Home-based transcutaneous electrical acustimulation for abdominal pain

家庭经皮电针治疗腹痛

基本信息

批准号：
10619029
负责人：
Jiande Chen
金额：
$ 66.48万
依托单位：
UNIVERSITY OF MICHIGAN AT ANN ARBOR
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-09-30 至 2025-07-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10619029
关键词：
Abdominal Pain Acupuncture Points Acupuncture Therapy Acustimulation Acute Adult Affect Analgesics Animal Model Basic Science Clinical Clinical Data Clinical Research Clinical Trials Collaborations Constipation Country Data Development Device or Instrument Development Devices Diarrhea Electric Stimulation Electroacupuncture Electrodes Esthesia Financial cost Future Gastrointestinal Diseases Gastroparesis Grant Healthcare Heroin Home Hospitals Hypersensitivity Impairment Irritable Bowel Syndrome Location Medical Medical center Methodology Methods Morphine Narcotics Nausea and Vomiting Needles Neuromodulator Opioid Outcome Pain Pain management Patients Peripheral Nerves Pharmacology Phase Physicians Physiological Population Randomized Recording of previous events Regulatory Affairs Surface Symptoms Testing Therapeutic Time Treatment Efficacy Treatment Protocols Treatment outcome United States National Institutes of Health Visceral Visceral pain Work base chronic abdominal pain cloud platform compliance behavior computerized cost data mining design improved neuroregulation novel novel therapeutics opioid epidemic opioid use pain score patient health information patient population patient subsets pressure primary outcome recruit rectal remote monitoring research study side effect smartphone Application success therapy outcome

项目摘要

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.

腹痛是肠易激综合征（IBS）患者的主要症状，该综合征是最常见的肠易激综合征（IBS）患者的主要症状。影响 14-20% 美国人的常见胃肠道疾病。超过40%的IBS患者经常使用阿片类麻醉剂。目前还没有足够的疗法来治疗 IBS 患者的疼痛。针灸或电针 (EA) 已被证明对疼痛管理有效，并且可能具有治疗疼痛以应对阿片类药物危机的潜力；但其缺点是管理不频繁、缺乏方法论优化，机制不明确。在这项研究中，我们提出了一种非侵入性方法经皮电针刺激（TEA），通过用表面电极代替针头并选择周围神经附近的穴位很少。拟议的 TEA 基于之前的一些基本原则机制研究和临床研究。从方法上讲，两组有效的刺激参数和已衍生出两个治疗内脏过敏的有效穴位。从机制上讲，适当的 TEA 已被证明可以改善 IBS 受损的自主功能。临床上，所提出的 TEA 可以在家/工作中自行给药，日常治疗可行，大大提高了疗效。在 UG3 阶段，将对现有的 TEA 装置进行改造，用于治疗 IBS 慢性腹痛。首先，将开发一个特殊的手机应用程序 1) 保存每次治疗的历史记录，这对于评估治疗依从性，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信息，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获得最佳刺激位置和参数。在 UH3 阶段，将在 160 名 IBS 患者中进行早期可行性临床研究。虽然主要目的是研究所提出的 TEA 在治疗 IBS 腹痛方面的治疗潜力，研究还旨在确定患者亚组（轻度疼痛与中度疼痛；便秘与腹泻）谁可能对 TEA 做出反应以进行未来的大规模临床研究并比较镇痛效果和自主神经电神经调节疗法（TEA）和医学神经调节疗法之间的机制（药理学神经调节剂）。已经组建了一个综合团队，包括神经调节、腹痛、IBS、设备开发和监管事务。该项目是实力雄厚的公司之间密切合作的结果管理内脏疼痛和肠易激综合症的学术中心，以及一家致力于将拟议的为患者和医院提供新颖的疗法。