Transformation of Dormant Spinal Networks to Mitigate Symptoms of Neurogenic Bladder

转变休眠脊柱网络以减轻神经源性膀胱的症状

• 批准号: 10325406
• 负责人: Parag Gad
• 金额: $ 95.64万
• 依托单位: SPINEX, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-15 至 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10325406
• 关键词: Agonist; Anti-Cholinergics; Attention; Awareness; Bladder; Bladder Control; Botulinum Toxins; Brain; Caring; Catheters; Chronic; Clinical; Clinical Research; Clinical Trials; Communication; Conscious; Data; Data Engineering; Dependence; Devices; Engineering; Ensure; Esthesia; Functional disorder; Future; Goals; Home; Impairment; Incontinence; Individual; Injections; Lead; Lower Extremity; Lower urinary tract; Mediating; Modality; Motor; Multiple Sclerosis; Nerve; Nerve Fibers; Nervous System Trauma; Neurogenic Bladder; Neurologic; Neuronal Plasticity; Neurostimulation procedures of spinal cord tissue; Organ; Overactive Bladder; Paralysed; Parkinson Disease; Patients; Pharmaceutical Preparations; Phase; Physiologic pulse; Physiological; Placebos; Plant Roots; Play; Posterior Tibial Nerves; Procedures; Quality of life; Questionnaires; Randomized; Recovery; Recurrence; Reporting; Research; Research Design; Risk; Risk Management; Rogaine; Role; Safety; Sensory; Signal Transduction; Spinal; Spinal Cord; Spinal cord injury; Spinal cord injury patients; Stroke; Symptoms; Techniques; Technology; Testing; Time; Upper Extremity; Urinary Incontinence; Urinary tract infection; Urodynamics; Visit; Volition; Work; base; clinically significant; control trial; cost; design; experience; functional restoration; impression; improved; injured; micturition urgency; motor rehabilitation; neural circuit; neural network; neuroregulation; novel strategies; novel therapeutics; partial recovery; patient population; pressure; prevent; primary endpoint; primary outcome; prototype; recruit; relating to nervous system; restoration; side effect; urinary; validation studies; verification and validation; virtual

Summary Spinal cord injury invariably leads to severe dysfunction of the lower urinary tract; patients develop urinary incontinence, recurrent urinary tract infections, incomplete bladder emptying and high bladder pressures. Reliance on catheters to empty the bladder is virtually universal. Established therapies for lower urinary tract dysfunction due to spinal cord injury focus on preventing and managing complications rather than on restoring function. Relying on our years of experience in rehabilitation of motor function after paralysis, we are confident that we can change the paradigm of bladder care in individuals with spinal cord injuries as well. Transcutaneous Electrical Spinal Cord Neuromodulation (TESCoN) offers a diametrically different approach to classic therapies for neurogenic bladder: by delivering low-intensity sub-motor threshold electrical pulses to the spinal cord, TESCoN activates lumbar neural networks rendered dysfunctional by the spinal cord injury and restores some communication between the lower urinary tract and higher neural centers responsible for micturition control. Results from our preliminary studies indicate that TESCoN-mediated neuromodulation improves bladder capacity, diminishes urinary incontinence and, remarkably, restores bladder sensation even in individuals, whose spinal cord injury is considered clinically complete. In this Phase II application, we propose to build a commercial version of the TESCoN prototype under design controls and use the device in a clinical validation study. We propose a multicenter randomized control trial to demonstrate the beneficial effects of TESCoN on the paralyzed lower urinary tract. By recruiting sixty individuals with spinal cord injury and comparing the effects of sham and true stimulation on their lower urinary tract, we aim to show that TESCoN has a significant role in managing and rehabilitating urinary function in the clinical setting (primary outcome). The academic roots of our company and the team we have assembled (engineers, entrepreneurs and clinicians) ensure that our study design, implementation and analysis will be both impactful and rigorous. Successful completion of this study will provide evidence for a FDA 510(k) submission. Finally, if TESCoN is successful in the case of a neurological impairment as devastating as a spinal cord injury, we are confident that we will be able to bring this technology to a much larger population of patients suffering from lower urinary tract dysfunction due to both neurological and non-neurological conditions, such as stroke, multiple sclerosis, Parkinson’s disease and idiopathic overactive bladder.

概括 脊髓损伤总是导致下尿路严重功能障碍。患者出现尿 尿失禁，复发性尿路感染，不完整的膀胱排空和高膀胱压力。 依靠导管清空膀胱几乎是普遍的。较低尿路的已建立疗法 脊髓损伤引起的功能障碍专注于预防和管理并发症，而不是恢复 功能。依靠我们多年在麻痹后恢复运动功能的经验，我们有信心 我们也可以改变脊髓损伤患者的膀胱护理范例。经皮 电脊髓神经调节（TESCON）为经典疗法提供了截然不同的方法 对于神经源性膀胱：通过向脊髓传递低强度的亚运动阈值电脉冲， Tescon激活腰椎神经网络因脊髓损伤而使功能失调并恢复一些 较低尿路与负责排尿控制的高级神经元之间的通信。 我们的初步研究的结果表明，TESCON介导的神经调节可改善膀胱 能力，减少尿失禁，显着地恢复膀胱感，即使在个人中， 脊髓损伤被认为在临床上完成。 在此II阶段应用程序中，我们建议在下面建立Tescon原型的商业版本 设计控制并在临床验证研究中使用该设备。我们提出了一个多中心随机对照 试验证明了Tescon对瘫痪的下尿路的有益作用。通过招募六十 患有脊髓损伤的个体，并比较假和真实刺激对尿液的影响 区域，我们的目的是表明TESCON在管理和修复尿液功能中起着重要作用 临床环境（主要结果）。我们公司的学术根源和我们组装的团队 （工程师，企业家和临床医生）确保我们的研究设计，实施和分析将是 有影响力和严格。这项研究的成功完成将为FDA 510（k）提交提供证据。 最后，如果TESCON在神经系统损伤中像脊髓损伤一样成功，则 我们相信我们将能够将这项技术带给大量遭受的患者人群 由于神经系统和非神经学条件，例如中风， 多发性硬化症，帕金森氏病和特发性过度活跃的膀胱。