30 Participants Needed

Vagus Nerve Stimulation for Insulin Levels

(TaVNS Trial)

MS
Overseen By
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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?

Transcutaneous auricular vagus nerve stimulation (taVNS) is generally considered safe for humans, with only mild and temporary side effects like ear pain, headache, and tingling. A large review found no increased risk of serious adverse events compared to controls.14678

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

TV

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

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.
See 1 more

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
See 6 more

Timeline

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

Treatment Details

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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: StimulationExperimental Treatment1 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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials
1,063
Recruited
1,182,000+

Findings from Research

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.
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]
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.
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.
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]

References

Transcutaneous Auricular Vagus Nerve Stimulation Normalizes Induced Gastric Myoelectrical Dysrhythmias in Controls Assessed by Body-Surface Gastric Mapping. [2023]
Transcutaneous auricular vagus nerve stimulation augments postprandial inhibition of ghrelin. [2022]
[Effect of transcutaneous auricular vagus nerve stimulation on hyperglycemia and insulin receptors expression in impaired glucose tolerance rats]. [2020]
Optimizing the modulation paradigm of transcutaneous auricular vagus nerve stimulation in patients with disorders of consciousness: A prospective exploratory pilot study protocol. [2023]
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. [2021]
Safety of transcutaneous auricular vagus nerve stimulation (taVNS): a systematic review and meta-analysis. [2023]
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. [2023]
Transcutaneous auricular vagus nerve stimulators: a review of past, present, and future devices. [2022]
Constant hepatic ATP concentrations during prolonged fasting and absence of effects of Cerbomed Nemos® on parasympathetic tone and hepatic energy metabolism. [2019]
10.United Statespubmed.ncbi.nlm.nih.gov
Laboratory Administration of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS): Technique, Targeting, and Considerations. [2020]
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