An interventional study of ML1101 Stimulus Isolator and Vagal Maneuver in Gastroparesis, sponsored by Indiana University. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-06.
Sponsored by Indiana University · Not applicable, Interventional, and Treatment
The purpose of this study is to find out if we can gain access to the vagus nerve which is largely an internal nerve that controls stomach function. We hope to gain access to the internal vagus nerve by electrically stimulating the nerve around the external ear. If we can do this then we hope that this will help our treatment of patients with nausea and vomiting and disordered stomach function
Subjects will undergo transcutaneous stimulation of the auricular branch of the vagus nerve and also undergo blood draw before, after stimulation and later a third draw after a period of no stimulation. Healthy subjects will also undergo vagal maneuver using the Multi Array Electrodes (MEA). Gastroparetic subjects will also undergo vagal maneuver using either the regular EKG electrodes or the MEA electrodes.
Subjects will also complete health history questionnaires.
307 studies on the registry are indexed under Gastroparesis; 68 are open to participants now.
This study's enrollment of 131 is above the median of 44 across 202 interventional studies indexed under Gastroparesis.
Browse Gastroparesis studies →Indiana University is the lead sponsor of 958 studies on the registry; 200 are open to participants now.
Of its 142 completed or terminated interventional studies of FDA-regulated products, 112 (79%) have results posted.
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Inclusion Criteria healthy volunteers
Inclusion Criteria gastroparesis subjects
Exclusion Criteria:
Subjects who have no gastric symptoms or conditions
Device: ML1101 Stimulus Isolator · Procedure: Vagal Maneuver
Subjects with a confirmed diagnosis of gastroparesis.
Device: ML1101 Stimulus Isolator · Procedure: Vagal Maneuver
Electrical stimulation electrodes will be placed on the ear with the intensity of the current being increased by 10 percent every 60 seconds, the subject will grade the intensity of the current on a scale of 0-10. Increasing of the current will occur until the subject reports a comfortable level. Once the target level has been achieved the stimulation will be delivered for 2 minutes.
Subjects will undergo the following procedures to stimulate the vagus nerve. * Cough: 6 to 8 forceful coughs * Cold stimulus: a washcloth soaked in ice water will be placed on the face for 10 seconds. * Carotid massage * Gagging: a tongue depressor will be inserted for 10 seconds into the mouth touching the back of the mouth. * 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. * Eating: Subjects will be asked to drink water ( 8oz or 1 cup) or/ and Ensure Original ( 8 oz or 1 cup) that has 220 calories after fasting overnight to see that effect on vagal activity during eating.
Amplitude of vagal nerve compound action
To measure the amplitude of vagal nerve compound action potentials during stimulation of the auricular branch of the vagal nerve and during vagal maneuvers.
Time frame: 3 hours
Respiratory Changes in heart rate during stimulation
To measure respiratory changes in heart rate during stimulation of the auricular branch of the vagal nerve and also during the vagal maneuvers phase.
Time frame: 3 hours
Changes in amplitude of the surface electrogastrogram
To measure the changes of surface electrogastogram during stimulation of the auricular branch of the vagal nerve and also during the vagal maneuvers phase.
Time frame: 3 hours.
Changes in gastric hormones
To measure the effect of stimulation of the auricular branch of the vagal nerve and/or of vagal maneuvers on gastric hormones.
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: Csr, Analytic code
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Indiana University