RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-05-01
Study Completion:2027-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06597149

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Healthy Volunteers
  2. * Aged 18-70
  3. * Willing to have ECG electrodes placed on their neck and chest areas.
  4. * Willing to have electrodes placed in the external ear.
  5. * Willing to have an indwelling catheter placed to avoid multiple sticks for blood draw.
  1. * Unable to provide consent.
  2. * Diabetes diagnosis per patient report
  3. * Having known allergies to adhesive on electrode pads or bandages
  4. * Self -report of diagnosis of gastric motility issues
  5. * Taking any medications that may affect gastric motility or cardiac variability, i.e. alpha or beta blockers for hypertension.
  6. * Pregnant females
  7. * Those unwilling to have the taVNS device placed in their ear.
  8. * Those unwilling to consent to a blood draw.
  9. * Prisoners

Contacts and Locations

Study Contact

Maureen Schilling, BS
CONTACT
3172782064
maschi@iu.edu

Principal Investigator

Thomas V Nowak, MD
PRINCIPAL_INVESTIGATOR
IU Medical Scool

Study Locations (Sites)

Indiana University Hospital
Indianapolis, Indiana, 46202
United States

Collaborators and Investigators

Sponsor: Indiana University

  • Thomas V Nowak, MD, PRINCIPAL_INVESTIGATOR, IU Medical Scool

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-01
Study Completion Date2027-05

Study Record Updates

Study Start Date2025-05-01
Study Completion Date2027-05

Terms related to this study

Keywords Provided by Researchers

  • Healthy
  • Individual

Additional Relevant MeSH Terms

  • Healthy