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Completed

NCT Number: NCT06827548

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

The purpose of this study is to find out if manual stimulation of the vagus nerve is possible. The vagus nerve is a largely-internal nerve that controls many bodily functions, including stomach function. The hope is that electrically stimulating the nerve around the external ear will also stimulate the internal vagus nerve.

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Key information

Conditions

Gastro-Intestinal Disorder Digestive System Diseases Gastrointestinal Diseases Gastroparesis 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 Hosptial

Indianapolis, Indiana, 46202, United States

About this study

The purpose of this study is to find out if it is possible to gain access to the vagus nerve which is largely an internal nerve that controls stomach function. The hope is to gain access to the internal vagus nerve by electrically stimulating the nerve around the external ear. If this is possible to do this then there is hope that this will help the treatment of patients with nausea and vomiting and disordered stomach function. Healthy subjects and subjects with gastroparesis will be recruited. 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). Subjects will also complete health history questionnaires.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Volunteers with no GI symptoms
  • Ages 18-80
  • Undergoing VNS Therapy as part of clinical treatment for focal or partial epilepsy or seizure
  • Willing to have MEA electrodes placed on the neck and bipolar electrodes placed on chest and stomach

Exclusion criteria

  • Unable to provide consent
  • Having gastric motility issues (not due to COVID 19) as determined by the PI or Sub I
  • Taking medications affecting gastric motility
  • Pregnant females
  • Prisoners

Treatment and study plan

Vagal nerve stimulation

Device

Cervical neck electrodes used in this part of the study will include the multi electrode array (MEA). The MEA can be placed on either side of the neck over the area of the vagus nerve to record any electrical activity that might occur during the baseline period.

Two ECG electrodes are placed either one on each arm or on the chest for measurement of the electrocardiogram (ECG).

Three ECG electrodes are placed on the abdomen in a line parallel to the longitudinal axis of the stomach to record the electrogastrogram (EGG).

A onetime baseline recording will be made for 20 minutes after which the subject will be discharged from the study.

Other names: VNS Therapy

Primary outcomes

  1. Vagal Nerve Activation

    Time frame: 3 hours

    To measure the amplitude of vagal nerve compound action potentials in gastroparetic subjects with symptoms of nausea and vomiting with skin electrodes over right and left vagus nerve during ABVN stimulation and also during the vagal maneuvers phase

  2. Measure changes in chest diameter resulting from breathing

    Time frame: 3 hours

    To measure and evaluate respiratory variation of heart rate.

  3. Amplitude surface electrogastrogram

    Time frame: 3 hours

    To measure changes in the amplitude of the surface electrogastrogram during ABVN and also during the vagal maneuvers phase.

  4. Heart rate variability

    Time frame: 3 hours

    To measure the Heart rate variability(HRV), vagal nerve compound action potentials and electrogastrogram in subjects undergoing VNS Therapy for focal or partial seizures.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Purdue University

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 - VNS Seizure

Acronym: ABVN2-B

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 14, 2025
Registry last updated
Feb 14, 2025

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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