HealthyTaVNSNCT06597149
Effect of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) on Plasma Insulin Levels
A study testing Transcutaneous Auricular Vagus Nerve Stimulation in people with Healthy, run by Indiana University at 1 site in United States.
Trial summary
The vagus or vagal nerve is a nerve that sends signals from the brain to other parts of the body to control involuntary functionm, including stomach function, and it is important to the regulation of insulin, C-peptide, and glucose levels. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Transcutaneous Auricular Vagus Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2025to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Volunteers
- Aged 18-70
- Willing to have ECG electrodes placed on their neck and chest areas.
- Willing to have electrodes placed in the external ear.
- Willing to have an indwelling catheter placed to avoid multiple sticks for blood draw.
Who cannot join
- Unable to provide consent.
- Diabetes diagnosis per patient report
- Having known allergies to adhesive on electrode pads or bandages
- Having gastric motility issues as determined by the PI or clinical coordinator.
- Taking any medications that may affect gastric motility or cardiac variability, i.e. alpha or beta blockers for hypertension.
- Pregnant females
Show all 9Show fewer
- Those unwilling to have the taVNS device placed in their ear.
- Those unwilling to consent to a blood draw.
- Prisoners
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Indiana University Hospital
Indianapolis, Indiana, 46202
Maureen Schilling, BS, 3172782064, maschi@iu.edu
Thomas V Nowak, MD, 3179484272, tvnowak@iu.edu
About this study
The vagus or vagal nerve is a nerve that sends signals from the brain to other parts of the body to control involuntary functionm, including stomach function, and it is important to the regulation of insulin, C-peptide, and glucose levels. The purpose of this study is to evaluate whether electrically stimulating the nerve around the external ear will also stimulate the internal vagus nerve and influence the levels of insulin, C-peptide, and glucose. If it does, investigators hope that this will help innovate treatment of patients with nausea, vomiting, and disordered stomach function, and patients with diabetes.
Read the detailed description
Healthy volunteer subjects will be recruited for this project, which will be completed at a up to 2 study visits.
Prior to each visit, participants will be asked not to eat or drink anything (except a small amount of water to take medications) for 8-10 hours.
When participants arrive to Study Visit 1, they will be asked to lie in a supine position and will be fitted with:
- ECG electrodes, placed on the chest, arms/legs for electrocardiogram (ECG) recordings and behind each ear and just below the jaw on each side to record vagal nerve activity
- a butterfly needle catether for blood sample collections.
After the ECG electrodes are placed and the butterfly needle catheter is inserted, the first of 4 blood samples will be collected. The TENS unit clip will then be placed (after cleaning the left ear with an alcohol wipe) and a 20 minute baseline recording will be made, followed by the collection of a second blood sample.
Participants will then undergo their randomly assigned experimental condition (either active stimulation delivered via the TENS device, or no stimulation) for 40 minutes. At the end of the experimental period, a third blood sample is collected and the TENS device is turned off (for participants in the active stimulation group). Participants will then continue to lie on their back for an additional 20 minutes of recovery, after which the fourth and final blood sample is collected. The TENS clip is then removed and the study visit is complete.
Continuous vagal nerve and ECG recordings are obtained during the baseline, experimental, and recovery periods.
Participants will be asked if they wish to return for a second study visit, at which no TENS clip will be placed but the remaining Visit 1 procedures will be repeated.
- Conditions
- Healthy
- Being tested
- Transcutaneous Auricular Vagus Nerve Stimulation, Sham Procedure (No Stimulation)
- Keywords
- Healthy, Individual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Auricular Vagus Nerve StimulationDevice
For participants in the active stimulation group, electrical stimuli are delivered continuously for 40 minutes at a pulse width of 300 microseconds, pulse frequency of 25 Hz, and pulse amplitude of 0.5 to 1.5 mA based on the tolerance of the patient. Stimuli current and frequency may be decreased, if necessary, to minimize participant discomfort.
