Wearable Transcutaneous Electrical Acustimulation for Gastroparesis

可穿戴式经皮电针治疗胃轻瘫

• 批准号: 10266104
• 负责人: Jieyun None Yin
• 金额: $ 82.17万
• 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 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10266104
• 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; 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，定义为胃排空延迟并伴有相关症状。 在没有机械障碍的情况下出现症状。据报道，大约 25-30% 的患者出现这种情况 患有功能性消化不良，影响约 10-20% 的普通人群，其中 40% 1 型糖尿病的患病率。胃轻瘫是一种难治性疾病，缺乏治疗方法 选项。胃轻瘫的常见症状包括早饱、餐后饱胀、 恶心、呕吐、腹胀和上腹痛。 电针（EA）或针灸已被提议用于治疗功能性功能障碍 胃肠道疾病的基础和临床研究。经皮电 针刺法（TEA）是电针的改良版，具有非侵入性、家庭式等优点。 基础化运营、日常管理、成本低；它可以让患者维持日常 治疗不影响他/她的日常活动。在之前的临床前研究中，原型 该公司开发的 TEA 设备被证明可以改善患者的症状 糖尿病性胃轻瘫。 在当前的提案中，将设计和开发可穿戴式无线TEA设备 基于之前的原型设备。一次性粘性电极垫（5.5cm x 2.4cm x 0.2cm）和重量小于10g的卡扣式微刺激器将在 该项目的第一年。该设备将通过带有APP的智能手机进行无线控制 安装用于跟踪治疗依从性。研究 TEA 装置的效果 关于胃轻瘫的症状和主要病理生理学，一项随机、假手术对照 项目第二年将在 30 名糖尿病患者中进行临床研究 胃轻瘫分为两个治疗组：TEA 和假 TEA。每次治疗持续8 并行几周，然后进行为期 4 周的假 TEA（对于 TEA 组）或 TEA（对于 假茶组）。主要结果是胃轻瘫症状；次要的 结果将包括胃排空、生活质量症状和所有主要症状 胃轻瘫的病理生理学和自主机制。 已经组建了一个综合团队，包括神经调节领域的专家， 胃肠动力、胃轻瘫和设备开发。