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Vagus Nerve Stimulation in Healthy Subjects

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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am between 18 and 80 years old.
Select...
I am willing to have electrodes placed in my external ear.

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

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

Trial Design

1Treatment groups
Experimental Treatment
Group I: ABVN and Vagal ManeuversExperimental Treatment2 Interventions
There is only one arm and subjects can choose the intervention.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcutaneous Auricular Vagus Nerve Stimulation
2023
N/A
~160

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor
980 Previous Clinical Trials
982,952 Total Patients Enrolled
Purdue UniversityOTHER
224 Previous Clinical Trials
72,734 Total Patients Enrolled
Thomas V Nowak, MDPrincipal InvestigatorIndiana University
2 Previous Clinical Trials
90 Total Patients Enrolled

Media Library

ABVN stimulation Clinical Trial Eligibility Overview. Trial Name: NCT04206540 — N/A
Healthy Subjects Research Study Groups: ABVN and Vagal Maneuvers
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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people can participate in this experiment at most?

"Affirmative. The official records on clinicaltrials.gov demonstrate that this experiment, which was initiated in July 2019, is still recruiting individuals. They are aiming to find 30 participants from a single medical site."

Answered by AI

Are there still spots available for individuals to join this research endeavor?

"Affirmative. Information presented on clinicaltrials.gov verifies that this research is presently seeking participants, having first been published on July 22nd 2019 and most recently updated in December 18th 2019. 30 individuals are needed at a single medical facility for the study to be completed successfully."

Answered by AI

Does this clinical trial extend to octogenarians?

"The age requirement for participants of this trial is 18 and above, but not exceeding 80."

Answered by AI

What qualifications must someone meet in order to qualify for this research?

"This trial seeks 30 healthy individuals aged between 18 and 80 to participate. To be eligible, participants must meet the following criteria: Healthy volunteers, Aged 18-80 years, Agreeable to having sensors affixed on their outer ear (ABVN arm), Ready to perform a vagal activity test ( Vagal arm)."

Answered by AI

Who else is applying?

What state do they live in?
Indiana
What site did they apply to?
Indiana University Hosptial
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Very interested in the vagus nerve.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Effect of Stimulation on the Vagus Nerve
Thomas V. Nowak 2019. "Effect of Stimulation on the Vagus Nerve". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04206540.
~7 spots leftby Aug 2025
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