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

NCT ID: NCT06491758

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-02
• Study Completion Date: 2030-12-31

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.

Conditions

Gastroparesis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Healthy Subjects

Subjects who have no gastric symptoms or conditions

Group Type: EXPERIMENTAL

ML1101 Stimulus Isolator

Intervention Type: DEVICE

Electrical stimulation electrodes will be placed on the ear with the intensity of the current being increased by 10 percent every 60 seconds, the subject will grade the intensity of the current on a scale of 0-10. Increasing of the current will occur until the subject reports a comfortable level. Once the target level has been achieved the stimulation will be delivered for 2 minutes.

Vagal Maneuver

Intervention Type: PROCEDURE

Subjects will undergo the following procedures to stimulate the vagus nerve.

• Cough: 6 to 8 forceful coughs
• Cold stimulus: a washcloth soaked in ice water will be placed on the face for 10 seconds.
• Carotid massage
• Gagging: a tongue depressor will be inserted for 10 seconds into the mouth touching the back of the mouth.
• Valsalva maneuver: subjects will will be asked to bear down as if they were having a bowel movement. They will be asked to blow through a mouthpiece that is hooked to a machine that measures how hard they are blowing.
• Eating: Subjects will be asked to drink water ( 8oz or 1 cup) or/ and Ensure Original ( 8 oz or 1 cup) that has 220 calories after fasting overnight to see that effect on vagal activity during eating.

Gastroparesis Subjects

Subjects with a confirmed diagnosis of gastroparesis.

Group Type: EXPERIMENTAL

ML1101 Stimulus Isolator

Intervention Type: DEVICE

Electrical stimulation electrodes will be placed on the ear with the intensity of the current being increased by 10 percent every 60 seconds, the subject will grade the intensity of the current on a scale of 0-10. Increasing of the current will occur until the subject reports a comfortable level. Once the target level has been achieved the stimulation will be delivered for 2 minutes.

Vagal Maneuver

Intervention Type: PROCEDURE

Subjects will undergo the following procedures to stimulate the vagus nerve.

• Cough: 6 to 8 forceful coughs
• Cold stimulus: a washcloth soaked in ice water will be placed on the face for 10 seconds.
• Carotid massage
• Gagging: a tongue depressor will be inserted for 10 seconds into the mouth touching the back of the mouth.
• Valsalva maneuver: subjects will will be asked to bear down as if they were having a bowel movement. They will be asked to blow through a mouthpiece that is hooked to a machine that measures how hard they are blowing.
• Eating: Subjects will be asked to drink water ( 8oz or 1 cup) or/ and Ensure Original ( 8 oz or 1 cup) that has 220 calories after fasting overnight to see that effect on vagal activity during eating.

Interventions

ML1101 Stimulus Isolator

Electrical stimulation electrodes will be placed on the ear with the intensity of the current being increased by 10 percent every 60 seconds, the subject will grade the intensity of the current on a scale of 0-10. Increasing of the current will occur until the subject reports a comfortable level. Once the target level has been achieved the stimulation will be delivered for 2 minutes.

Intervention Type: DEVICE

Vagal Maneuver

Subjects will undergo the following procedures to stimulate the vagus nerve.

• Cough: 6 to 8 forceful coughs
• Cold stimulus: a washcloth soaked in ice water will be placed on the face for 10 seconds.
• Carotid massage
• Gagging: a tongue depressor will be inserted for 10 seconds into the mouth touching the back of the mouth.
• Valsalva maneuver: subjects will will be asked to bear down as if they were having a bowel movement. They will be asked to blow through a mouthpiece that is hooked to a machine that measures how hard they are blowing.
• Eating: Subjects will be asked to drink water ( 8oz or 1 cup) or/ and Ensure Original ( 8 oz or 1 cup) that has 220 calories after fasting overnight to see that effect on vagal activity during eating.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Healthy volunteers with no gastric symptoms or conditions (except due to COVID 19)
• Aged 18-80 years
• Willing to have electrodes placed in the external ear (ABVN arm)
• Willing to perform vagal activity maneuver (Vagal arm)
• Willing to have 1 tablespoon (15 ml) of blood drawn at 3 time points

• Gastroparesis subjects with a confirmed diagnosis of gastroparesis from a GI physician
• Have a formal diagnosis of gastroparesis or are seeing the GI physician for symptoms related to gastroparesis
• Aged 18-80 years
• Willing to have electrodes placed in the external ear (ABVN arm)
• Willing to perform vagal activity maneuver (Vagal arm)
• Willing to have 1 tablespoon (15 ml) of blood drawn at 3 time points

Exclusion Criteria

• Unable to provide consent
• Pregnant females
• Prisoners

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Thomas V. Nowak

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas V Nowak, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

Indiana University

Indianapolis, Indiana, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Maureen Schilling, BS

Role: CONTACT

maschi@iu.edu

3172782064

Lainna Cohen, MSW

Role: CONTACT

larcohen@iu.edu

3172780621

Facility Contacts

Maureen Schilling, BS

Role: primary

maschi@iu.edu

317-278-2064

Lainna Cohen, MSW

Role: backup

larcohen@iu.edu

3172780621

Other Identifiers

2006075899- A

Identifier Type: -

Identifier Source: org_study_id