Effect of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) on Plasma Insulin Levels

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Indiana University
Study ID
NCT06597149
Status
Recruiting
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Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Transcutaneous Auricular Vagus Nerve Stimulation — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Apr 16, 2025
Status verified
Mar 2026
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

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 A 5 ml sample of blood is withdrawn.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.

Primary Outcome Measure

Association between acute transcutaneous auricular vagus nerve stimulation and change in plasma insulin levels [ Time Frame: one month ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Indiana University HospitalIndianapolisIndiana46202
Maureen Schilling, BS
[email protected]
317-278-2064
Thomas V Nowak, MD
[email protected]
3179484272

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By research site
Indiana University Hospital· Indianapolis, IN

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