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

Last updated: February 9, 2025
Sponsor: Indiana University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gastroparesis

Treatment

TaVNS (Transcutaneous Auricular Vagal Nerve Stimulation) Device

PENFS- Percutaneous Electrical Nerve Field Stimulation

Vagal Maneuver

Clinical Study ID

NCT06491758
2006075899- A
  • Ages 18-80
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Eligibility Criteria

Inclusion

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 GIphysician

  • Have a formal diagnosis of gastroparesis or are seeing the GI physician for symptomsrelated 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

Exclusion Criteria:

  • Unable to provide consent

  • Pregnant females

  • Prisoners

Study Design

Total Participants: 120
Treatment Group(s): 7
Primary Treatment: TaVNS (Transcutaneous Auricular Vagal Nerve Stimulation) Device
Phase:
Study Start date:
June 02, 2020
Estimated Completion Date:
December 31, 2030

Study 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.

Connect with a study center

  • Indiana University

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

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