Wearable Transcutaneous Electrical Acustimulation for Gastroparesis

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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.