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

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 04 Aug 2024. Study ID: 1907095542

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