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ABVN Phase 2-Studying the Effect of Stimulation on the Auricular Branch of the Vagal Nerve
Sponsor: Indiana University
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
Official title: Effect of Electrical Stimulation of the Auricular Branch of the Vagus Nerve (ABVN) on Cervical Vagus Nerve Action Potentials Phase 2
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
131
Start Date
2020-06-02
Completion Date
2030-12
Last Updated
2026-03-06
Healthy Volunteers
Yes
Conditions
Interventions
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.
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.
Locations (1)
Indiana University
Indianapolis, Indiana, United States