Cardiac Vagal Effects of Gastric Electrical Stimulation and Vagal Nerve Action Potentials in Vagus nerve in Patients with Gastroparesis- Randomized Phase

Study on a Device Used to Help Control Stomach Movements and Gastroparesis Symptoms

Recruiting
18 years - 100 years
All
Phase N/A
1 Location

Brief description of study.

The purpose of this study is to assess if the Gastric Electric Stimulator (GES) device may influence the vagal output, which helps in the relief of the symptoms of gastroparesis, mainly nausea and vomiting.

Detailed description of study

The primary objective is to find if Gastric electrical stumulation (GES) may influence the flow in the vagus nerve when the signals are sent by the GES. Specifically this study will determine whether programming the GES device to produce optimal CNAPs results in better resolution of symptoms than empiric increases in stimulus current and frequency.

Eligibility of study

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

  • Conditions: gastroparesis
  • Age: 18 years - 100 years
  • Gender: All

Inclusion Criteria
Documented diagnosis of gastroparesis
Already has a GES device implanted
Severity and frequency of nausea and vomiting to be rated more than mild
Exclusion Criteria
Pregnancy
History of allergic reaction to EKG leads placement adhesives

This study investigates the effects of a Gastric Electric Stimulator (GES) on symptoms of gastroparesis, which include nausea and vomiting. Gastroparesis is a condition where the stomach cannot empty food properly due to nerve or muscle problems. The study aims to see if the GES can influence the vagus nerve, which is important for controlling stomach movements.

Participants will have their GES device programmed to test different electrical signals. The study will compare the results of these programmed signals to see if they improve symptoms better than the usual adjustments made to the device.

  • Who can participate: Adults diagnosed with gastroparesis who already have a GES device implanted and experience more than mild nausea and vomiting can participate. Pregnant individuals and those with allergies to EKG lead adhesives are excluded.
  • Study details: Participants will undergo programming of their existing GES device to test different settings. The study will involve monitoring the effects of these settings on their symptoms.
Updated on 19 Feb 2024. Study ID: 1712391546

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