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

NCT06827548 | Completed FDA Device

• 1 other identifier: 2006075899-B
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastro-Intestinal Disorder; Gastroparesis

Outcome Measures

Primary Outcomes (4)

• Vagal Nerve Activation

  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

  3 hours

• Measure changes in chest diameter resulting from breathing

  To measure and evaluate respiratory variation of heart rate.

  3 hours

• Amplitude surface electrogastrogram

  To measure changes in the amplitude of the surface electrogastrogram during ABVN and also during the vagal maneuvers phase.

  3 hours

• Heart rate variability

  To measure the Heart rate variability(HRV), vagal nerve compound action potentials and electrogastrogram in subjects undergoing VNS Therapy for focal or partial seizures.

  3 hours

Interventions

vagal nerve stimulation DEVICE

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.

Also known as: VNS Therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead
• Purdue University: collaborator

Study Sites (1)

Indiana University Hosptial

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Digestive System Diseases; Gastroparesis

Interventions

Vagus Nerve Stimulation

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics

Study Officials

• Thomas V. Nowak, MD

  Professor of Clinical Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Medicine

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: February 14, 2025
• Study Start: May 13, 2021
• Primary Completion: July 13, 2022
• Study Completion: July 13, 2022
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)