ABVN Phase 2-Studying the Effect of Stimulation on the Auricular Branch of the Vagal Nerve -B (ABVN2-B)

February 9, 2025 updated by: Thomas V. Nowak, Indiana University

Effect of Electrical Stimulation of the Auricular Branch of the Vagus Nerve (ABVN) on Cervical Vagus Nerve Action Potentials Phase 2 - VNS Seizure

The purpose of this study is to find out if manual stimulation of the vagus nerve is possible. The vagus nerve is a largely-internal nerve that controls many bodily functions, including stomach function. The hope is that electrically stimulating the nerve around the external ear will also stimulate the internal vagus nerve.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Device: vagal nerve stimulation

Detailed Description

The purpose of this study is to find out if it is possible to gain access to the vagus nerve which is largely an internal nerve that controls stomach function. The hope is to gain access to the internal vagus nerve by electrically stimulating the nerve around the external ear. If this is possible to do this then there is hope that this will help the treatment of patients with nausea and vomiting and disordered stomach function. Healthy subjects and subjects with gastroparesis will be recruited. Subjects will undergo transcutaneous stimulation of the auricular branch of the vagus nerve and also undergo blood draw before, after stimulation and later a third draw after a period of no stimulation. Healthy subjects will also undergo vagal maneuver using the Multi Array Electrodes (MEA). Subjects will also complete health history questionnaires.

Study Type

Interventional

Enrollment (Actual)

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Indiana
  - Indianapolis, Indiana, United States, 46202
    - Indiana University Hosptial

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Volunteers with no GI symptoms
Ages 18-80
Undergoing VNS Therapy as part of clinical treatment for focal or partial epilepsy or seizure
Willing to have MEA electrodes placed on the neck and bipolar electrodes placed on chest and stomach

Exclusion Criteria:

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
Pregnant females
Prisoners

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vagal Nerve Activation Time Frame: 3 hours	To measure the amplitude of vagal nerve compound action potentials in gastroparetic subjects with symptoms of nausea and vomiting with skin electrodes over right and left vagus nerve during ABVN stimulation and also during the vagal maneuvers phase	3 hours
Measure changes in chest diameter resulting from breathing Time Frame: 3 hours	To measure and evaluate respiratory variation of heart rate.	3 hours
Amplitude surface electrogastrogram Time Frame: 3 hours	To measure changes in the amplitude of the surface electrogastrogram during ABVN and also during the vagal maneuvers phase.	3 hours
Heart rate variability Time Frame: 3 hours	To measure the Heart rate variability(HRV), vagal nerve compound action potentials and electrogastrogram in subjects undergoing VNS Therapy for focal or partial seizures.	3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Collaborators

Purdue University

Investigators

Principal Investigator: Thomas V. Nowak, MD, Professor of Clinical Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 13, 2021

Primary Completion (Actual)

July 13, 2022

Study Completion (Actual)

July 13, 2022

Study Registration Dates

First Submitted

December 6, 2024

First Submitted That Met QC Criteria

February 9, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)