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

Not Applicable

Completed

• Conditions: Gastro-Intestinal Disorder; Gastroparesis

• Registration Number: NCT06827548
• Lead Sponsor: Indiana University

Brief 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.

Detailed Description

The purpose of this study is to find out if it is possible to gain access to the vagus nerve which is largely an internal nerve that controls stomach function. The hope is to gain access to the internal vagus nerve by electrically stimulating the nerve around the external ear. If this is possible to do this then there is hope that this will help the treatment of patients with nausea and vomiting and disordered stomach function. Healthy subjects and subjects with gastroparesis will be recruited. 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). Subjects will also complete health history questionnaires.

Study Timeline

• Study Start: 2021-05-13
• Primary Completion: 2022-07-13
• Study Completion: 2022-07-13
• Study First Submitted: 2024-12-06
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-09
• Last Update Submitted: 2025-02-09
• Study First Posted: 2025-02-14
• Last Update Posted: 2025-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• Volunteers with no GI symptoms
• Ages 18-80
• Undergoing VNS Therapy as part of clinical treatment for focal or partial epilepsy or seizure
• Willing to have MEA electrodes placed on the neck and bipolar electrodes placed on chest and stomach

Exclusion Criteria

• Unable to provide consent
• Having gastric motility issues (not due to COVID 19) as determined by the PI or Sub I
• Taking medications affecting gastric motility
• Pregnant females
• Prisoners

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Vagal Nerve Activation	3 hours	To measure the amplitude of vagal nerve compound action potentials in gastroparetic subjects with symptoms of nausea and vomiting with skin electrodes over right and left vagus nerve during ABVN stimulation and also during the vagal maneuvers phase
Measure changes in chest diameter resulting from breathing	3 hours	To measure and evaluate respiratory variation of heart rate.
Amplitude surface electrogastrogram	3 hours	To measure changes in the amplitude of the surface electrogastrogram during ABVN and also during the vagal maneuvers phase.
Heart rate variability	3 hours	To measure the Heart rate variability(HRV), vagal nerve compound action potentials and electrogastrogram in subjects undergoing VNS Therapy for focal or partial seizures.

Trial Locations

Locations (1)

Indiana University Hosptial; 🇺🇸 Indianapolis, Indiana, United States