Indiana University
The purpose of this study is to evaluate whether stimulation of the vagus nerve can improve nausea and vomiting in diabetic gastroparetic patients.
The vagus nerve is one of the main determinants of gastrointestinal motility and gastric emptying. It has been speculated that neuropathy of the vagus nerve is the cause of the delay in gastric emptying in gastroparesis, the symptoms of which include nausea, vomiting, weight loss, early satiety, abdominal pain and bloating. Percutaneous Electrical Nerve Field Stimulation (PENFS) has been approved by the FDA to treat adolescents with functional abdominal pain associated with irritable bowel syndrome. In this study, the impact of PENFS on gastroparesis symptoms will be evaluated. After informe…
Inclusion Criteria: * Wiling to have one teaspoon (5 ml) of blood drawn. * Willing to have electrodes placed in the external ear. * Diagnosed with gastroparesis for twelve months or longer * Diagnosed with diabetes either Type 1 or Type 2 * Documented delayed gastric emptying (\>10% retention of the test meal at four hours) on a standardized scrambled-egg scintigraphy gastric emptying test performed in the last two years. * Upper GI endoscopy indicating no mechanical obstruction performed in the last five years. * Symptoms of nausea and vomiting consistent with clinical diagnosis of gastropar…
The IB-Stim is a percutaneous electrical nerve field stimulator (PENFS) system intended to be used in patients 11-18 years of age with functional abdominal pain associated with irritable bowel syndrome (IBS). The IB-Stim is intended to be used for 120 hours per week up to 3 consecutive weeks, through application to branches of Cranial Nerves V, VII, IX and X, and the occipital nerves identified by transillumination, as an aid in the reduction of pain when combined with other therapies for IBS.
SHAM (no electrical charge)
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