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

AccelBand，一种腿戴式经皮神经调节装置，用于治疗脊髓损伤患者的神经源性肠功能障碍

• 批准号: 10492922
• 负责人: Jiande Chen
• 金额: $ 60.87万
• 依托单位: TRANSTIMULATION RESEARCH, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-15 至 2025-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10492922
• 关键词: Acupuncture Points; Adverse event; Anatomy; Appearance; Ataxia; Brain Stem; Caring; Cell Nucleus; Cerebral Palsy; Chronic; Clinical; Clinical Research; Clinical Trials; Colon; Colorectal; Complication; Constipation; Consumption; Cutaneous; Defecation; Development; Device Designs; Device Safety; Devices; Disease; Electric Stimulation; Electrodes; Engineering; Enteral; External anal sphincter structure; Feces; Functional disorder; Goals; Home; Individual; Interneurons; Intestines; Joints; Leg; Lesion; Mediating; Medical; Michigan; Monitor; Motor; Motor Neurons; Multiple Sclerosis; Neurons; Outcome; Pathway interactions; Patients; Persons; Pharmaceutical Preparations; Pharmacotherapy; Pilot Projects; Plant Roots; Procedures; Quality of life; Randomized; Rehabilitation therapy; Research; Resort; Sacral nerve; Safety; Spinal cord injury; Stigmatization; Stroke; Texas; Therapeutic Effect; Time; Universities; arm; base; cell motility; chronic stroke; clinical efficacy; design; efficacy study; gastrointestinal symptom; hospital readmission; improved; laxative; nervous system disorder; neuroregulation; nondrug therapy; novel; primary outcome; product development; rectal; routine care; secondary outcome; smartphone Application; spinal pathway; synergism; targeted delivery; usability; wearable device

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.

概括 神经源性肠功能障碍（NBD）表现为结肠蠕动缓慢和便秘，是第二位肠功能障碍患者。 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 视为最重要的生活质量问题。 尽管缺乏临床试验支持，但 43% 的 SCI 患者服用泻药。此外，65% 的 SCI 患者服用泻药。 脊髓损伤患者诉诸于污名化、有损尊严、繁重且耗时的肠道护理 SCI 中由于中枢神经控制丧失而导致的 NBD 的主要病理生理学包括：1) 结肠传输时间延长，2）直肠敏感性低下，3）肛门直肠协同失调的进展。 尽管已测试了迫切的需求，但改善 NBD 的有效药物治疗进展缓慢。 我们已经针对 NBD 探索了非药物疗法，包括经皮神经调节 (TNM)。 临床研究，我们发现TNM应用于ST36穴位（膝盖骨以下）可以改善 NBD 通过加速结肠运输、改善中风、慢性便秘和其他疾病患者 直肠敏感性，恢复结肠 - 肛门外括约肌协同作用，通过 TNM 介导效应 骶副交感神经的激活从解剖学上讲，ST36 穴位位于皮肤。 直接刺激骶神经和神经根可改善 NBD。 SCI 在 4 项临床研究中，我们勇敢地承认 ST36 的 TNM 同样能够改善患者的 NBD 我们进一步探索 TNM 对结肠转运的治疗作用是通过 骶副交感神经通路以及恢复直肠敏感性和结肠-肛门外括约肌 协同作用——通过骶体途径。 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 ST36穴位放置在ST36穴位上治疗SCI和其他神经系统疾病的NBD。 该项目的主要任务是设计和开发一种易于使用的腿戴式 TNM 设备 AccelBand 并评估其 治疗 SCI 中 NBD 的临床潜力。