Sham Procedure (No Stimulation)Device
The TENS device will be placed but not turned on.
| Study group | Role | What they receive |
|---|---|---|
| Active Stimulation, then No electrodes | Experimental | After an initial baseline blood sample is drawn, a TENS unit electrode clip will be placed on the inside of the outer ear and vagal nerve recordings are initiated. After 20 minutes of baseline recording, a second blood sample is drawn, after which, the TENS unit is turned ON for 40 minutes of stimulation. At the end of the stimulation period, a third blood sample is drawn and the TENS device is then turned OFF. After 20 minutes of recovery, a fourth and final sample of blood is drawn. Vagal nerve activity recordings are continued until the final blood sample is drawn.
Subjects will be asked to return for an additional visit during which the TENS unit will not be placed, but the same vagal nerve recordings and blood draws will be obtained. Receives: Device: Transcutaneous Auricular Vagus Nerve Stimulation |
| Sham Stimulation, then No Electrodes | Sham comparator | After an initial baseline blood sample is drawn, a TENS unit electrode clip will be placed on the inside of the outer ear, but will not be turned on. Vagal nerve recordings will be initiated. After 20, 60 and 80 minutes, additional blood samples are drawn. Vagal nerve activity recordings are continued until the final blood sample is drawn.
Subjects will be asked to return for an additional visit during which the TENS unit will not be placed, but the same vagal nerve recordings and blood draws will be obtained. Receives: Device: Sham Procedure (No Stimulation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma insulin levels
Repeated measures analysis of variance will be used to determine the effects of stimulation period (baseline, end of stimulation, end of non-stimulation) and active/control group on plasma insulin levels.
Measured: Study Days 1 and 2
Change in C-peptide levels
Repeated measures analysis of variance will be used to determine the effects of stimulation period (baseline, end of stimulation, end of non-stimulation) and active/control group on C-peptide levels.
Measured: Study Days 1 and 2
Change in glucose levels
Repeated measures analysis of variance will be used to determine the effects of stimulation period (baseline, end of stimulation, end of non-stimulation) and active/control group on glucose levels
Measured: Study Days 1 and 2
Change in heart rate variability
Repeated measures analysis of variance will be used to determine the effects of stimulation period (baseline, end of stimulation, end of non-stimulation) and active/control group on heart rate variability.
Measured: Study Days 1 and 2
Association between changes in heart rate variability and plasma insulin levels
Pearson's correlation coefficients will be used to evaluate the association between change in heart rate variability (end of stimulation minus baseline) with changes in plasma insulin levels (end of stimulation minus baseline). Heart rate variability will be used as an indication of changes in parasympathetic or sympathetic activation.
Measured: Study Days 1 and 2
Association between changes in heart rate variability and C-peptide levels
Pearson's correlation coefficients will be used to evaluate the association between change in heart rate variability (end of stimulation minus baseline) with changes in C-peptide levels (end of stimulation minus baseline). Heart rate variability will be used as an indication of changes in parasympathetic or sympathetic activation.
Measured: Study Days 1 and 2
Association between changes in heart rate variability and glucose levels
Pearson's correlation coefficients will be used to evaluate the association between change in heart rate variability (end of stimulation minus baseline) with changes in glucose levels (end of stimulation minus baseline). Heart rate variability will be used as an indication of changes in parasympathetic or sympathetic activation.
Measured: Study Days 1 and 2
Secondary outcomes (3)
Correlation between gender and changes in circulating plasma insulin levels
Pearson's correlation coefficient will be calculated for the association between change in circulating plasma insulin levels (end of stimulation minus baseline) and patient gender.
Measured: Study Days 1 and 2
Correlation between age and changes in circulating plasma insulin levels
Pearson's correlation coefficient will be calculated for the association between change in circulating plasma insulin levels (end of stimulation minus baseline) and patient age.
