The purpose of this study is to find out if we can stimulate the vagus nerve. The vagus nerve is a largely internal nerve that controls many bodily functions, including stomach function. We hope that electrically stimulating the nerve around the external ear will also stimulate the internal vagus nerve. If it does, then we hope that this will help our treatment of patients with nausea and vomiting and disordered stomach function.
Wiling to have one teaspoon (5 ml) of blood drawn.
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.
Unable to provide consent
Pregnant females
Medical records indicate intestinal pseudo-obstruction
Diagnosed with cardiac arrhythmia
Parallel
PERCUTANEOUS ELECTRICAL FIELD NERVE STIMULATION
DeviceThe 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 percutaneous electrical nerve field stimulation
DeviceSHAM (no electrical charge)
Change in Gastroparesis Cardinal Symptom Index Daily Dairy
ANMS GASTROPARESIS CARDINAL SYMPTOM INDEX - DAILY DIARY this tool uses a list of 7 criteria for rating gastric symptoms. The scale ratings are: None, Mild, Moderate, Severe, and Very Severe.
Change in Patient Assessment of Upper Gastrointestinal Disorder Symptoms
Scores are calculated by averaging the scores for each item in the subscale, with scores ranging from 0 (none or absent) to 5 (very severe). Optimal outcome would be a score of zero, no episodes/symptoms.
Change in Heart Rate Variability
Heart Rate Variability is reported on a 0-100 scale.
Change in Anxiety
The General Anxiety Disorder (GAD)-7 scale is from 0-21, where 0= no anxiety and 21=severe anxiety
Change in the measure of depression
Patient Health Questionnaire (PHQ)-8 is a questionnaire that measures self-reported depressive systems. PHQ-8 uses a range from 0-24, where 0=no depressive symptoms and 24=severe symptoms.
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