Gentle ear vagus nerve stimulation to change insulin and blood sugar levels
Effect of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) on Plasma Insulin Levels
This project will test whether mild electrical stimulation of the vagus nerve at the ear can change insulin, C-peptide, and glucose levels in healthy adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Indiana University Academic / other |
| Locations | 1 site (Indianapolis, Indiana) |
| Trial ID | NCT06597149 on ClinicalTrials.gov |
What this trial studies
Healthy volunteers aged 18–70 will receive transcutaneous auricular vagus nerve stimulation (taVNS) via electrodes placed on the external ear while ECG leads and an indwelling catheter record physiological and blood responses. Investigators will measure plasma insulin, C-peptide, and glucose before and after stimulation to determine any acute changes. Secondary analyses will explore whether age, sex, or BMI influence the response. Findings will guide whether ear-based vagus stimulation should be tested later in patients with gastroparesis, nausea/vomiting, or metabolic disorders.
Who should consider this trial
Good fit: Healthy adults aged 18–70 who are willing to have ear electrodes, ECG leads, and an indwelling catheter for blood draws, and who do not have diabetes, pregnancy, adhesive allergies, or medications affecting gastric motility or cardiac variability.
Not a fit: People with diagnosed diabetes, gastric motility disorders, pregnant women, those on certain cardiac or motility medications, those with adhesive allergies, or anyone unwilling to undergo ear stimulation or blood draws are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this noninvasive approach could provide a way to influence insulin and glucose levels and potentially lead to new treatments for gastroparesis symptoms or aspects of diabetes.
How similar studies have performed: Previous work with percutaneous electrical nerve field stimulation and some taVNS studies has shown autonomic effects, but evidence that ear stimulation reliably alters insulin or glucose is preliminary and not yet established.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Indianapolis, Indiana
- Indiana University Hospital — Indianapolis, Indiana, United States (Recruiting)
Study contacts
- Principal investigator: Thomas V Nowak, MD — IU Medical Scool
- Study coordinator: Maureen Schilling, BS
- Email: maschi@iu.edu
- Phone: 3172782064
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.