NCT06491758

ABVN Phase 2-Studying the Effect of Stimulation on the Auricular Branch of the Vagal Nerve

Effect of Electrical Stimulation of the Auricular Branch of the Vagus Nerve (ABVN) on Cervical Vagus Nerve Action Potentials Phase 2

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 131 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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.

Conditions

• Gastroparesis

Interventions

Type	Name	Description
DEVICE	ML1101 Stimulus Isolator	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.
PROCEDURE	Vagal Maneuver	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.

Timeline

• Start date: 2020-06-02
• Primary completion: 2028-12-01
• Completion: 2030-12-01
• First posted: 2024-07-09
• Last updated: 2026-03-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study