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Behavioural Intervention

Vagus Nerve Stimulation for Insulin Levels (TaVNS Trial)

N/A

Waitlist Available

Led By Thomas V Nowak, MD

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Willing to have electrodes placed in the external ear

Healthy Volunteers aged 18-70

Must not have

Unwilling to have the taVNS device placed in their ear

Diabetes diagnosis per patient report

Timeline

Screening 3 weeks

Treatment Varies

Follow Up two years

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to see if stimulating the vagus nerve, which connects the brain to the gut, can impact insulin, C-peptide, and glucose levels. C-peptide is produced when insulin is

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort at the stimulation site or mild headaches. Since it's non-invasive, serious side effects are unlikely but will be monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am willing to have electrodes placed on my ear.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not want the taVNS device in my ear.

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I have been diagnosed with diabetes.

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I am unable to give my consent.

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I have been diagnosed with gastric motility issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ two years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~two years

This trial's timeline: 3 weeks for screening, Varies for treatment, and two years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Expectation

Expectation #2

Expectation #3

Secondary study objectives

Secondary/Exploratory Expectations

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transcutaneous Auricular Vagus Nerve Stimulation

2023

N/A

~130

0 / 6Eligibility criteria met