Measured: Study Days 1 and 2
Correlation between body mass index and changes in circulating plasma insulin levels
Pearson's correlation coefficient will be calculated for the association between change in circulating plasma insulin levels (end of stimulation minus baseline) and patient body mass index.
Measured: Study Days 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start21 Apr 2025
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas V. Nowak, Indiana University
- Investigators
- Thomas V Nowak, MD, Principal investigator, IU Medical Scool
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06597149
- Sponsor's protocol ID
- 24300
- Acronym
- TaVNS
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2024
- Last updated
- 1 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The blood samples collected will be processed in the CRC lab to obtain blood serum. This serum will then be transferred to Dr. Robert Considine at the Indiana University Center for Diabetes and Metabolic Diseases. These samples will only be identified with the study subject number and which blood draw number (1,2,3) the vial contains. ECG recordings are digitized and downloaded to a computer and are analyzed using heart rate variability software (LABVIEW, AD Instruments, Boston, MA). This software contains no references to any person and only contains the subject number for the study.
Publications
van der Voort IR, Becker JC, Dietl KH, Konturek JW, Domschke W, Pohle T. Gastric electrical stimulation results in improved metabolic control in diabetic patients suffering from gastroparesis. Exp Clin Endocrinol Diabetes. 2005 Jan;113(1):38-42. doi: 10.1055/s-2004-830525.
PubMed 15662594Huang F, Dong J, Kong J, Wang H, Meng H, Spaeth RB, Camhi S, Liao X, Li X, Zhai X, Li S, Zhu B, Rong P. Effect of transcutaneous auricular vagus nerve stimulation on impaired glucose tolerance: a pilot randomized study. BMC Complement Altern Med. 2014 Jun 26;14:203. doi: 10.1186/1472-6882-14-203.
PubMed 24968966Vosseler A, Zhao D, Fritsche L, Lehmann R, Kantartzis K, Small DM, Peter A, Haring HU, Birkenfeld AL, Fritsche A, Wagner R, Preissl H, Kullmann S, Heni M. No modulation of postprandial metabolism by transcutaneous auricular vagus nerve stimulation: a cross-over study in 15 healthy men. Sci Rep. 2020 Nov 24;10(1):20466. doi: 10.1038/s41598-020-77430-2.
PubMed 33235256Kozorosky EM, Lee CH, Lee JG, Nunez Martinez V, Padayachee LE, Stauss HM. Transcutaneous auricular vagus nerve stimulation augments postprandial inhibition of ghrelin. Physiol Rep. 2022 Apr;10(8):e15253. doi: 10.14814/phy2.15253.
PubMed 35441808Yin J, Ji F, Gharibani P, Chen JD. Vagal Nerve Stimulation for Glycemic Control in a Rodent Model of Type 2 Diabetes. Obes Surg. 2019 Sep;29(9):2869-2877. doi: 10.1007/s11695-019-03901-9.
PubMed 31222497Payne SC, Ward G, Fallon JB, Hyakumura T, Prins JB, Andrikopoulos S, MacIsaac RJ, Villalobos J. Blood glucose modulation and safety of efferent vagus nerve stimulation in a type 2 diabetic rat model. Physiol Rep. 2022 Apr;10(8):e15257. doi: 10.14814/phy2.15257.
PubMed 35439355Hampton RF, Jimenez-Gonzalez M, Stanley SA. Unravelling innervation of pancreatic islets. Diabetologia. 2022 Jul;65(7):1069-1084. doi: 10.1007/s00125-022-05691-9. Epub 2022 Mar 29.
PubMed 35348820Zhu Y, Xu F, Lu D, Rong P, Cheng J, Li M, Gong Y, Sun C, Wei W, Lin L, Chen JDZ. Transcutaneous auricular vagal nerve stimulation improves functional dyspepsia by enhancing vagal efferent activity. Am J Physiol Gastrointest Liver Physiol. 2021 May 1;320(5):G700-G711. doi: 10.1152/ajpgi.00426.2020. Epub 2021 Feb 24.
