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Vagus Nerve Stimulation in Healthy Subjects (ABVN1 Trial)

N/A
Recruiting
Led By Thomas V Nowak, MD
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged 18-80 years
Willing to have electrodes placed in the external ear (ABVN arm)
Must not have
Unable to provide consent
Taking medications affecting gastric motility
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether electrical stimulation of the vagus nerve can help with nausea and vomiting, and also to learn more about studying the vagus nerve.

Who is the study for?
This trial is for healthy volunteers aged 18-80 who are willing to have electrodes placed on their external ear and perform vagal maneuvers. It's not suitable for those unable to consent, pregnant women, prisoners, or individuals with gastric motility issues or on related medications.
What is being tested?
The study tests if stimulating the vagus nerve at the ear can affect stomach function. One method uses transcutaneous auricular stimulation; another involves performing specific maneuvers that activate the vagus nerve.
What are the potential side effects?
Potential side effects may include discomfort where electrodes are placed, dizziness during or after vagal maneuvers, and possible temporary changes in heart rate or digestive function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 80 years old.
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I am willing to have electrodes placed in my external ear.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am unable to give my consent for participation.
Select...
I am on medication that affects how my stomach moves food.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Amplitude of Vagus Nerve with Vagal Maneuvers
Amplitude of the Vagus nerve with ABVN
Secondary study objectives
EGG and ABVN
EGG and Vagal maneuver

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Healthy SubjectsExperimental Treatment2 Interventions
Healthy volunteers aged 18-80 years old who will undergo vagus nerve stimulation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vagal Stimulation
2023
N/A
~70
Transcutaneous Auricular Vagus Nerve Stimulation
2023
N/A
~210

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor
1,045 Previous Clinical Trials
1,316,854 Total Patients Enrolled
Purdue UniversityOTHER
233 Previous Clinical Trials
71,343 Total Patients Enrolled
Thomas V Nowak, MDPrincipal InvestigatorIndiana University
4 Previous Clinical Trials
402 Total Patients Enrolled

Media Library

ABVN stimulation Clinical Trial Eligibility Overview. Trial Name: NCT04206540 — N/A
Healthy Subjects Research Study Groups: Healthy Subjects
Healthy Subjects Clinical Trial 2023: ABVN stimulation Highlights & Side Effects. Trial Name: NCT04206540 — N/A
ABVN stimulation 2023 Treatment Timeline for Medical Study. Trial Name: NCT04206540 — N/A
Healthy Subjects Patient Testimony for trial: Trial Name: NCT04206540 — N/A
~3 spots leftby Aug 2025
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