Study of How the Enterra Medical Gastric Electrical Stimulator Helps Reduce Symptoms in Gastroparesis Investigating Brain, Heart, and Stomach Responses to Gastric Stimulation

What this Trial Is About

Researchers are studying the effects of gastric electrical stimulation in people with gastroparesis who have an implanted gastric electrical stimulator but continue to experience symptoms despite medication. The study aims to understand why some patients respond well to the stimulation with symptom relief while others do not. Specifically, it investigates two possible ways the stimulation might work by affecting brain and brainstem activity through parasympathetic vagal nerve activity, and by improving stomach function such as gastric accommodation. Participants include up to thirty adults with drug-resistant gastroparesis who have a gastric electrical stimulator implanted. They are divided into two groups responders who had substantial symptom improvement and non-responders with little improvement. The study uses tests like electroencephalography EEG to monitor brain activity, electrocardiography ECG to assess heart autonomic regulation, and gastric ultrasound to evaluate stomach responses. These measurements are taken during different stimulation intensities, before and after activating the stimulator, and after eating. During a single study day, participants undergo these tests to observe changes caused by the stimulation. Researchers compare brain signals, heart regulation, and stomach activity between responders and non-responders. The main outcome measure is brain evoked potentials during maximum stimulation, with additional secondary measures including EEG and ECG changes, gastric accommodation, tension, contraction frequency, and symptom assessments. The findings may help improve stimulation settings and patient selection for this therapy. The study concludes by October 2025.

Mechanisms of Action for the Enterra Medical Gastric Electrical Stimulator