PubMed 33624527Krasaelap A, Sood MR, Li BUK, Unteutsch R, Yan K, Nugent M, Simpson P, Kovacic K. Efficacy of Auricular Neurostimulation in Adolescents With Irritable Bowel Syndrome in a Randomized, Double-Blind Trial. Clin Gastroenterol Hepatol. 2020 Aug;18(9):1987-1994.e2. doi: 10.1016/j.cgh.2019.10.012. Epub 2019 Oct 14.
PubMed 31622740
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) on Plasma Insulin Levels
- ClinicalTrials.gov ID
- NCT06597149
- Acronym / sponsor ID
- TaVNS / 24300
- Conditions
- Healthy
- Keywords
- Healthy, Individual
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 21 Apr 2025 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The vagus or vagal nerve is a nerve that sends signals from the brain to other parts of the body to control involuntary functionm, including stomach function, and it is important to the regulation of insulin, C-peptide, and glucose levels. The purpose of this study is to evaluate whether electrically stimulating the nerve around the external ear will also stimulate the internal vagus nerve and influence the levels of insulin, C-peptide, and glucose. If it does, investigators hope that this will help innovate treatment of patients with nausea, vomiting, and disordered stomach function, and patients with diabetes.
Detailed description
Healthy volunteer subjects will be recruited for this project, which will be completed at a up to 2 study visits.
Prior to each visit, participants will be asked not to eat or drink anything (except a small amount of water to take medications) for 8-10 hours.
When participants arrive to Study Visit 1, they will be asked to lie in a supine position and will be fitted with:
- ECG electrodes, placed on the chest, arms/legs for electrocardiogram (ECG) recordings and behind each ear and just below the jaw on each side to record vagal nerve activity
- a butterfly needle catether for blood sample collections.
After the ECG electrodes are placed and the butterfly needle catheter is inserted, the first of 4 blood samples will be collected. The TENS unit clip will then be placed (after cleaning the left ear with an alcohol wipe) and a 20 minute baseline recording will be made, followed by the collection of a second blood sample.
Participants will then undergo their randomly assigned experimental condition (either active stimulation delivered via the TENS device, or no stimulation) for 40 minutes. At the end of the experimental period, a third blood sample is collected and the TENS device is turned off (for participants in the active stimulation group). Participants will then continue to lie on their back for an additional 20 minutes of recovery, after which the fourth and final blood sample is collected. The TENS clip is then removed and the study visit is complete.
Continuous vagal nerve and ECG recordings are obtained during the baseline, experimental, and recovery periods.
Participants will be asked if they wish to return for a second study visit, at which no TENS clip will be placed but the remaining Visit 1 procedures will be repeated.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Stimulation, then No electrodes | Experimental | Device: Transcutaneous Auricular Vagus Nerve StimulationAfter an initial baseline blood sample is drawn, a TENS unit electrode clip will be placed on the inside of the outer ear and vagal nerve recordings are initiated. After 20 minutes of baseline recording, a second blood sample is drawn, after which, the TENS unit is turned ON for 40 minutes of stimulation. At the end of the stimulation period, a third blood sample is drawn and the TENS device is then turned OFF. After 20 minutes of recovery, a fourth and final sample of blood is drawn. Vagal nerve activity recordings are continued until the final blood sample is drawn. Subjects will be asked to return for an additional visit during which the TENS unit will not be placed, but the same vagal nerve recordings and blood draws will be obtained. |
| Sham Stimulation, then No Electrodes | Sham comparator | Device: Sham Procedure (No Stimulation)After an initial baseline blood sample is drawn, a TENS unit electrode clip will be placed on the inside of the outer ear, but will not be turned on. Vagal nerve recordings will be initiated. After 20, 60 and 80 minutes, additional blood samples are drawn. Vagal nerve activity recordings are continued until the final blood sample is drawn. Subjects will be asked to return for an additional visit during which the TENS unit will not be placed, but the same vagal nerve recordings and blood draws will be obtained. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy Volunteers
- Aged 18-70
- Willing to have ECG electrodes placed on their neck and chest areas.
