Wearable Transcutaneous Electrical Acustimulation for Gastroparesis

胃轻瘫是一种常见的疾病，定义为胃排空延迟， 在没有机械障碍的情况下出现症状。据报道，约25-30%的患者 患有功能性消化不良，影响约10-20%的一般人群，包括40% 1型糖尿病的发病率。胃轻瘫是一种难治性疾病， 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）或针灸已被提出来治疗功能性 胃肠道疾病的基础和临床研究。经皮电 电刺激（TEA）是一种改良的EA，具有非侵入性，家庭， 基于操作，日常管理和低成本;它允许患者维持日常 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， 糖尿病胃轻瘫 在目前的提案中，将设计和开发一种可穿戴和无线TEA设备 基于先前的原型设备。一次性粘性电极垫（5.5cm x 2.4cm x 2.4cm） 0.2cm）和重量小于10 g的卡扣式微刺激器将在 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 用于跟踪记录治疗依从性。为了研究TEA装置的影响， 对胃轻瘫的症状和主要病理生理学的影响， 临床研究将在项目的第二年在30名糖尿病患者中进行 胃轻瘫分为两个治疗组：TEA和假TEA。每次治疗将持续8 周，然后是4周的假TEA（对于TEA组）或TEA（对于 假TEA组）。主要结局是胃轻瘫症状;次要结局是胃轻瘫症状。 结果将包括胃排空，生活质量症状和所有主要的 胃轻瘫的病理生理学和自主机制。 一个全面的团队已经组建，包括神经调节专家， 胃肠动力、胃轻瘫和器械开发。

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.