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

  • STATUS
    Recruiting
  • participants needed
    40
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Updated on 19 February 2024

Summary

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.

Description

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.

FAQ


Details
Condition Gastric Electrical Stimulation,gastric,gastroparesis
Age 18years - 80years
Clinical Study IdentifierNCT04207996
Last Modified on19 February 2024

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