Vagus Nerve Stimulation for Insulin Levels
(TaVNS Trial)

Recruiting in Palo Alto (17 mi)

Overseen byThomas V Nowak, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Indiana University

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?The purpose of this study is to find out if investigators can stimulate the vagus nerve (a nerve in the body that runs from your brain to the large intestine), and influence insulin, C-peptide, and glucose levels. C-peptide is a substance that is created when insulin is produced and released into the body. The vagus nerve is a largely internal nerve that controls many bodily functions, including stomach function. Investigators hope that by stimulating the vagal nerve using the TeNS behind the ear, this stimulation can affect insulin levels, and this will help innovate treatment of patients with nausea, vomiting, and disordered stomach function, and patients with diabetes. Researchers hope to be able to measure the activity of the vagus nerve when it is stimulated in other ways. This could help investigators learn more about studying this nerve in the future.

Eligibility Criteria

This trial is for healthy individuals interested in participating in a study that investigates the effects of stimulating a nerve related to many bodily functions on insulin and blood sugar levels.

Inclusion Criteria

I am willing to have electrodes placed on my ear.

I am a healthy volunteer between 18 and 70 years old.

I am willing to have ECG electrodes placed on my neck and chest.

+1 more

Exclusion Criteria

I do not want the taVNS device in my ear.

I have been diagnosed with diabetes.

Unwilling to consent to a blood draw

+6 more

Participant Groups

The study tests if Transcutaneous Auricular Vagus Nerve Stimulation (taVNS), which is non-invasive stimulation behind the ear, can influence insulin, C-peptide, and glucose levels in the body.

1Treatment groups

Experimental Treatment

Group I: StimulationExperimental Treatment1 Intervention

Subjects are placed supine, ECG electrodes are applied, a butterfly catheter is inserted into a peripheral vein. A 5 ml sample of blood is withdrawn. A TENS device is placed on the cutaneous branch of the auricular branch of the vagus nerve. After a twenty-minute baseline reading, the TENS unit is then turned ON and electrical stimuli are delivered over 40 minutes. A second sample of blood representing the experimental period is drawn at the end of the 40 minutes. The TENS device is then turned to the OFF positon and after twenty minutes a third and final sample of blood is drawn.

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) is already approved in United States, European Union, China for the following indications:

🇺🇸 Approved in United States as Transcutaneous Auricular Vagus Nerve Stimulation for: