Vagus Nerve Stimulation for Insulin Levels

(TaVNS Trial)

Overseen By

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Must not be taking: Alpha blockers, Beta blockers

Disqualifiers: Diabetes, Gastric motility issues, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether stimulating the vagus nerve with a device behind the ear can affect insulin, C-peptide, and glucose levels. The vagus nerve connects the brain to the large intestine and influences many functions, including stomach operation. Researchers hope this could lead to new treatments for nausea, vomiting, disordered stomach function, or diabetes. Participants should be healthy volunteers willing to wear electrodes on their neck, chest, and ear, and have blood drawn during the study. As an unphased trial, this study offers the chance to contribute to groundbreaking research that could pave the way for innovative treatments.

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 prior data suggests that this method is safe for influencing insulin levels?

Research has shown that transcutaneous auricular vagus nerve stimulation (taVNS) is generally well-tolerated. In past studies, taVNS helped control blood sugar levels without major safety issues or serious side effects, suggesting short-term safety for people.

This type of nerve stimulation involves a small device placed behind the ear, which sends gentle electrical signals to the vagus nerve. This nerve helps regulate important body functions, such as digestion and heart rate.

While the safety of taVNS appears promising, participants should discuss any concerns with their doctor. Understanding potential risks and benefits is crucial before joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about transcutaneous auricular vagus nerve stimulation (taVNS) for managing insulin levels because it offers a novel, non-invasive approach. Unlike standard treatments for insulin regulation, which often involve medications or lifestyle changes, taVNS uses electrical stimulation on the ear to potentially influence insulin levels. This method stands out because it targets the vagus nerve, which plays a role in various bodily functions, including metabolism, without the need for pharmaceuticals. Additionally, the ease of using a TENS device makes this approach accessible and potentially less intimidating for patients.

What evidence suggests that Transcutaneous Auricular Vagus Nerve Stimulation might be an effective treatment for insulin levels?

Research has shown that transcutaneous auricular vagus nerve stimulation (taVNS), which participants in this trial will receive, might help control insulin and sugar levels in the body. Studies have found that taVNS can lower blood sugar and improve the body's sugar management. It also affects hormones related to insulin production. This treatment stimulates the vagus nerve, crucial for digestion and other body functions. Overall, early research suggests taVNS could be a promising method for managing blood sugar levels, potentially benefiting people with conditions like diabetes. ^{1 2 3 5 6}

Who Is on the Research Team?

Thomas V Nowak, MD

Principal Investigator

IU Medical Scool

Are You a Good Fit for This Trial?

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

I am willing to have electrodes placed on my ear.

I am a healthy volunteer between 18 and 70 years old.

I am willing to have ECG electrodes placed on my neck and chest.

Exclusion Criteria

I do not want the taVNS device in my ear.

I have been diagnosed with diabetes.

Unwilling to consent to a blood draw

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Measurement

Participants undergo baseline measurements including ECG and blood sample collection before stimulation

20 minutes

1 visit (in-person)

Stimulation

Participants receive transcutaneous auricular vagus nerve stimulation for 40 minutes, followed by blood sample collection

40 minutes

1 visit (in-person)

Post-Stimulation Observation

Participants are observed for 20 minutes post-stimulation, and a final blood sample is collected

20 minutes

1 visit (in-person)

Follow-up

Participants are monitored for changes in plasma insulin, C-peptide, glucose levels, and heart rate variability over one month

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)

Trial Overview The study tests if Transcutaneous Auricular Vagus Nerve Stimulation (taVNS), which is non-invasive stimulation behind the ear, can influence insulin, C-peptide, and glucose levels in the body.

How Is the Trial Designed?

Group I: Stimulation Experimental Treatment 1 Intervention

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.

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) is already approved in United States, European Union, China for the following indications:

Approved in United States as Transcutaneous Auricular Vagus Nerve Stimulation for:

• Post-stroke pain management
• Upper limb rehabilitation post-stroke

Approved in European Union as Transcutaneous Auricular Vagus Nerve Stimulation for:

• Epilepsy
• Depression
• Tinnitus
• Post-stroke upper limb function improvement

Approved in China as Transcutaneous Auricular Vagus Nerve Stimulation for:

• Stroke rehabilitation
• Upper limb functional restoration post-stroke

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Published Research Related to This Trial

Transcutaneous auricular vagus nerve stimulation (TaVNS) effectively normalized gastric dysrhythmias in healthy individuals during a water-load test, indicating its potential as a treatment for gastric symptoms.

