Vagus Nerve Stimulation for Insulin Levels
(TaVNS Trial)
Trial Summary
Will I have to stop taking my current medications?
Yes, if you are taking medications that affect stomach movement or heart rate, like alpha or beta blockers, you will need to stop taking them to participate in this trial.
What data supports the effectiveness of the treatment Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for insulin levels?
Research shows that taVNS can lower post-meal levels of ghrelin, a hormone that stimulates appetite, which might help with weight loss and improve glucose tolerance. Additionally, studies in rats suggest taVNS may help regulate blood sugar and improve insulin receptor expression, although more research is needed to confirm these effects in humans.12345
Is transcutaneous auricular vagus nerve stimulation (taVNS) safe for humans?
How is the treatment taVNS different from other treatments for insulin levels?
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) is unique because it is a non-invasive, non-surgical method that stimulates the vagus nerve through the ear to potentially improve insulin levels and glucose tolerance. Unlike traditional treatments, taVNS is inexpensive, portable, and does not require medication, making it a novel approach for managing insulin-related conditions.123910
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.
Research Team
Thomas V Nowak, MD
Principal Investigator
IU Medical Scool
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Baseline Measurement
Participants undergo baseline measurements including ECG and blood sample collection before stimulation
Stimulation
Participants receive transcutaneous auricular vagus nerve stimulation for 40 minutes, followed by blood sample collection
Post-Stimulation Observation
Participants are observed for 20 minutes post-stimulation, and a final blood sample is collected
Follow-up
Participants are monitored for changes in plasma insulin, C-peptide, glucose levels, and heart rate variability over one month
Treatment Details
Interventions
- Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) is already approved in United States, European Union, China for the following indications:
- Post-stroke pain management
- Upper limb rehabilitation post-stroke
- Epilepsy
- Depression
- Tinnitus
- Post-stroke upper limb function improvement
- Stroke rehabilitation
- Upper limb functional restoration post-stroke
Find a Clinic Near You
Who Is Running the Clinical Trial?
Indiana University
Lead Sponsor