- Willing to have electrodes placed in the external ear.
- Willing to have an indwelling catheter placed to avoid multiple sticks for blood draw.
Key exclusion criteria (9 listed)
- Unable to provide consent.
- Diabetes diagnosis per patient report
- Having known allergies to adhesive on electrode pads or bandages
- Having gastric motility issues as determined by the PI or clinical coordinator.
- Taking any medications that may affect gastric motility or cardiac variability, i.e. alpha or beta blockers for hypertension.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Auricular Vagus Nerve StimulationFor participants in the active stimulation group, electrical stimuli are delivered continuously for 40 minutes at a pulse width of 300 microseconds, pulse frequency of 25 Hz, and pulse amplitude of 0.5 to 1.5 mA based on the tolerance of the patient. Stimuli current and frequency may be decreased, if necessary, to minimize participant discomfort. | Device | Active Stimulation, then No electrodes |
| Sham Procedure (No Stimulation)The TENS device will be placed but not turned on. | Device | Sham Stimulation, then No Electrodes |
Primary outcome
Change in plasma insulin levels
Time frame: Study Days 1 and 2
Repeated measures analysis of variance will be used to determine the effects of stimulation period (baseline, end of stimulation, end of non-stimulation) and active/control group on plasma insulin levels.
Change in C-peptide levels
Time frame: Study Days 1 and 2
Repeated measures analysis of variance will be used to determine the effects of stimulation period (baseline, end of stimulation, end of non-stimulation) and active/control group on C-peptide levels.
Change in glucose levels
Time frame: Study Days 1 and 2
Repeated measures analysis of variance will be used to determine the effects of stimulation period (baseline, end of stimulation, end of non-stimulation) and active/control group on glucose levels
Change in heart rate variability
Time frame: Study Days 1 and 2
Repeated measures analysis of variance will be used to determine the effects of stimulation period (baseline, end of stimulation, end of non-stimulation) and active/control group on heart rate variability.
Association between changes in heart rate variability and plasma insulin levels
Time frame: Study Days 1 and 2
Pearson's correlation coefficients will be used to evaluate the association between change in heart rate variability (end of stimulation minus baseline) with changes in plasma insulin levels (end of stimulation minus baseline). Heart rate variability will be used as an indication of changes in parasympathetic or sympathetic activation.
Association between changes in heart rate variability and C-peptide levels
Time frame: Study Days 1 and 2
Pearson's correlation coefficients will be used to evaluate the association between change in heart rate variability (end of stimulation minus baseline) with changes in C-peptide levels (end of stimulation minus baseline). Heart rate variability will be used as an indication of changes in parasympathetic or sympathetic activation.
Association between changes in heart rate variability and glucose levels
Time frame: Study Days 1 and 2
Pearson's correlation coefficients will be used to evaluate the association between change in heart rate variability (end of stimulation minus baseline) with changes in glucose levels (end of stimulation minus baseline). Heart rate variability will be used as an indication of changes in parasympathetic or sympathetic activation.
3 secondary outcomes
Correlation between gender and changes in circulating plasma insulin levels
Time frame: Study Days 1 and 2
Correlation between age and changes in circulating plasma insulin levels
Time frame: Study Days 1 and 2
Correlation between body mass index and changes in circulating plasma insulin levels
Time frame: Study Days 1 and 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Background: PubMed 15662594van der Voort IR, Becker JC, Dietl KH, Konturek JW, Domschke W, Pohle T. Gastric electrical stimulation results in improved metabolic control in diabetic patients suffering from gastroparesis. Exp Clin Endocrinol Diabetes. 2005 Jan;113(1):38-42. doi: 10.1055/s-2004-830525.
