Wearable Transcutaneous Electrical Acustimulation for Gastroparesis

可穿戴式经皮电针治疗胃轻瘫

• 批准号: 10080439
• 负责人: Jieyun None Yin
• 金额: $ 61.84万
• 依托单位: TRANSTIMULATION RESEARCH, INC.
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-21 至 2022-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10080439
• 关键词: Abdominal Pain; Acupuncture Points; Acupuncture Therapy; Acustimulation; Address; Adhesives; Affect; Anxiety; Area; Basic Science; Cellular Phone; Chronic; Clinical; Clinical Research; Clinical Trials; Constipation; Data; Development; Device or Instrument Development; Devices; Diarrhea; Disease; Dyspepsia; Effectiveness; Electric Stimulation; Electroacupuncture; Electrodes; Functional Gastrointestinal Disorders; Functional disorder; Funding; Gastric Emptying; Gastroesophageal reflux disease; Gastrointestinal Diseases; Gastrointestinal Motility; Gastroparesis; General Population; Home environment; Insulin-Dependent Diabetes Mellitus; Irritable Bowel Syndrome; Location; Mechanics; Methods; Metoclopramide; Modification; Nausea and Vomiting; Obstruction; PC6 extract; Patients; Phase; Prevalence; Quality of life; Questionnaires; Randomized; Refractory Disease; Reporting; Research; Stomach; Symptoms; Therapeutic; United States National Institutes of Health; Wireless Technology; Workplace; Wrist; alpha-SNAP; associated symptom; base; cell motility; common symptom; cost; depressive symptoms; design; diabetic gastroparesis; diaries; digital; early satiety; effective therapy; improved; indexing; innovation; median nerve; neuroregulation; novel; operation; peroneal nerve; postoperative recovery; preclinical study; primary outcome; prototype; secondary outcome; symptomatic improvement; treatment group

Gastroparesis is a common disease defined as delayed gastric emptying with associated symptoms in the absence of mechanical obstructions. It is reported in about 25-30% of patients with functional dyspepsia and affects about 10-20% of general population, including 40% prevalence in type 1 diabetes. Gastroparesis is a refractory disease with a lack of therapeutic options. Common symptoms of gastroparesis include early satiety, postprandial fullness, nausea, vomiting, bloating and upper abdominal pain. Electroacupuncture (EA) or acupuncture has been proposed to treat functional gastrointestinal disorders in both basic and clinical researches. Transcutaneous electric acustimulation (TEA) is a modification of EA with the advantages of non-invasiveness, home- based operation, daily administration and low cost; it allows the patients to maintain the daily treatment without affecting his/her daily activity. In a previous preclinical study, the prototype TEA device developed by the company was shown to improve symptoms in patients with diabetic gastroparesis. In the current proposal, a wearable and wireless TEA device will be designed and developed based on the previous prototype device. A disposable adhesive electrode pad (5.5cm x 2.4cm x 0.2cm) and a snapped-on micro-stimulator weighing less than 10g will be developed during the first year of the project. The device will be controlled wirelessly via a smartphone with APP installed to track-record of therapeutic compliance. To investigate the effects of the TEA device on symptoms and major pathophysiologies of gastroparesis, a randomized, sham-controlled clinical study will be performed during the second year of the project in 30 patients with diabetic gastroparesis divided in to two treatment groups: TEA and sham-TEA. Each treatment will last 8 weeks in parallel followed by 4-week either sham-TEA (for the TEA group) or TEA (for the sham-TEA group). The primary outcomes will be gastroparesis symptoms; the secondary outcomes will include gastric emptying, the quality of life symptoms and all major pathophysiologies of gastroparesis and autonomic mechanisms. A comprehensive team has been assembled, including experts in neuromodulation, gastrointestinal motility, gastroparesis, and device development.

胃轻瘫是一种常见疾病，定义为胃排空延迟 在没有机械障碍的情况下症状。据报道约有25-30％的患者 功能性消化不良，影响约10-20％的普通人群，其中40％ 1型糖尿病患病率。胃轻瘫是一种难治性疾病，缺乏治疗性 选项。胃轻瘫的常见症状包括早期饱腹感，餐后饱满度， 恶心，呕吐，腹胀和上腹痛。 已经提出了电针（EA）或针灸来治疗功能 基础研究和临床研究中的胃肠道疾病。经性电力 刺激（茶）是对EA的修改，具有非侵入性，家庭的优势 基于运营，日常管理和低成本；它允许患者每天维护 治疗而不会影响他/她的日常活动。在先前的临床前研究中 该公司开发的茶具已被证明可以改善患者的症状 糖尿病性胃轻瘫。 在当前的建议中，将设计和开发可穿戴和无线茶设备 基于先前的原型设备。一次性粘合电极垫（5.5厘米x 2.4厘米x 0.2厘米）和重量少于10克的折断微型刺激器将在此期间开发 项目的第一年。该设备将通过带有应用的智能手机无线控制 安装以跟踪治疗合规性。调查茶设备的影响 关于胃轻瘫的症状和主要病理生理学，一种随机，假控制 临床研究将在该项目的第二年进行30例糖尿病患者 胃轻瘫分为两个治疗组：茶和假茶。每种治疗将持续8 平行数周，然后进行4周的假茶（用于茶组）或茶（用于 假茶组）。主要结果将是胃轻瘫症状；次要 结果将包括胃排空，生活质量症状和所有主要 胃轻瘫和自主机制的病理生理。 一支综合团队已经组建了，包括神经调节专家 胃肠道运动，胃轻瘫和装置开发。