjects, n=23 therapy groups, n=2 waveforms). During Phase 2, we will also perform mechanical and electrical design verification testing and chronic safety studies in large animals to demonstrate functional performance to inform the final device. By the end of Phase 2, we will have completed all necessary tasks to inform the final device design and to enable follow-on implanted longitudinal studies of chronic pain and opioid reduction.

在这个SBIR FastTrack提案中，微铅将发展HD64，高分辨率为64- 通道通道脊髓刺激疗法，以提供更多的疼痛缓解，并为苦难者提供更大的特异性 来自慢性神经性疼痛和阿片类药物依赖性。在美国，超过2500万人遭受使人衰弱的疼痛 在树干和四肢中，有55％的人依靠阿片类药物来减轻其痛苦。阿片类药物滥用已声称 在过去的十年中，超过200,000多个生活，导致生活质量的毁灭性降低，能力 工作，以及生活的心理健康。脊髓刺激（SC）可减轻60％的疼痛 那些慢性肢体疼痛并消除了阿片类药物的使用完全超过50％。尽管有这些优势， SCS的成功治疗了膝盖，脚，腹股沟或低背部的孤立疼痛的成功有限。横向位置 脊髓的纤维（例如背根进入区域和背喇叭）代表更具选择性的神经靶向 机遇但最新的，可植入的板型外科手术导线过于僵硬和笨重，无法在没有的情况下使用这些纤维 瘫痪或神经根压缩的显着风险。 HD64提供了整个刺激接触的超薄和保形的毯子 脊髓。主动铅技术将一个微小的电子芯片嵌入手术线索中，并加倍数字 与当前技术相比，治疗接触的距离而没有增加铅线的数量。共同 这些功能改善了治疗并简化了手术工作流程。一种新型的主动铅控制器植入 脉冲发生器（Al-ipg）安全为芯片提供动力，与主动铅电子同步，配置8 可编程的“治疗组”，并确保将治疗脉冲传递到组织中。 HD64治疗是一种高度 用于治疗患有慢性疼痛和阿片类药物的患者的重要解决方案。 阶段1：尸体飞行员运行，然后进行非显着风险术中研究（n = 6） 执行以告知高分辨率HD64阵列的几何和电生理设计参数。 该研究将评估术中测量的培养基和侧面脊柱靶标的激活 肌电图的神经监测。在第1阶段结束时，HD64手术铅的临床可行性将 建立。第2阶段：在第2阶段，我们拥有由GMP制造商组装的HD64主动铅。我们将 开发外部活动铅脉冲发生器和充电器，将提交IDE批准。我们将 使用Active HD64和AL-IPG硬件进行早期可行性研究人类试验（n = 10受试者，n = 23 治疗组，n = 2波形）。在第2阶段，我们还将执行机械和电气设计 验证测试和大型动物的慢性安全研究，以证明功能性能以告知 最终设备。到第二阶段结束时，我们将完成所有必要的任务，以告知最终设备 设计并实现慢性疼痛和阿片类药物减少的后续植入纵向研究。