- Background: PubMed 24968966Huang F, Dong J, Kong J, Wang H, Meng H, Spaeth RB, Camhi S, Liao X, Li X, Zhai X, Li S, Zhu B, Rong P. Effect of transcutaneous auricular vagus nerve stimulation on impaired glucose tolerance: a pilot randomized study. BMC Complement Altern Med. 2014 Jun 26;14:203. doi: 10.1186/1472-6882-14-203.
- Background: PubMed 33235256Vosseler A, Zhao D, Fritsche L, Lehmann R, Kantartzis K, Small DM, Peter A, Haring HU, Birkenfeld AL, Fritsche A, Wagner R, Preissl H, Kullmann S, Heni M. No modulation of postprandial metabolism by transcutaneous auricular vagus nerve stimulation: a cross-over study in 15 healthy men. Sci Rep. 2020 Nov 24;10(1):20466. doi: 10.1038/s41598-020-77430-2.
- Background: PubMed 35441808Kozorosky EM, Lee CH, Lee JG, Nunez Martinez V, Padayachee LE, Stauss HM. Transcutaneous auricular vagus nerve stimulation augments postprandial inhibition of ghrelin. Physiol Rep. 2022 Apr;10(8):e15253. doi: 10.14814/phy2.15253.
- Background: PubMed 31222497Yin J, Ji F, Gharibani P, Chen JD. Vagal Nerve Stimulation for Glycemic Control in a Rodent Model of Type 2 Diabetes. Obes Surg. 2019 Sep;29(9):2869-2877. doi: 10.1007/s11695-019-03901-9.
- Background: PubMed 35439355Payne SC, Ward G, Fallon JB, Hyakumura T, Prins JB, Andrikopoulos S, MacIsaac RJ, Villalobos J. Blood glucose modulation and safety of efferent vagus nerve stimulation in a type 2 diabetic rat model. Physiol Rep. 2022 Apr;10(8):e15257. doi: 10.14814/phy2.15257.
- Background: PubMed 35348820Hampton RF, Jimenez-Gonzalez M, Stanley SA. Unravelling innervation of pancreatic islets. Diabetologia. 2022 Jul;65(7):1069-1084. doi: 10.1007/s00125-022-05691-9. Epub 2022 Mar 29.
- Background: PubMed 33624527Zhu Y, Xu F, Lu D, Rong P, Cheng J, Li M, Gong Y, Sun C, Wei W, Lin L, Chen JDZ. Transcutaneous auricular vagal nerve stimulation improves functional dyspepsia by enhancing vagal efferent activity. Am J Physiol Gastrointest Liver Physiol. 2021 May 1;320(5):G700-G711. doi: 10.1152/ajpgi.00426.2020. Epub 2021 Feb 24.
- Background: PubMed 31622740Krasaelap A, Sood MR, Li BUK, Unteutsch R, Yan K, Nugent M, Simpson P, Kovacic K. Efficacy of Auricular Neurostimulation in Adolescents With Irritable Bowel Syndrome in a Randomized, Double-Blind Trial. Clin Gastroenterol Hepatol. 2020 Aug;18(9):1987-1994.e2. doi: 10.1016/j.cgh.2019.10.012. Epub 2019 Oct 14.
- Individual participant dataSharing planned: No. The blood samples collected will be processed in the CRC lab to obtain blood serum. This serum will then be transferred to Dr. Robert Considine at the Indiana University Center for Diabetes and Metabolic Diseases. These samples will only be identified with the study subject number and which blood draw number (1,2,3) the vial contains. ECG recordings are digitized and downloaded to a computer and are analyzed using heart rate variability software (LABVIEW, AD Instruments, Boston, MA). This software contains no references to any person and only contains the subject number for the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas V Nowak, MD principal investigator
IU Medical Scool
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Auricular Vagus Nerve Stimulation in people with Healthy, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maureen Schilling, BS (3172782064, maschi@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in plasma insulin levels (time frame: Study Days 1 and 2). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06597149, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.