AccelBand, a leg-worn transcutaneous neuromodulation device for treating neurogenic bowel dysfunction in individuals with spinal cord injury

摘要 神经原性肠功能障碍(NBD)表现为结肠运动缓慢和便秘，是第二位。 脊髓损伤患者最常见的并发症和再次住院的第四大常见原因 (SCI)。超过1/3的SCI患者将NBD列为最重要的生活质量问题。为了治疗NBD， 43%的脊髓损伤患者服用泻药，尽管缺乏临床试验支持他们的使用。此外，65%的 患有脊髓损伤的人求助于污名化、有损尊严、繁重和耗时的肠道护理 程序。中枢神经控制丧失所致脊髓损伤中NBD的主要病理生理机制包括：1) 结肠传输时间延长，2)直肠感觉减退，3)肛门直肠协同功能障碍。发展中的进步 尽管存在迫切的未得到满足的需求，但改善NBD的有效药物治疗一直进展缓慢。因此， 非药物疗法，包括经皮神经调节(TNM)，已经被探索用于NBD。在我们的 临床研究中，我们发现在穴位ST36(膝盖骨以下)应用TNM有改善作用 NBD对中风、慢性便秘等疾病患者结肠转运的促进作用，改善 直肠敏感性，恢复结肠-肛门外括约肌的协同作用，TNM效应通过 激活骶骨副交感神经。从解剖学上讲，ST36穴位位于皮肤 骶神经末梢。由于直接刺激骶神经和神经根显示出改善后的NBD SCI在4项临床研究中，我们假设ST36的TNM同样能够改善患者的NBD 和SCI一起。我们进一步假设，TNM对结肠运输的治疗作用可能是通过 骶骨副交感神经通路及其对直肠敏感性和结肠-肛外括约肌恢复的影响 协同作用--通过骶骨躯体途径。 该项目的长期目标是开发一种使用可穿戴设备的新型非侵入性TNM疗法 穴位放置于ST36穴治疗脊髓损伤后的NBD及其他神经系统疾病。具体目标 本项目的主要目的是设计和开发一种简单易用的腿式TNM设备AccelBand，并对其进行评估 脊髓损伤后NBD的临床治疗潜力。

SUMMARY Neurogenic bowel dysfunction (NBD) is manifested as a slow colonic motility and constipation, and it is the 2nd most common complication and 4th most common reason for re-hospitalization in people with spinal cord injury (SCI). More than 1/3 of people with SCI rate NBD as the most significant quality of life issue. To treat NBD, 43% of SCI individuals take laxatives despite the lack of clinical trials supporting their use. In addition, 65% of people with SCI resort to using stigmatizing, undignified, burdensome, and time-consuming bowel care procedures. Key pathophysiologies of NBD in SCI resulting from a loss of central neural control include: 1) prolonged colonic transit, 2) rectal hyposensitivity, and 3) anorectal dyssynergia. Progress in developing effective drug treatments for improving NBD has been slow, despite an urgent unmet need. Consequently, non-drug therapies, including transcutaneous neuromodulation (TNM), are have been explored for NBD. In our clinical studies, we discovered that TNM applied at the acupuncture point ST36 (below the kneecap) improves NBD in patients with stroke, chronic constipation, and other disorders by accelerating colonic transit, improving rectal sensitivity, and restoring colon - external anal sphincter synergy, with TNM effects mediated via the sacral parasympathetic activation. Anatomically, the ST36 acupuncture point is located at the cutaneous endings of the sacral nerves. Since direct stimulation of the sacral nerve and roots shown to improve NBD after SCI in 4 clinical studies, we hypothesize that TNM at ST36 is similarly capable of improving NBD in patients with SCI. We further hypothesize that therapeutic effects of TNM on the colonic transit would be mediated via the sacral parasympathetic pathway and on restoring the rectal sensitivity and colon - external anal sphincter synergy – via the sacral somatic pathway. The long-term goal of this project is to develop a novel noninvasive TNM therapy using a wearable device placed on ST36 acupuncture point for treating NBD in SCI and other neurological disorders. The specific aims of this project are to design and develop an easy-to-use leg-worn TNM device AccelBand and to evaluate its clinical potential in treating NBD in SCI.