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

Not Applicable

Recruiting

• Conditions: Gastroparesis

• Registration Number: NCT06491758
• Lead Sponsor: Indiana University

Brief 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.

Study Timeline

• Study Start: 2020-06-02
• Study First Submitted: 2024-06-12
• Study First Submitted QC: 2024-07-03
• Study First Posted: 2024-07-09
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-09
• Last Update Posted: 2025-02-11
• Primary Completion: 2028-12
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

• Unable to provide consent
• Pregnant females
• Prisoners

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in gastric hormones	3 hours.	To measure the effect of stimulation of the auricular branch of the vagal nerve and/or of vagal maneuvers on gastric hormones.
Amplitude of vagal nerve compound action	3 hours	To measure the amplitude of vagal nerve compound action potentials during stimulation of the auricular branch of the vagal nerve and during vagal maneuvers.
Changes in amplitude of the surface electrogastrogram	3 hours.	To measure the changes of surface electrogastogram during stimulation of the auricular branch of the vagal nerve and also during the vagal maneuvers phase.
Respiratory Changes in heart rate during stimulation	3 hours	To measure respiratory changes in heart rate during stimulation of the auricular branch of the vagal nerve and also during the vagal maneuvers phase.

Trial Locations

Locations (1)

Indiana University; 🇺🇸 Indianapolis, Indiana, United States