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，是肠易激综合征中最常见的症状 常见的胃肠道疾病，影响14-20%的美国人口。超过40%的IBS患者 经常使用阿片类麻醉剂。目前，IBS患者的疼痛尚无适当的治疗方法。 针灸或电针(EA)已被证明对疼痛治疗有效，并可能 阿片类药物危机治疗疼痛的潜力；然而，它的缺点是不经常给药，缺乏 方法优化，机制不清。在本研究中，我们提出了一种非侵入性的方法 经皮电刺激术(TEA)，用表面电极代替针头，选择一种 周围神经附近的穴位很少。建议的TEA是基于之前的一些基本 机制研究和临床研究。在方法论上，两套有效的刺激参数和 已有两个有效的穴位用于治疗内脏过敏。从机械上讲，适当的茶 已被证明可以改善IBS患者受损的自主神经功能。临床上，建议的茶叶可以 在家/单位自行给药，因此日常治疗是可行的，这大大提高了其疗效。 在UG3阶段，现有的TEA设备将被改装用于治疗IBS的慢性腹痛。 首先，将开发一款特殊的手机应用程序来记录每一次治疗的历史，这在 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 将这些信息(未识别)自动传输到服务器；这将最大限度地减少关键数据丢失或丢失 治疗结果信息，并将有助于未来的数据挖掘和治疗改进。其次，一个 将进行急性临床生理测试，以确定最佳刺激位置和参数。 在UH3阶段，将对160名IBS患者进行早期可行性临床研究。而当 主要目的是研究建议的TEA在治疗IBS腹痛方面的治疗潜力。 这项研究还旨在确定患者的亚组(轻度疼痛与中度疼痛；便秘与腹泻) 世卫组织可能会在未来的大规模临床研究中对茶有反应，并比较其止痛效果和自主神经 电神经调节疗法(TEA)与内科神经调节疗法的作用机制 (药理神经调节剂)。 已经组建了一个全面的团队，包括神经调节、腹痛、IBS、 设备开发和监管事务。该项目是一个强大的 管理内脏疼痛和IBS的学术中心，以及一家致力于将建议的 为患者和医院提供新的治疗方法。

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.