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COMPLETED
NCT06491758
NA

ABVN Phase 2 - Ear Stimulation

Sponsor: Indiana University

View on ClinicalTrials.gov

Summary

The vagus nerve is a nerve that controls many bodily functions, including stomach function. Investigators hope that electrically stimulating the nerve around the external ear will also stimulate the internal vagus nerve. If it does, then investigators hope that this may lead to additional treatment options for patients with nausea and vomiting and disordered stomach function. The overall purpose of the ABVN Phase 2 grant is to expand on previous work evaluating the effects of noninvasive stimulation on vagal nerve function. This will be accomplished through several independent, but related, studies. In this study, investigators will evaluate the effect of transcutaneous electrical stimulation of the vagus nerve on vagal nerve CNAPs and gastric hormones in healthy subjects and in subjects with gastroparesis.

Official title: Effect of Electrical Stimulation of the Auricular Branch of the Vagus Nerve (ABVN) on Cervical Vagus Nerve Action Potentials (CNAPs) Phase 2 - Ear Stimulation

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

34

Start Date

2020-11-05

Completion Date

2022-03-22

Last Updated

2026-10-16

Healthy Volunteers

Yes

Interventions

DEVICE

ML1101 Stimulus Isolator

Electrical stimulation of the vagus nerve around the external ear using a transcutaneous device. Electrical current will be increased or decreased in intensity based on subject feedback. Once the target level has been achieved the stimulation will be delivered for 2 minutes.

Locations (1)

Indiana University

Indianapolis, Indiana, United States