Effect of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) on Plasma Insulin Levels
Indiana University
Summary
The vagus or vagal nerve is a nerve that sends signals from the brain to other parts of the body to control involuntary functionm, including stomach function, and it is important to the regulation of insulin, C-peptide, and glucose levels. The purpose of this study is to evaluate whether electrically stimulating the nerve around the external ear will also stimulate the internal vagus nerve and influence the levels of insulin, C-peptide, and glucose. If it does, investigators hope that this will help innovate treatment of patients with nausea, vomiting, and disordered stomach function, and patients with diabetes.
Description
Healthy volunteer subjects will be recruited for this project, which will be completed at a up to 2 study visits. Prior to each visit, participants will be asked not to eat or drink anything (except a small amount of water to take medications) for 8-10 hours. When participants arrive to Study Visit 1, they will be asked to lie in a supine position and will be fitted with: * ECG electrodes, placed on the chest, arms/legs for electrocardiogram (ECG) recordings and behind each ear and just below the jaw on each side to record vagal nerve activity * a butterfly needle catether for blood sample…
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Healthy Volunteers * Aged 18-70 * Willing to have ECG electrodes placed on their neck and chest areas. * Willing to have electrodes placed in the external ear. * Willing to have an indwelling catheter placed to avoid multiple sticks for blood draw. Exclusion Criteria: * Unable to provide consent. * Diabetes diagnosis per patient report * Having known allergies to adhesive on electrode pads or bandages * Having gastric motility issues as determined by the PI or clinical coordinator. * Taking any medications that may affect gastric motility or cardiac variability, i.e. a…
Interventions
- DeviceTranscutaneous Auricular Vagus Nerve Stimulation
For participants in the active stimulation group, electrical stimuli are delivered continuously for 40 minutes at a pulse width of 300 microseconds, pulse frequency of 25 Hz, and pulse amplitude of 0.5 to 1.5 mA based on the tolerance of the patient. Stimuli current and frequency may be decreased, if necessary, to minimize participant discomfort.
- DeviceSham Procedure (No Stimulation)
The TENS device will be placed but not turned on.
Location
- Indiana University HospitalIndianapolis, Indiana