An interventional study of Vagal Maneuvers and Multi-Electrode Array (MEA) Recording in Healthy Subjects, sponsored by Indiana University. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Indiana University · Not applicable, Interventional, and Other
The vagus nerve is a nerve that controls many bodily functions, including stomach function. Investigators hope to be able to measure the activity of the vagus nerve when it is stimulated through simple physical techniques.
The overall purpose of the ABVN 1 grant is to evaluate the effects of noninvasive stimulation on vagal nerve function. This will be accomplished through several independent, but related, studies. In this study, investigators will evaluate the effect of vagal stimulation through simple physical techniques (vagal maneuvers) in healthy subjects.
[This study was originally described in NCT04206540, however a separate record has been created to more accurately reflect the independence of the individual studies supported by the ABVN 1 grant.]
Only healthy volunteer subjects will be recruited and studied for this project, which is expected to be completed over approximately 3 hours. If all procedures cannot be completed in a single visit, participants may return on a second day to complete them.
At the beginning of the study visit, electrodes are placed over the right and left vagus nerve, chest and stomach area. A 10 minute baseline recording of vagal nerve activity, electrocardiogram (ECG) and electrogastrogram (EGG) is then completed prior to beginning the vagal maneuvers.
Participants may be asked to perform any of the following maneuvers:
After performing a maneuver for 10 seconds, another 8 minutes of recording will be made before doing any additional maneuvers.
Participants may also be asked to perform one or more eating maneuvers after an overnight fast.
Maneuvers will be selected at the investigator's discretion and not all maneuvers will be completed. If both the water and Ensure eating maneuvers are selected, they will be completed at two separate visits.
Indiana University is the lead sponsor of 982 studies on the registry; 199 are open to participants now.
Of its 148 completed or terminated interventional studies of FDA-regulated products, 117 (79%) have results posted.
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Exclusion Criteria:
Healthy volunteers aged 18-80 years old who will perform vagal maneuvers.
Other: Vagal Maneuvers · Device: Multi-Electrode Array (MEA) Recording
Subjects will be asked to perform various maneuvers to stimulate the vagus nerve: * Cough: 6 to 8 forceful coughs over 5 to 10 seconds. * Cold stimulus to face: Have an ice cold wash cloth placed on their face for 10 seconds. * Carotid massage: While the neck is extended and the head is turned away from the side being massaged, pressure is applied underneath the angle of the jaw in a gentle circular motion for about 10 seconds. * Gagging: a tongue depressor is briefly inserted into the back of the mouth touching the back 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, they can blow through the barrel of a 10 ml syringe for 15-20 seconds. * Eating: Subjects will be asked to drink 8 ounces of water and/or Ensure Original after fasting overnight.
In some participants, cervical neck electrodes used during the eating tasks may include the multi electrode array (MEA). As an alternative to standard single ECG electrodes, the MEA can be placed on either side of the neck over the area of the vagus nerve to record a wider signal of electrical activity.
Number of Participants with Vagal Nerve Activation
The number of healthy volunteers in which vagal nerve compound action potentials (CNAPs) can be detected during transcutaneous stimulation of the auricular branch of the vagal nerve.
Time frame: Day 1
Number of participants with an increase in surface electrogastrogram amplitude
The amplitude of the surface electrogastrogram (EGG) in healthy volunteers will be measured at baseline and during vagal maneuvers to determine whether vagal maneuvers increase surface EGG amplitude.
Time frame: Day 1
Percent Change in Heart Rate Variability
This will be measured in SDNN (standard deviation of normal to normal intervals in the EKG). The participants' average SDNN during vagal maneuvers is compared with the average baseline SDNN as a percent change of SDNN.
Time frame: Day 1
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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