ABVN Phase 2 - PENFS

NCT07856446 | Completed DMC FDA Device

• 2 other identifiers: 2006075899-D1OT2OD028183-01
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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. 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. \[This study was originally described in NCT06491758, however a separate record has been created to more accurately reflect the independence of the individual studies supported by the ABVN 2 grant.\]

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Day 1

Study Arms (2)

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).

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.

Device: Percutaneous Electrical Nerve Field Stimulation (PENFS)

Interventions

Percutaneous Electrical Nerve Field Stimulation (PENFS) DEVICE

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

Healthy Subjects - No PENFS Stimulation; Healthy Subjects - PENFS Stimulation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Allergy to Sureprep
• Allergy to steri strip compound benzoin tincture
• Skin behind the ear is not healthy or not intact
• Pregnant females
• Prisoners

Sponsors & Collaborators

• Indiana University: lead
• Purdue University: collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Study Officials

• Thomas V Nowak, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 28, 2026
• First Posted: October 2, 2026
• Study Start: October 8, 2021
• Primary Completion: June 9, 2022
• Study Completion: June 9, 2022
• Last Updated: October 2, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR, ANALYTIC CODE
• Time Frame: Three years after study completion
• Access Criteria: None as of yet.

Locations

US (1)