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 years - 80 years
All
Phase N/A
40 participants needed
1 Location

Brief description of study.

This study will help clarify if the improvement in the patients symptoms are related to the GES influencing the vagal outflow via vagal afferent fibers. This will help in finding the path of the vagus nerve in the neck and if the vagus nerve is affected by the gastric electrical stimulation.

Detailed description of study

Participants will complete a symptom survey questionnaire and Gastric Cardinal Symptom Index (GCSI) questionnaire. Various electrocardiography (ECG) electrodes will be placed on the body and a 5-10 minute recording made. Information from the GES will be taken, then the GES turned off and another 2-4 minute recording made.
A newer kind of electrode called an MEA device will be placed on either one, or both sides of the neck. A 5-10 minute recording will be made, information from the GES will be taken, then the GES turned off and another 2-4 minute recording made.
With the GES off, participants may be asked to stimulate the vagus nerve through coughing, carotid massage, valsalva maneuver, and/or cold stimulus.
During a separate visit, participants will again complete a symptom survey questionnaire and GCSI questionnaire. Both ECG and MEA electrodes will be placed and a 5-10 minute recording made. Settings and power levels of the GES will be adjusted and new recordings made. The GES will be reprogrammed to original settings before participants leave.
Participants will receive a $50 gift card after each study visit.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Gastric Electrical Stimulation,gastric,gastroparesis
  • Age: 18 years - 80 years
  • Gender: All

Gastroparetic patients between 18 and 80 years of age with a stimulator (enterra device placed).
Women who are pregnant will not be eligible.

Updated on 19 Feb 2024. Study ID: 1907095542

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.

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