Transcutaneous electroacupuncture for gastroparesis

描述（由申请方提供）：胃轻瘫是一种常见疾病，定义为胃排空延迟。它存在于全球约1.5亿糖尿病患者中的至少20%中，并且存在于超过20%的功能性消化不良患者中，功能性消化不良影响约10%-25%的一般人群。胃轻瘫是一种难治性疾病，缺乏治疗选择。胃轻瘫的常见症状包括恶心、呕吐、早饱和腹胀。电针（EA）是一种结合针刺和电流刺激的方法，而不是手动操作针。本实验室最近的研究表明，电针或经皮电针（TEA）对胃动力障碍有治疗作用。已经观察到EA或TEA在胃排空以及消化不良症状方面的改善。本课题设计并研制了一种用于TEA治疗的微刺激器.微刺激器足够小，使得它可以附接到刺激电极旁边的皮肤上，因此患者可以在接受TEA治疗的同时恢复正常的日常活动。这不仅是有吸引力的，而且更有效，因为TEA可以更频繁地进行，持续时间更长。本探索性项目旨在研究胃轻瘫患者“无线”TEA的可行性，有效性和某些机制。首先，将研究长期使用拟议的微刺激器的可行性。其次，将在糖尿病或特发性胃轻瘫患者中采用双盲交叉设计研究TEA在改善胃排空延迟和胃轻瘫症状方面的功效。第三，将研究TEA引起胃轻瘫的可能机制。一个全面的团队已经组建起来进行这项研究，包括胃肠动力，中医和临床患者护理专家。

DESCRIPTION (provided by applicant): Gastroparesis is a common disease defined as delayed emptying of the stomach. It is present in at least 20% of about 150 million patients with diabetes worldwide and in more than 20% of patients with functional dyspepsia that affects about 10%-25% of the general population. Gastroparesis is a refractory disease with a lack of therapeutic options. Common symptoms of gastroparesis include nausea, vomiting, early satiety and abdominal bloating. Electroacupuncture (EA) is a combined procedure with acupuncture and electrical current stimulation instead of manual manipulations of the needles. Recent studies in our lab with EA or transcutaneous EA (TEA) have suggested a therapeutic role of EA or TEA for gastric motility disorders. Improvement has been observed with EA or TEA in gastric emptying as well as dyspeptic symptoms. In this project, a micro- stimulator is designed and developed for the TEA therapy. The micro-stimulator is small enough so that it can be attached to the skin next to the stimulation electrodes and therefore the patient can resume normal daily activity while being treated by TEA. This is not only attractive but also more effective since TEA can be performed more often and for longer durations. This exploratory project is designed to study the feasibility, efficacy and certain mechanisms of the proposed method of "wireless" TEA in patients with gastroparesis. Firstly the feasibility of the chronic use of the proposed micro-stimulator will be studied. Secondly, the efficacy of the TEA in improving delayed gastric emptying and symptoms of gastroparesis will be investigated in a double-blinded crossover design in patients with diabetic or idiopathic gastroparesis. Thirdly, possible mechanisms involving pathogeneses of gastroparesis with TEA will be investigated. A comprehensive team has been assembled to perform the study, including experts in gastrointestinal motility, traditional Chinese medicine and clinical patient care.