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.

总结 神经源性肠功能障碍（Neurogenic bowel dysfunction，NBD）是以结肠运动缓慢和便秘为主要表现的肠道疾病，在肠功能障碍中居第二位 脊髓损伤患者最常见的并发症和第四大最常见的再次住院原因 （SCI）。超过1/3的SCI患者认为NBD是最重要的生活质量问题。为了治疗NBD， 43%的SCI患者服用泻药，尽管缺乏支持其使用的临床试验。此外，65%的 SCI患者诉诸于使用污名化的、不体面的、繁重的和耗时的肠道护理 程序.由于中枢神经控制的丧失而导致的SCI中NBD的关键病理生理学包括：1） 结肠传输延长，2）直肠敏感性降低，和3）肛门直肠协同失调。的成就 用于改善NBD的有效药物治疗一直进展缓慢，尽管迫切的需求未得到满足。因此，委员会认为， 已经探索了用于NBD的非药物疗法，包括经皮神经调节（TNM）。在我们 临床研究中，我们发现，TNM应用在穴位ST 36（膝盖骨以下）改善 NBD在中风、慢性便秘等疾病患者中通过加速结肠运输，改善 直肠敏感性和恢复结肠-肛门外括约肌协同作用，TNM效应通过 骶骨副交感神经激活在解剖学上，ST 36穴位位于皮肤 骶神经的末梢由于直接刺激骶神经和神经根可以改善NBD， 在4项临床研究中，我们假设ST 36的TNM同样能够改善患者的NBD 关于SCI我们进一步假设，TNM对结肠运输的治疗作用将通过以下途径介导： 骶副交感神经通路和恢复直肠敏感性和结肠-肛门外括约肌 协同作用-通过骶骨躯体通路。 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 用于治疗脊髓损伤和其他神经系统疾病中的NBD。具体目标 本项目的主要目的是设计和开发一种易于使用的腿戴式TNM设备，并评估其 治疗SCI中NBD的临床潜力。