Healthy SubjectsABVN1NCT04206540
ABVN Phase 1 - Ear Stimulation
A study testing Transcutaneous Auricular Vagus Nerve Stimulation in people with Healthy Subjects, run by Indiana University at 1 site in United States.
Trial summary
The vagus nerve is a nerve that controls many bodily functions, including stomach function. Investigators hope that electrically stimulating the nerve around the external ear will also stimulate the internal vagus nerve. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Transcutaneous Auricular Vagus Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2019to 29 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers
- Aged 18-80 years
- Willing to have electrodes placed in the external ear
Who cannot join
- Unable to provide consent
- Having gastric motility issues (excluding those due to COVID19) as determined by the PI or Sub I
- Taking medications affecting gastric motility
- Pregnant females
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Hosptial
Indianapolis, Indiana, 46202
About this study
Official title: Effect of Electrical Stimulation of the Auricular Branch of the Vagus Nerve (ABVN) on Cervical Vagus Nerve Compound Nerve Action Potentials (CNAPs) Phase 1 - Ear Stimulation
The vagus nerve is a nerve that controls many bodily functions, including stomach function. Investigators hope that electrically stimulating the nerve around the external ear will also stimulate the internal vagus nerve. If it does, then investigators hope that this may lead to additional treatment options for patients with nausea and vomiting and disordered stomach function.
The overall purpose of the ABVN Phase 1 grant is to evaluate the effects of noninvasive stimulation on vagal nerve function. This will be accomplished through several independent, but related, studies. In this study, investigators will evaluate the effect of transcutaneous electrical stimulation of the auricular branch of the vagus nerve (ABVN) on compound nerve action potentials (CNAPs) in healthy subjects.
Read the detailed description
Only healthy volunteer subjects will be recruited and studied for this project, which is designed to determine whether transcutaneous stimulation of the auricular branch of the vagus nerve (ABVN) will also produce cervical vagus nerve compound action potentials.
Participation involves a single visit lasting up to 3 hours in duration.
When participants arrive, they will be fitted with:
- Two small disc electrodes will be placed in the auricle of the left ear, fixed by a plastic armature that wraps around the ear. The leads from the electrodes are connected to a stimulator. Electrical stimulation of the electrodes placed in the ear is provided by a current-constant stimulator. The stimuli consist of rectangular pulses with 450 µs pulse width, delivered at 30 Hz, and pulse train duration of 0.5 seconds. Stimulation is gated and delivered only during the expiratory phase of respiration.
- A pneumatic belt will be placed around the lower thorax. Pneumatic tubes connect this belt to a pressure transducer that measures changes in chest diameter during breathing and sends signal to a laptop-controlled device.
- Two ECG electrodes placed on both sides of the neck overlying the area near the carotid artery where the vagus nerve is superficial. This is to measure the vagal action potentials in the neck.
- Three ECG electrodes, one on each arm and one on the chest for measurement of the electrocardiogram (ECG).
- Three ECG electrodes on the abdomen in a line parallel to the longitudinal axis of the stomach to record the electrogastrogram (EGG).
Baseline vagal nerve, ECG and EGG will be recorded for at least 5 minutes. During the baseline recording, no current is delivered to the ear.
Test procedure:
At the completion of the baseline recording, electrical stimulation will be sent to the ear electrodes at an intensity which should not cause pain. The current will be increased and decreased by 10 percent for 60 seconds until a comfortable level of sensation has been reached. Once the comfortable level of sensation has been identified (target level), the target level stimulation will be delivered for a total of 2 minutes. Stimuli are then delivered at 50% and 25% of the target level for 2 minutes, respectively. Continuous vagal nerve, ECG, and EGG recordings are obtained during all stimulation periods.
- Conditions
- Healthy Subjects
- Being tested
- Transcutaneous Auricular Vagus Nerve Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Auricular Vagus Nerve StimulationDevice
Also called ML1101 Stimulus Isolator
Electrical stimulation of the vagus nerve around the external ear using a transcutaneous device. Electrical current will be increased in intensity based on subject feedback.
Electrical stimulation will be delivered for 2 minutes once the subject reports the maximum comfortable intensity.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Subjects | Experimental | Healthy volunteers aged 18-80 years old who will undergo vagus nerve stimulation. Receives: Device: Transcutaneous Auricular Vagus Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with vagal nerve activation
The number of healthy volunteers in which vagal nerve compound action potentials (CNAPs) can be detected during transcutaneous stimulation of the auricular branch of the vagal nerve.
Measured: 3 hours
Number of participants with an increase in surface electrogastogram amplitude
The amplitude of the surface electrogastrogram (EGG) in healthy volunteers during transcutaneous stimulation of the auricular branch of the vagal nerve will be measured to determine whether transcutaneous stimulation increases surface EGG amplitude. The average of 10 cycles of "on values" (during stimulation) is compared with 10 cycles of the "off values" (no stimulation) to determine whether an increase in EGG amplitude occurred with stimulation.
Measured: 3 hours
Percent Change in Heart Rate Variability
Changes in heart rate variability in healthy volunteers during transcutaneous stimulation of the auricular branch of the vagal nerve. This will be measured in SDNN (standard deviation of normal to normal intervals in the EKG). The participants' SDNN during stimulation is on is compared with the SDNN under no stimulation. The average of 10 cycles of "on values" (during stimulation) is compared with 10 cycles of the "off values" (no stimulation) as a percent change of SDNN.
