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

Not Applicable

Recruiting

• Conditions: Gastroparesis
• Interventions: Other: abvn; Device: Gastroelectric Stimulator (GES); Other: PENFS- Percutaneous Electrical Nerve Field Stimulation; Device: TaVNS (Transcutaneous Auricular Vagal Nerve Stimulation) Device; Device: wrist worn Corsano Cardio Watch 287-2B)-

• 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

Arm && Interventions

Group	Intervention	Description
EDS- Ehlers Danlos Syndrome Arm	abvn	The PI and the research team would like to recruit subjects that have both the diagnosis of gastroparesis and EDS or EDS only to further study the effect of the stimulation on the heart rate variability. A total of 60 subjects will be enrolled. The next phase of the study would like to study the autonomic responses for EDS patients and matched controls using wearable watch device and transcutaneous stimulation of the auricular branch of the vagal nerve stimulation (TaVNS).
Total of 40 gastroparetic patients will be enrolled with diabetic and idiopathic patients.	Gastroelectric Stimulator (GES)	Investigators propose to study the effect on gastric hormone before, during and after auricular stimulation. The proposal is to enroll 30 healthy volunteers with no gastric symptoms to 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. This is based upon the results obtained in our previous IRB approved study where blood was drawn in patients who had gastric electrical stimulation device implanted. Blood was drawn to study the effects of stimulation on gastric hormones. (Cardiac Vagal Effects of Gastric Electrical Stimulation and Vagal Nerve Action Potentials in Vagus nerve in Patients with Gastroparesis- IRB 1206008988)
Insulin, Glucose and C-peptide Blood Draw Group of Gastroparetic Patients	Gastroelectric Stimulator (GES)	This arm part is also to enroll 40 gastroparetic subjects to undergo blood draw before, after transcutaneous stimulation of the auricular branch of the vagus nerve, and a third draw after a period of no stimulation. Blood Draws are to obtain levels of Insulin, Glucose, and C-peptide for: baseline, Experimental and Recovery.
GP subjects undergo vagal maneuver including food study with the bipolar EKG	abvn	This portion is to see if there is an effect on the stomach emptying after vagal nerve stimulation in Gastroparetic (GP)
The PENFS-percutaneous electrical field stimulation arm	PENFS- Percutaneous Electrical Nerve Field Stimulation	Using percutaneous electrical field stimulation (PENFS) on vagal nerve in healthy volunteers and study the effect on the compound actions, parasympathetic and sympathetic vagal nerve activity and gastric myoelectrical (EGG) activity. A total of 24 healthy volunteers will be enrolled in this pilot study.
GP subjects undergo vagal maneuver including food study with the bipolar EKG	TaVNS (Transcutaneous Auricular Vagal Nerve Stimulation) Device	This portion is to see if there is an effect on the stomach emptying after vagal nerve stimulation in Gastroparetic (GP)
25 subjects Healthy Subjects, but have undergone VNS Therapy	TaVNS (Transcutaneous Auricular Vagal Nerve Stimulation) Device	This portion is to see if there is an effect on the stomach emptying after vagal nerve stimulation (VNS) Therapy, for the treatment of partial or focal seizures will be recruited for the study.
The PENFS-percutaneous electrical field stimulation arm	abvn	Using percutaneous electrical field stimulation (PENFS) on vagal nerve in healthy volunteers and study the effect on the compound actions, parasympathetic and sympathetic vagal nerve activity and gastric myoelectrical (EGG) activity. A total of 24 healthy volunteers will be enrolled in this pilot study.
25 subjects Healthy Subjects, but have undergone VNS Therapy	abvn	This portion is to see if there is an effect on the stomach emptying after vagal nerve stimulation (VNS) Therapy, for the treatment of partial or focal seizures will be recruited for the study.
EDS- Ehlers Danlos Syndrome Arm	wrist worn Corsano Cardio Watch 287-2B)-	The PI and the research team would like to recruit subjects that have both the diagnosis of gastroparesis and EDS or EDS only to further study the effect of the stimulation on the heart rate variability. A total of 60 subjects will be enrolled. The next phase of the study would like to study the autonomic responses for EDS patients and matched controls using wearable watch device and transcutaneous stimulation of the auricular branch of the vagal nerve stimulation (TaVNS).

Primary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Indiana University; 🇺🇸 Indianapolis, Indiana, United States