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High Resolution, Noninvasive Measurement and Functional Classification of Vagal Nerve Response Patterns in Relation to Gastroparesis Symptom Management using Gastric Electrical Stimulation Therapy

Investigating the Effects of Gastric Electrical Stimulation, a Device Sending Electrical Pulses to the Stomach, on the Vagus Nerve

Recruiting
18-80 years
All
Phase N/A

This study investigates how gastric electrical stimulation (GES) might influence the vagus nerve, a key nerve in the body that helps control the stomach and other organs. The purpose is to understand if changes in symptoms are related to how the GES affects this nerve, particularly through its fibers that send signals to the brain.

During the study, participants will complete questionnaires about their symptoms. They will have small sensors placed on their bodies to record heart activity. The study will involve turning the GES device on and off to see how it affects these recordings. A newer type of sensor will also be used on the neck to measure the nerve's response. Participants might be asked to perform actions like coughing or using cold to stimulate the vagus nerve.

  • Who can participate: Adults aged 18 to 80 with gastroparesis and an Enterra device can participate. Pregnant women are not eligible.
  • Study details: Participants will fill out symptom surveys and have sensors placed on their bodies to record data. They will experience changes in their GES settings and perform simple tasks to stimulate the vagus nerve. A placebo is not used.
Study details
    Gastric Electrical Stimulation
    gastric
    gastroparesis

NCT04207996

19 February 2024

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