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study start22 Jul 2019
- Primary completion29 Jan 2020
- Study completion29 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Purdue University, National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Thomas V. Nowak, Indiana University
- Investigators
- Thomas V Nowak, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04206540
- Sponsor's protocol ID
- 1809683671-A
- Other IDs
- 1OT2OD023847-01
- Acronym
- ABVN1
- Status last verified
- Aug 2026
- First submitted
- 18 Dec 2019
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Electrical Stimulation of the Auricular Branch of the Vagus Nerve (ABVN) on Cervical Vagus Nerve Compound Nerve Action Potentials (CNAPs) Phase 1 - Ear Stimulation
- ClinicalTrials.gov ID
- NCT04206540
- Acronym / sponsor ID
- ABVN1 / 1809683671-A
- Conditions
- Healthy Subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Purdue University, National Institutes of Health (NIH)
- Study start
- 22 Jul 2019 (actual)
- Primary completion
- 29 Jan 2020 (actual)
- Study completion
- 29 Jan 2020 (actual)
- First posted
- 20 Dec 2019 (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 nerve is a nerve that controls many bodily functions, including stomach function. Investigators hope that electrically stimulating the nerve around the external ear will also stimulate the internal vagus nerve. If it does, then investigators hope that this may lead to additional treatment options for patients with nausea and vomiting and disordered stomach function.
The overall purpose of the ABVN Phase 1 grant is to evaluate the effects of noninvasive stimulation on vagal nerve function. This will be accomplished through several independent, but related, studies. In this study, investigators will evaluate the effect of transcutaneous electrical stimulation of the auricular branch of the vagus nerve (ABVN) on compound nerve action potentials (CNAPs) in healthy subjects.
Detailed description
Only healthy volunteer subjects will be recruited and studied for this project, which is designed to determine whether transcutaneous stimulation of the auricular branch of the vagus nerve (ABVN) will also produce cervical vagus nerve compound action potentials.
Participation involves a single visit lasting up to 3 hours in duration.
When participants arrive, they will be fitted with:
- Two small disc electrodes will be placed in the auricle of the left ear, fixed by a plastic armature that wraps around the ear. The leads from the electrodes are connected to a stimulator. Electrical stimulation of the electrodes placed in the ear is provided by a current-constant stimulator. The stimuli consist of rectangular pulses with 450 µs pulse width, delivered at 30 Hz, and pulse train duration of 0.5 seconds. Stimulation is gated and delivered only during the expiratory phase of respiration.
- A pneumatic belt will be placed around the lower thorax. Pneumatic tubes connect this belt to a pressure transducer that measures changes in chest diameter during breathing and sends signal to a laptop-controlled device.
- Two ECG electrodes placed on both sides of the neck overlying the area near the carotid artery where the vagus nerve is superficial. This is to measure the vagal action potentials in the neck.
- Three ECG electrodes, one on each arm and one on the chest for measurement of the electrocardiogram (ECG).
- Three ECG electrodes on the abdomen in a line parallel to the longitudinal axis of the stomach to record the electrogastrogram (EGG).
Baseline vagal nerve, ECG and EGG will be recorded for at least 5 minutes. During the baseline recording, no current is delivered to the ear.
Test procedure:
At the completion of the baseline recording, electrical stimulation will be sent to the ear electrodes at an intensity which should not cause pain. The current will be increased and decreased by 10 percent for 60 seconds until a comfortable level of sensation has been reached. Once the comfortable level of sensation has been identified (target level), the target level stimulation will be delivered for a total of 2 minutes. Stimuli are then delivered at 50% and 25% of the target level for 2 minutes, respectively. Continuous vagal nerve, ECG, and EGG recordings are obtained during all stimulation periods.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Subjects | Experimental | Device: Transcutaneous Auricular Vagus Nerve StimulationHealthy volunteers aged 18-80 years old who will undergo vagus nerve stimulation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy volunteers
- Aged 18-80 years
- Willing to have electrodes placed in the external ear
Key exclusion criteria (5 listed)
- Unable to provide consent
- Having gastric motility issues (excluding those due to COVID19) as determined by the PI or Sub I
- Taking medications affecting gastric motility
- Pregnant females
- Prisoners
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 StimulationAlso: ML1101 Stimulus IsolatorElectrical stimulation of the vagus nerve around the external ear using a transcutaneous device. Electrical current will be increased in intensity based on subject feedback. Electrical stimulation will be delivered for 2 minutes once the subject reports the maximum comfortable intensity. | Device | Healthy Subjects |
Primary outcome
Number of participants with vagal nerve activation
Time frame: 3 hours
The number of healthy volunteers in which vagal nerve compound action potentials (CNAPs) can be detected during transcutaneous stimulation of the auricular branch of the vagal nerve.
Number of participants with an increase in surface electrogastogram amplitude
Time frame: 3 hours
The amplitude of the surface electrogastrogram (EGG) in healthy volunteers during transcutaneous stimulation of the auricular branch of the vagal nerve will be measured to determine whether transcutaneous stimulation increases surface EGG amplitude. The average of 10 cycles of "on values" (during stimulation) is compared with 10 cycles of the "off values" (no stimulation) to determine whether an increase in EGG amplitude occurred with stimulation.
Percent Change in Heart Rate Variability
Time frame: 3 hours
Changes in heart rate variability in healthy volunteers during transcutaneous stimulation of the auricular branch of the vagal nerve. This will be measured in SDNN (standard deviation of normal to normal intervals in the EKG). The participants' SDNN during stimulation is on is compared with the SDNN under no stimulation. The average of 10 cycles of "on values" (during stimulation) is compared with 10 cycles of the "off values" (no stimulation) as a percent change of SDNN.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Thomas V Nowak, MD principal investigator
Indiana University
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 Subjects, 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 16 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with vagal nerve activation (time frame: 3 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Oct 2026.