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

NCT06491758 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 2006075899- A
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

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

Conditions

Gastroparesis

Outcome Measures

Primary Outcomes (4)

• Amplitude of vagal nerve compound action

  To measure the amplitude of vagal nerve compound action potentials during stimulation of the auricular branch of the vagal nerve and during vagal maneuvers.

  3 hours

• Respiratory Changes in heart rate during stimulation

  To measure respiratory changes in heart rate during stimulation of the auricular branch of the vagal nerve and also during the vagal maneuvers phase.

  3 hours

• Changes in amplitude of the surface electrogastrogram

  To measure the changes of surface electrogastogram during stimulation of the auricular branch of the vagal nerve and also during the vagal maneuvers phase.

  3 hours.

• Changes in gastric hormones

  To measure the effect of stimulation of the auricular branch of the vagal nerve and/or of vagal maneuvers on gastric hormones.

  3 hours.

Study Arms (2)

Healthy Subjects

EXPERIMENTAL

Subjects who have no gastric symptoms or conditions

Device: ML1101 Stimulus Isolator; Procedure: Vagal Maneuver

Gastroparesis Subjects

EXPERIMENTAL

Subjects with a confirmed diagnosis of gastroparesis.

Device: ML1101 Stimulus Isolator; Procedure: Vagal Maneuver

Interventions

ML1101 Stimulus Isolator 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.

Gastroparesis Subjects; Healthy Subjects

Vagal Maneuver 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; Healthy Subjects

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unable to provide consent
• Pregnant females
• Prisoners

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Gastroparesis

Condition Hierarchy (Ancestors)

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

Study Officials

• Thomas V Nowak, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: July 9, 2024
• Study Start: June 2, 2020
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2030
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR, ANALYTIC CODE
• Time Frame: Three years after study completion
• Access Criteria: None as of yet.

Locations

US (1)