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Effect of Stimulation on the Vagus Nerve

NCT04206540 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-03-06

No results posted yet for this study

Summary

The vagus nerve is a largely-internal 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 will help the treatment of patients with nausea and vomiting and disordered stomach function.

Investigators also hope to be able to measure the activity of the vagus nerve when it is stimulated in other ways. This could help investigators learn more about studying this nerve in the future.

Conditions

  • Healthy Subjects

Interventions

DEVICE

Transcutaneous Auricular Vagus Nerve Stimulation

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 of a scale 0-10. Electrical stimulation will be delivered for 2 minutes once the subject reports the maximum comfortable intensity.

PROCEDURE

Vagal Stimulation

Subjects will be asked to do the following in order to stimulate the vagus nerve: * Cough 6 to 8 forceful coughs * Have an ice cold wash cloth placed on their face for 10 seconds. * Carotid massage * Gagging: a tongue depressor is briefly inserted into the back of the mouth touching the bag of the throat. * Valsalva maneuver: Subjects will be asked to bear down as if having a bowel movement. They will be asked to blow through a mouthpiece that is hooked to a device that measures how hard they are blowing. Alternatively, we can have them blow through the barrel of a 10 ml syringe for 15-20 seconds. * Eating: Subjects will be asked to drink water and/or Ensure that has 220 calories after fasting overnight.

Sponsors & Collaborators

  • Purdue University

    collaborator OTHER

  • Indiana University

    lead OTHER

Principal Investigators

  • Thomas V Nowak, MD · Indiana University

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-22
Primary Completion
2026-08-31
Completion
2027-08-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04206540 on ClinicalTrials.gov