NCT07881289|CompletedDMC
ABVN Phase 2 - Vagal Maneuvers
ABVN2
Effect of Electrical Stimulation of the Auricular Branch of the Vagus Nerve (ABVN) on Cervical Vagus Nerve Action Potentials Phase 2 - Vagal Maneuvers
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ABVN2
Effect of Electrical Stimulation of the Auricular Branch of the Vagus Nerve (ABVN) on Cervical Vagus Nerve Action Potentials Phase 2 - Vagal Maneuvers
Sponsor study identifier
Secondary identifiers
interventional
33
1 country
1
Study Start
November 24, 2020
Actual (reported)Primary Completion
March 25, 2022
Actual (reported)Study Completion
March 25, 2022
Actual (reported)The vagus nerve is a nerve that controls many bodily functions, including stomach function. Investigators want to evaluate the effects of noninvasive stimulation of the auricular branch of the vagal nerve (ABVN) on vagal nerve function. The purpose of the ABVN Phase 2 grant is to expand on previous work evaluating vagally mediated compound nerve action potentials (CNAPs). 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 subjects with gastroparesis. \[This study was originally described in NCT06491758, however a separate record has been created to more accurately reflect the independence of the individual studies supported by the ABVN 2 grant.\]
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 25, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 24, 2020
Actual (reported)March 25, 2022
Actual (reported)March 25, 2022
Actual (reported)October 12, 2026
Actual (reported)October 19, 2026
Actual (reported)Amplitude of vagal nerve compound action
To measure the amplitude of vagal nerve compound action potentials during vagal maneuvers.
3 hours
Respiratory Changes in heart rate during stimulation
To measure respiratory changes in heart rate during vagal maneuvers.
3 hours
Changes in amplitude of the surface electrogastrogram
To measure the changes of surface electrogastogram during vagal maneuvers.
3 hours
Subjects with a confirmed diagnosis of gastroparesis.
Subjects will be asked to perform various maneuvers to stimulate the vagus nerve: * Cough: Produce 6 to 8 forceful coughs over 5 to 10 seconds * Cold stimulus to face: Have an ice cold washcloth placed on their face for 10 seconds. * Carotid massage: While the neck is extended and the head 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 mouth touching the back of the throat. * Valsalva maneuver: subjects will will be asked to bear down as if they were having a bowel movement. They will be asked to blow through a mouthpiece that is hooked to a machine 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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Indiana University
Indianapolis, Indiana, 46202, United States
Thomas V Nowak, MD
Indiana University
33 participants (actual enrollment reported by the registry).
First Submitted
October 12, 2026
First Posted
October 19, 2026
Study Start
November 24, 2020
Actual (reported)A Study to Evaluate the Safety and Tolerability of Virtual Reality to Treat Gastroparesis
Contact the study team to confirm eligibility.
Primary Completion
March 25, 2022
Actual (reported)Study Completion
March 25, 2022
Actual (reported)Last Updated
October 19, 2026
Record last verified: 2026-08
De-identified data may be shared with other researchers for similar purposes as to this study
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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