An interventional study of Vagal Maneuvers in Gastroparesis, sponsored by Indiana University. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. 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 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.]
Patients with gastroparesis will be recruited for this project, which is expected 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.
When participants arrive, electrodes are placed over the right and left vagus nerve (to record vagal nerve activity), chest (to record electrocardiogram, or ECG) and stomach area (to record electrogastogram, or EGG). 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.
311 studies on the registry are indexed under Gastroparesis; 67 are open to participants now.
This study's enrollment of 33 is below the median of 42 across 205 interventional studies indexed under Gastroparesis.
Browse Gastroparesis studies →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:
Subjects with a confirmed diagnosis of gastroparesis.
Other: Vagal Maneuvers
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
Amplitude of vagal nerve compound action
To measure the amplitude of vagal nerve compound action potentials during vagal maneuvers.
Time frame: 3 hours
Respiratory Changes in heart rate during stimulation
To measure respiratory changes in heart rate during vagal maneuvers.
Time frame: 3 hours
Changes in amplitude of the surface electrogastrogram
To measure the changes of surface electrogastogram during vagal maneuvers.
Time frame: 3 hours
Plan to share: Yes — De-identified data may be shared with other researchers for similar purposes as to this study
Supporting information: Clinical study report, Analytic code
Time frame: Three years after study completion
Access criteria: None as of yet.
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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