Healthy SubjectsABVN2NCT07856446
ABVN Phase 2 - PENFS
A study testing Percutaneous Electrical Nerve Field Stimulation (PENFS) 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?
- Percutaneous Electrical Nerve Field Stimulation (PENFS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2021to 9 Jun 2022
- 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
- No gastrointestinal symptoms or conditions
- Aged 18-80 years
- Willing to have electrodes placed in the external ear
- Willing to have MEA electrodes placed on the neck and bipolar electrodes placed on chest and stomach
Who cannot join
- Unable to provide consent
- Having gastric motility issues (not due to COVID 19) as determined by the PI or Sub-I
- Taking medications affecting gastric motility
- Anyone using cardiac pacemakers
- History of hemophilia
- History of psoriasis
Show all 11Show fewer
- Allergy to Sureprep
- Allergy to steri strip compound benzoin tincture
- Skin behind the ear is not healthy or not intact
- Pregnant females
- Prisoners
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Electrical Stimulation of the Auricular Branch of the Vagus Nerve (ABVN) on Cervical Vagus Nerve Action Potentials (CNAPs) Phase 2 - 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 2 grant is to expand on previous work evaluating 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 percutaneous electrical field stimulation on the vagus nerve in healthy subjects.
[This study was originally described in NCT06491758, however a separate record has been created to more accurately reflect the independence of the individual studies supported by the ABVN 2 grant.]
Read the detailed description
Healthy volunteer subjects will be recruited for this project, which will be completed at a single study visit.
When participants arrive, they will be fitted with:
- the PENFS device; placed behind the left ear using steri strips after the skin is cleansed using Sureprep (a medicinal wipe similar to an alcohol wipe)
- Multi-electrode array (MEA); which consists of 30 small, plastic electrocardiogram (ECG) like electrodes that stick to the skin and will be placed on either side of the neck area over the vagus nerve.
- ECG electrodes, placed on:
- on the chest and arms or legs (for measurement of the ECG)
- on the abdomen (to record the electrogastrogram, or EGG).
Participants will lie on their back and undergo a 20-minute baseline recording of vagal nerve activity. During the baseline recording, no current is delivered to the ear. Following the baseline recording, participants will undergo their randomly assigned experimental condition (either active stimulation delivered via the PENFS device, or no stimulation) for 20 minutes, After the experimental recording is completed, the device will be removed and participants will continue to lie on their back for 20 minutes of recovery.
Continuous vagal nerve, ECG, and EGG recordings are obtained during the baseline, experimental, and recovery rest periods.
- Conditions
- Healthy Subjects
- Being tested
- Percutaneous Electrical Nerve Field Stimulation (PENFS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Electrical Nerve Field Stimulation (PENFS)Device
Also called IB-Stim
The PENFS is a battery-operated micro-stimulation appliance weighing 5 grams designed as a disposable product for single use. It is placed behind the patient's ear and connected to stimulation needles on the auricle. The appliance transmits low-frequency electrical impulses.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Subjects - PENFS Stimulation | Active comparator | All participants will have the PENFS device placed, however, only participants randomized to active stimulation will have the device turned on for a period of 20 minutes (experimental phase). Receives: Device: Percutaneous Electrical Nerve Field Stimulation (PENFS) |
| Healthy Subjects - No PENFS Stimulation | Sham comparator | All participants will have the PENFS device placed, however, the device will not be turned on during the experimental phase for participants randomized to sham stimulation. Receives: Device: Percutaneous Electrical Nerve Field Stimulation (PENFS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with vagal nerve compound action potentials detected
The number of participants in whom vagal nerve compound action potentials are detected will be counted.
Measured: Day 1
Change in amplitude of vagal nerve compound action potentials
In participants with detectable vagal nerve compound action potentials, the change in amplitude of vagal nerve compound action potentials will be measured during percutaneous stimulation of the auricular branch of the vagal nerve.
Measured: Day 1
Number of participants with detectable changes in parasympathetic and sympathetic vagal nerve activity
The study will evaluate whether stimulation of the vagal nerve causes changes in parasympathetic and sympathetic nerve activity.
