Mechanisms of Action for the Enterra Medical Gastric Electrical Stimulator

Launched by UNIVERSITY OF AARHUS · Aug 30, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how a surgically implanted device called a gastric electrical stimulator helps people with gastroparesis, a condition that makes it hard for the stomach to empty normally, leading to symptoms like nausea and vomiting. The researchers want to understand how the device works by looking at its effects on the brain and stomach. They will compare two groups of participants: those who experience significant relief from their symptoms (responders) and those who see little improvement (non-responders). By measuring brain activity, heart function, and stomach behavior before and after using the device, the team hopes to find out why some people benefit more than others.

To participate in this trial, you need to be at least 18 years old and have an implanted gastric electrical stimulator. You should also be able to read and understand Danish and have a certain level of symptom improvement based on a specific scale. If you join the study, you'll go through various tests in one day, including brain scans and heart monitoring, while using the stimulator. This research may help doctors tailor treatment better in the future and improve care for people with gastroparesis. If you have concerns about previous surgeries or certain health conditions, it's important to discuss those with the study team.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 18 and above
• • Able to read and understand Danish
• • Have an implanted gastric electrical stimulator for treating gastroparesis
• • Answering 0 or 1 (non-responders) or 3 or 4 (responders) on the Likert scale describing the symptom improvement gained by gastric electrical stimulation.
• • Personally signed and dated the informed consent documents ("Informeret samtykke") indicating that the patient has been informed of all pertinent aspects of the trial
• • Are willing and able to comply with the scheduled visit and trial procedures
• Exclusion Criteria:
• • Previous surgery on the vagus nerve, including cervical vagotomy
• • Prior thoracic, abdominal or brain surgeries that, in the opinion of the investigator, could limit data collection or interpretation.
• • Previous diagnosis or history of orthostatic intolerance, e.g. POTS, neurocardiogenic syncope, orthostatic hypotension or autonomic dysfunction.
• • Patients with an implanted cardiac device (e.g. pacemaker, CRT, etc.) or vagal nerve stimulator (VNS).
• • History of neurological disease that, in the opinion of the investigator, could limit data collection or interpretation.
• • Participants with any clinical abnormalities that, in the opinion of the investigator, may increase the risk associated with trial participation or may interfere with the interpretation of the trial results