Home-based transcutaneous electrical acustimulation for abdominal pain

腹痛是肠易激综合征（IBS）患者的主要症状， 常见的胃肠道疾病，影响14-20%的美国人口。超过40%的IBS患者 经常使用阿片类药物。目前没有足够的治疗方法可用于IBS患者的疼痛。 针灸或电针（EA）已被证明是有效的疼痛管理，并可能有 治疗阿片样物质危机的疼痛的潜力;然而，它具有不频繁给药、缺乏 方法优化和机制不明确。在这项研究中，我们提出了一种非侵入性的方法， 经皮电刺激（TEA），通过用表面电极代替针，并通过选择一个 周围神经附近的几个穴位。拟议的TEA是基于一些以前的基本 机制研究和临床研究。在方法学上，两组有效的刺激参数和 已推导出治疗内脏高敏感性的两个有效穴位。机械地，适当的TEA 已被证明可以改善IBS中受损的自主神经功能。在临床上，建议的TEA可以 在家中/工作中自我给药，因此每日治疗是可行的，这大大提高了其疗效。 在UG 3阶段，将对现有的TEA装置进行改良，用于治疗IBS中的慢性腹痛。 首先，将开发一个特殊的手机应用程序1）以保存每次治疗的历史，这对于 评估治疗依从性，以及2）每天和每周收集和存储主要治疗结果，以及 自动将这些信息（去识别化）传输到服务器;这将最大限度地减少关键信息的丢失或丢失 治疗结果的信息，并将有助于未来的数据挖掘和治疗完善。其次 将进行急性临床生理测试，以获得最佳刺激位置和参数。 在UH 3阶段，将在160例IBS患者中进行早期可行性临床研究。而 主要目的是研究所提出的TEA在治疗IBS腹痛中的治疗潜力， 研究还旨在确定患者亚组（轻度疼痛vs.中度疼痛;便秘vs.腹泻） 可能对TEA有反应的患者进行大规模临床研究，并比较TEA的镇痛效果和自主神经功能。 电神经调节治疗（TEA）和药物神经调节治疗之间的机制 （药理学神经调节剂）。 一个全面的团队已经组建，包括神经调节，腹痛，IBS， 器械开发和法规事务。该项目是一个强大的 管理内脏疼痛和IBS的学术中心，以及一家致力于将拟议的 为患者和医院提供新疗法。

Abdominal pain is the main symptom in patients with the irritable bowel syndrome (IBS) that is the most common gastrointestinal disorder affecting 14-20% of the US population. More than 40% of patients with IBS regularly use opioid narcotics. Currently no adequate therapies are available for pain in patients with IBS. Acupuncture or electroacupuncture (EA) has been shown to be effective for pain management and may have a potential for treating pain against opioid crisis; however, it has drawbacks of infrequent administration, lack of optimization in methodology and unclear mechanisms. In this study, we propose a noninvasive method of transcutaneous electrical acustimulation (TEA) by replacing needles with surface electrodes and by choosing a few acupoints in the vicinity of peripheral nerves. The proposed TEA is based on a number of previous basic mechanistic researches and clinical studies. Methodologically, two effective sets of stimulation parameters and two effective acupoints have been derived for treating visceral hypersensitivity. Mechanistically, appropriate TEA has been shown to improve autonomic functions that are impaired in IBS. Clinically, the proposed TEA can be self-administrated at home/work and therefore daily treatment is feasible, which greatly improves its efficacy. During the UG3 phase, an existing TEA device will be modified for treating chronic abdominal pain in IBS. First, a special cellphone app will be developed 1) to keep a history of each treatment, which is critical in assessing therapy compliance, and 2) to collect and store major treatment outcomes daily and weekly, and transit these information (de-identified) to a server automatically; this will minimize missing or loss of critical treatment outcome information and will be useful for future data mining and therapy refinement. Secondly, an acute clinical physiological test will be performed to derive best stimulation locations and parameters. During the UH3 phase, an early feasibility clinical study will be performed in 160 patients with IBS. While the primary aim is to investigate the therapeutic potential of the proposed TEA in treating abdominal pain in IBS, the study is also designed to identify subgroups of patients (mild pain vs. moderate pain; constipation vs. diarrhea) who may respond to TEA for a future large scale clinical study and to compare the analgesic effect and autonomic mechanisms between the electrical neuromodulation therapy (TEA) and a medical neuromodulation therapy (pharmacological neuromodulators). A comprehensive team has been assembled, including experts in neuromodulation, abdominal pain, IBS, device development and regulatory affairs. The project results from a close collaboration between a strong academic center in managing visceral pain and IBS, and a start-up company devoted to bringing the proposed novel therapy to patients and hospitals.