The study found that TaVNS at 40 Hz improved heart rate variability and reduced bloating, suggesting it positively influences both parasympathetic and sympathetic nervous system pathways.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Auricular Vagus Nerve Stimulation Normalizes Induced Gastric Myoelectrical Dysrhythmias in Controls Assessed by Body-Surface Gastric Mapping. Du, P., Maharjan, A., Calder, S., et al.[2023]

Transcutaneous auricular vagus nerve stimulation (taVNS) significantly improves depression symptoms, as evidenced by reduced scores on the Hamilton Depression Scale in a review of 12 studies involving 838 participants.

taVNS shows comparable response rates to traditional antidepressants and has fewer side effects, suggesting it could be a safe alternative or complementary treatment for depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy and safety of transcutaneous auricular vagus nerve stimulation in the treatment of depressive disorder: A systematic review and meta-analysis of randomized controlled trials. Tan, C., Qiao, M., Ma, Y., et al.[2023]

This study will investigate the effects of transcutaneous auricular vagus nerve stimulation (taVNS) on 15 patients with a minimally conscious state, using five different frequencies (1, 10, 25, 50, and 100 Hz) to determine the optimal stimulation parameters.

The goal is to achieve stable improvements in consciousness levels in patients with disorders of consciousness by optimizing the taVNS neuromodulation technique, with results measured through the coma recovery scale-revised (CRS-R) and resting EEG assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing the modulation paradigm of transcutaneous auricular vagus nerve stimulation in patients with disorders of consciousness: A prospective exploratory pilot study protocol. Zhai, W., Jiao, H., Zhuang, Y., et al.[2023]

Transcutaneous auricular vagus nerve stimulation (taVNS) significantly improved upper limb motor function in 21 subacute ischemic stroke patients compared to a sham treatment, as measured by the Fugl-Meyer assessment and other functional tests after 15 days of intervention.

The study found taVNS to be safe, with only one reported case of skin redness, indicating it may be a beneficial and low-risk option for enhancing recovery in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect and Safety of Transcutaneous Auricular Vagus Nerve Stimulation on Recovery of Upper Limb Motor Function in Subacute Ischemic Stroke Patients: A Randomized Pilot Study. Wu, D., Ma, J., Zhang, L., et al.[2021]

Transcutaneous auricular vagus nerve stimulation (taVNS) is generally safe, with a low incidence of mild and transient adverse effects, such as ear pain, headache, and tingling, reported in only 24.86% of the studies analyzed.

In a systematic review of 177 studies involving 6322 subjects, there was no significant difference in the risk of adverse events between taVNS and control groups, indicating that taVNS is a feasible option for clinical intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of transcutaneous auricular vagus nerve stimulation (taVNS): a systematic review and meta-analysis. Kim, AY., Marduy, A., de Melo, PS., et al.[2023]

Transcutaneous auricular vagus nerve stimulation (taVNS) is a safe and effective neuromodulation therapy for a variety of conditions, including epilepsy, depression, and anxiety, indicating its broad therapeutic potential.

Despite its effectiveness, there is currently no standardization among taVNS devices, and further research is needed to clarify the relationship between stimulation parameters and therapeutic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous auricular vagus nerve stimulators: a review of past, present, and future devices. Wang, L., Wang, Y., Wang, Y., et al.[2022]

Transcutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive and cost-effective method for modulating the vagus nerve, making it a promising alternative to traditional surgical vagus nerve stimulation.

taVNS allows for easy and safe administration, with considerations for proper electrode placement and individual dosing based on perception thresholds, which enhances its potential for treating various central and peripheral diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laboratory Administration of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS): Technique, Targeting, and Considerations. Badran, BW., Yu, AB., Adair, D., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4227038/

Effect of transcutaneous auricular vagus nerve stimulation on ... Results showed that compared with sham taVNS, taVNS significantly reduced the two-hour glucose tolerance. In addition, we found that taVNS significantly ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06597149

Effect of Transcutaneous Auricular Vagus Nerve ... To determine if acute taVNS stimulation of the cymba concha area of the external ear in human subjects affects plasma insulin, C-peptide, and glucose levels.

3. frontiersin.org frontiersin.org/journals/neuroscience/articles/10.3389/fnins.2024.1471387/full

Transcutaneous auricular vagal nerve stimulation ... The results of this study indicate that taVNS regulates intestinal melatonin and its receptor system, effectively lowering blood glucose levels ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04926415

NCT04926415 | Effects of Transcutaneous Auricular Vagus ... The investigators expect that the outcome of this study will demonstrate that taVNS lowers blood glucose levels and elicits hormone/adipokine responses ...

5. trialx.com trialx.com/clinical-trials/listings/317279/effect-of-transcutaneous-auricular-vagus-nerve-stimulation-tavns-on-plasma-insulin-levels/?&radius=10&place=Seoul,%20etc.&user_country=Korea,%20Republic%20of

Effect of Transcutaneous Auricular Vagus Nerve ... Investigators hope that by stimulating the vagal nerve using the TeNS behind the ear, this stimulation can affect insulin levels, and this will ...

6. nature.com nature.com/articles/s41598-025-01964-6

Transcutaneous auricular vagus nerve stimulation inhibits ... This study aims to investigate the effects of taVNS on food intake, body weight, and blood glucose levels in mice subjected to a high-fat diet ( ...