Effect of Stimulation on the Vagus Nerve

NCT04206540 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 1809683671
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Amplitude of the Vagus nerve with ABVN

  measure the amplitude of vagal nerve compound action potentials in healthy volunteers with skin electrodes over right and left vagus nerve during ABVN stimulation

  3 years

• Amplitude of Vagus Nerve with Vagal Maneuvers

  measure the amplitude of vagal nerve compound action potentials in healthy volunteers with skin electrodes over right and left vagus nerve during Vagal Maneuvers.

  3 years

Secondary Outcomes (2)

• EGG and ABVN

  3 years

• EGG and Vagal maneuver

  3 years

Study Arms (1)

Healthy Subjects

EXPERIMENTAL

Healthy volunteers aged 18-80 years old who will undergo vagus nerve stimulation.

Device: Transcutaneous Auricular Vagus Nerve Stimulation; Procedure: Vagal Stimulation

Interventions

Transcutaneous Auricular Vagus Nerve Stimulation DEVICE

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.

Also known as: ML1101 Stimulus Isolator

Healthy Subjects

Vagal Stimulation PROCEDURE

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.

Also known as: Vagal Maneuvers

Healthy Subjects

Eligibility Criteria

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

You may qualify if:

• Healthy volunteers
• Aged 18-80 years
• Willing to have electrodes placed in the external ear (ABVN arm)
• Willing to perform vagal activity maneuver ( Vagal arm)

You may not qualify if:

• Unable to provide consent
• Having gastric motility issues as determined by the PI or Sub I
• Taking medications affecting gastric motility
• Pregnant females
• Prisoners

Sponsors & Collaborators

• Indiana University: lead
• Purdue University: collaborator

Study Sites (1)

Indiana University Hosptial

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Interventions

Vagus Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics

Study Officials

• Thomas V Nowak, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor and Principal Investigator

Study Record Dates

• First Submitted: December 18, 2019
• First Posted: December 20, 2019
• Study Start: July 22, 2019
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2027
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)