Wearable Transcutaneous Electrical Acustimulation for Gastroparesis

胃轻瘫是一种常见的疾病，定义为胃排空延迟并与 在没有机械障碍的情况下出现症状。据报道，大约有25%-30%的患者患有这种疾病 患有功能性消化不良，约占总人口的10%-20%，其中40% 1型糖尿病的患病率。胃瘫是一种难治性疾病，缺乏治疗手段。 选择。胃瘫的常见症状包括早饱、餐后饱、 恶心、呕吐、腹胀和上腹部疼痛。 电针(EA)或针灸已被提出用于治疗功能性 胃肠道疾病的基础和临床研究。经皮电 声刺激(TEA)是电针的一种改进型，具有非侵入性、家族性等优点。 以手术为基础，每日给药，成本低，可使患者维持日常生活 在不影响其日常活动的情况下接受治疗。在之前的一项临床前研究中，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的无线TEA设备 基于之前的原型装置。一次性粘合电极垫(5.5 cm x 2.4 cm x 0.2厘米)，并将开发重量小于10g的卡扣式微刺激器 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 安装后可跟踪记录治疗依从性。为了调查茶具的效果 胃轻瘫症状与主要病理生理的随机对照研究 在该项目的第二年，将对30名糖尿病患者进行临床研究 胃轻瘫分为两个治疗组：茶组和假茶组。每次治疗将持续8次 两周平行，然后是4周的假茶(对于茶组)或茶(对于 假茶组)。主要结果是胃瘫症状；次要结果是 结果将包括胃排空，生活质量症状和所有主要 胃轻瘫的病理生理学和自主神经机制。 已经组建了一个全面的团队，包括神经调节方面的专家， 胃肠动力、胃轻瘫和设备开发。

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.