Recruiting

Vagus Nerve Stimulation

Sponsor:

Indiana University

Code:

NCT06597149

Conditions

Healthy

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Interventions

Transcutaneous Auricular Vagus Nerve Stimulation

Study Details

Brief summary:

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.

Conditions

Healthy

Study ID

NCT06597149

Start date

Apr 16, 2025

Status verified date

Mar, 2026

Completion date

May 31, 2028

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

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. alpha or beta blockers for hypertension.
  • Pregnant females
  • Those unwilling to have the taVNS device placed in their ear.
  • Those unwilling to consent to a blood draw.
  • Prisoners

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Stimulation

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.

Interventions

Transcutaneous Auricular Vagus Nerve Stimulation

Healthy adult participants will be assigned to either the stimulation group or the sham group. The stimulation group will receive mild stimulation from the TeNS device and the sham group will receive no stimulation but will believe that they are receiving stimulus.

Primary outcome measure

  • Association between acute transcutaneous auricular vagus nerve stimulation and change in plasma insulin levels [ Time Frame: one month ]
  • Association between acute transcutaneous auricular vagus nerve stimulation and change in C-peptide levels [ Time Frame: one month ]
  • Association between acute transcutaneous auricular vagus nerve stimulation and change in glucose levels [ Time Frame: one month ]
  • Association between acute transcutaneous auricular vagus nerve stimulation and heart rate variability [ Time Frame: one month ]
  • Association between changes in heart rate variability and plasma insulin levels [ Time Frame: one month ]
  • Association between changes in heart rate variability and C-peptide levels [ Time Frame: one month ]
  • Association between changes in heart rate variability and glucose levels [ Time Frame: one month ]

Central Contacts and Locations

Central contacts

Maureen Schilling, BS

3172782064maschi@iu.edu

Locations

Indiana University Hospital

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Maureen Schilling, BS

317-278-2064maschi@iu.edu

Thomas V Nowak, MD

3179484272tvnowak@iu.edu

More Information

Sponsor

Indiana University

Last update posted

Aug 26, 2026

Last verified

Mar, 2026

Keywords

  • Healthy
  • Individual

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Indiana University on 2026-08-26.