An interventional study of Percutaneous Electrical Nerve Field Stimulation (PENFS) in Healthy Subjects, sponsored by Indiana University. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-02.
Sponsored by Indiana University · Not applicable, Interventional, and Other
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.]
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:
ECG electrodes, placed on:
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.
Indiana University is the lead sponsor of 958 studies on the registry; 200 are open to participants now.
Of its 142 completed or terminated interventional studies of FDA-regulated products, 112 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria healthy volunteers:
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).
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.
Device: Percutaneous Electrical Nerve Field Stimulation (PENFS)
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.
Also known as: IB-Stim
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 1
Plan to share: Yes — De-identified data may be shared with other researchers for similar purposes as to this study
Supporting information: Csr, Analytic code
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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