Effect Of Percutaneous Electrical Nerve Field Stimulation on Symptom Control/Nervous System Activity in Patients w/Diabetes Types 1/2

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorIndiana University

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

Unable to provide consent

Pregnant females

Medical records indicate intestinal pseudo-obstruction

Diagnosed with cardiac arrhythmia

Trial design

Treatments tested in this trial

  • PERCUTANEOUS ELECTRICAL FIELD NERVE STIMULATION
  • Sham percutaneous electrical nerve field stimulation

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators