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

NCT06827548 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2025-02-14

No results posted yet for this study

Summary

The purpose of this study is to find out if manual stimulation of the vagus nerve is possible. The vagus nerve is a largely-internal nerve that controls many bodily functions, including stomach function. The hope is that electrically stimulating the nerve around the external ear will also stimulate the internal vagus nerve.

Conditions

Interventions

DEVICE

vagal nerve stimulation

Cervical neck electrodes used in this part of the study will include the multi electrode array (MEA). The MEA can be placed on either side of the neck over the area of the vagus nerve to record any electrical activity that might occur during the baseline period. Two ECG electrodes are placed either one on each arm or on the chest for measurement of the electrocardiogram (ECG). Three ECG electrodes are placed on the abdomen in a line parallel to the longitudinal axis of the stomach to record the electrogastrogram (EGG). A onetime baseline recording will be made for 20 minutes after which the subject will be discharged from the study.

Sponsors & Collaborators

  • Purdue University

    collaborator OTHER

  • Indiana University

    lead OTHER

Principal Investigators

  • Thomas V. Nowak, MD · Professor of Clinical Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-13
Primary Completion
2022-07-13
Completion
2022-07-13
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06827548 on ClinicalTrials.gov