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NCT Number: NCT06491758

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

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University

Indianapolis, Indiana, 46202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

healthy volunteers

  • 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

Inclusion criteria

gastroparesis subjects

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. Amplitude of vagal nerve compound action

    Time frame: 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.

  2. Respiratory Changes in heart rate during stimulation

    Time frame: 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.

  3. Changes in amplitude of the surface electrogastrogram

    Time frame: 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.

  4. Changes in gastric hormones

    Time frame: 3 hours.

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

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Official study title

Effect of Electrical Stimulation of the Auricular Branch of the Vagus Nerve (ABVN) on Cervical Vagus Nerve Action Potentials Phase 2

Acronym: ABVN2

Important dates

Study start
2020
Primary completion
2028
Study completion
2030
First posted
Jul 9, 2024
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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