Effect of Electrical Stimulation of the Auricular Branch of the Vagus Nerve (ABVN) on Cervical Vagus Nerve Compound Nerve Action Potentials(CNAPs)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Indiana University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Amplitude of Vagus Nerve with Vagal Maneuvers
Study Overview
Brief Summary
The vagus nerve is a largely-internal nerve that controls many bodily functions, including stomach function. Investigators hope that electrically stimulating the nerve around the external ear will also stimulate the internal vagus nerve. If it does, then investigators hope that this will help the treatment of patients with nausea and vomiting and disordered stomach function.
Investigators also hope to be able to measure the activity of the vagus nerve when it is stimulated in other ways. This could help investigators learn more about studying this nerve in the future.
Detailed Description
Only healthy volunteer subjects will be recruited and studied for this project. Volunteer subjects will undergo transcutaneous stimulation of the auricular branch of the vagus nerve (ABVN) to determine whether this modality will also produce cervical vagus nerve compound action potentials. Ear Stimulation Group
Another part of the study is to measure the vagal response to maneuvers which are known to stimulate the vagus nerve. The implementation of these vagal maneuvers will allow comparison of ABVN stimulation to traditional methods of vagal stimulation.- Vagal Maneuver Group
EAR STIMULATION GROUP:
This is a onetime visit only that involves baseline and test procedures.
Two MRI compatible electrodes will be placed in the auricle of the left ear, fixed by a plastic armature that wraps around the ear. The leads from the electrodes are connected to a stimulator.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy volunteers
- •Aged 18-80 years
- •Willing to have electrodes placed in the external ear (ABVN arm)
- •Willing to perform vagal activity maneuver ( Vagal arm)
Exclusion Criteria
- •Unable to provide consent
- •Having gastric motility issues as determined by the PI or Sub I
- •Taking medications affecting gastric motility
- •Pregnant females
Arms & Interventions
Healthy Subjects
Healthy volunteers aged 18-80 years old who will undergo vagus nerve stimulation.
Intervention: Transcutaneous Auricular Vagus Nerve Stimulation (Device)
Healthy Subjects
Healthy volunteers aged 18-80 years old who will undergo vagus nerve stimulation.
Intervention: Vagal Stimulation (Procedure)
Outcomes
Primary Outcomes
Amplitude of Vagus Nerve with Vagal Maneuvers
Time Frame: 3 years
measure the amplitude of vagal nerve compound action potentials in healthy volunteers with skin electrodes over right and left vagus nerve during Vagal Maneuvers.
Amplitude of the Vagus nerve with ABVN
Time Frame: 3 years
measure the amplitude of vagal nerve compound action potentials in healthy volunteers with skin electrodes over right and left vagus nerve during ABVN stimulation
Secondary Outcomes
- EGG and ABVN(3 years)
- EGG and Vagal maneuver(3 years)
Investigators
Thomas V. Nowak
Clinical Professor and Principal Investigator
Indiana University