Measured: Day 1
Changes in amplitude of the surface electrogastrogram
To measure the changes of surface electrogastrogram during percutaneous stimulation of the auricular branch of the vagal nerve.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start8 Oct 2021
- Primary completion9 Jun 2022
- Study completion9 Jun 2022
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- 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
- NCT07856446
- Sponsor's protocol ID
- 2006075899-D
- Other IDs
- 1OT2OD028183-01
- Acronym
- ABVN2
- Status last verified
- Aug 2026
- First submitted
- 28 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified data may be shared with other researchers for similar purposes as to this study
Study at a glance
From the registry record, last updated by the sponsor on 2 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 Action Potentials (CNAPs) Phase 2 - Ear Stimulation
- ClinicalTrials.gov ID
- NCT07856446
- Acronym / sponsor ID
- ABVN2 / 2006075899-D
- 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
- 8 Oct 2021 (actual)
- Primary completion
- 9 Jun 2022 (actual)
- Study completion
- 9 Jun 2022 (actual)
- First posted
- 2 Oct 2026 (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 2 grant is to expand on previous work evaluating 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 percutaneous electrical field stimulation on the vagus nerve in healthy subjects.
[This study was originally described in NCT06491758, however a separate record has been created to more accurately reflect the independence of the individual studies supported by the ABVN 2 grant.]
Detailed description
Healthy volunteer subjects will be recruited for this project, which will be completed at a single study visit.
When participants arrive, they will be fitted with:
- the PENFS device; placed behind the left ear using steri strips after the skin is cleansed using Sureprep (a medicinal wipe similar to an alcohol wipe)
- Multi-electrode array (MEA); which consists of 30 small, plastic electrocardiogram (ECG) like electrodes that stick to the skin and will be placed on either side of the neck area over the vagus nerve.
- ECG electrodes, placed on:
- on the chest and arms or legs (for measurement of the ECG)
- on the abdomen (to record the electrogastrogram, or EGG).
Participants will lie on their back and undergo a 20-minute baseline recording of vagal nerve activity. During the baseline recording, no current is delivered to the ear. Following the baseline recording, participants will undergo their randomly assigned experimental condition (either active stimulation delivered via the PENFS device, or no stimulation) for 20 minutes, After the experimental recording is completed, the device will be removed and participants will continue to lie on their back for 20 minutes of recovery.
Continuous vagal nerve, ECG, and EGG recordings are obtained during the baseline, experimental, and recovery rest periods.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Subjects - PENFS Stimulation | Active comparator | Device: Percutaneous Electrical Nerve Field Stimulation (PENFS)All participants will have the PENFS device placed, however, only participants randomized to active stimulation will have the device turned on for a period of 20 minutes (experimental phase). |
| Healthy Subjects - No PENFS Stimulation | Sham comparator | Device: Percutaneous Electrical Nerve Field Stimulation (PENFS)All participants will have the PENFS device placed, however, the device will not be turned on during the experimental phase for participants randomized to sham stimulation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- No gastrointestinal symptoms or conditions
- Aged 18-80 years
- Willing to have electrodes placed in the external ear
- Willing to have MEA electrodes placed on the neck and bipolar electrodes placed on chest and stomach
Key exclusion criteria (11 listed)
- Unable to provide consent
- Having gastric motility issues (not due to COVID 19) as determined by the PI or Sub-I
- Taking medications affecting gastric motility
- Anyone using cardiac pacemakers
- History of hemophilia
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 |
|---|---|---|
| Percutaneous Electrical Nerve Field Stimulation (PENFS)Also: IB-StimThe PENFS is a battery-operated micro-stimulation appliance weighing 5 grams designed as a disposable product for single use. It is placed behind the patient's ear and connected to stimulation needles on the auricle. The appliance transmits low-frequency electrical impulses. | Device | Healthy Subjects - No PENFS Stimulation, Healthy Subjects - PENFS Stimulation |
Primary outcome
Number of participants with vagal nerve compound action potentials detected
Time frame: Day 1
The number of participants in whom vagal nerve compound action potentials are detected will be counted.
Change in amplitude of vagal nerve compound action potentials
Time frame: Day 1
In participants with detectable vagal nerve compound action potentials, the change in amplitude of vagal nerve compound action potentials will be measured during percutaneous stimulation of the auricular branch of the vagal nerve.
Number of participants with detectable changes in parasympathetic and sympathetic vagal nerve activity
Time frame: Day 1
The study will evaluate whether stimulation of the vagal nerve causes changes in parasympathetic and sympathetic nerve activity.
Changes in amplitude of the surface electrogastrogram
Time frame: Day 1
To measure the changes of surface electrogastrogram during percutaneous stimulation of the auricular branch of the vagal nerve.
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 2 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified data may be shared with other researchers for similar purposes as to this 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. 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 Percutaneous Electrical Nerve Field Stimulation (PENFS) 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 4 inclusion and 11 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 2 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?
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 compound action potentials detected (time frame: Day 1). The study lists 4 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 2 Oct 2026; AzTrials last refreshed its copy on 30 Oct 2026.