Transcutaneous Electrical Acustimulation (TEA) for Gastroparesis

Gastroparesis With Diabetes Mellitus Clinical Trial

Official title: Wearable Transcutaneous Electrical Acustimulation for Gastroparesis

Status Recruiting

Clinical Trial Summary

The device being studied, the Transcutaneous Electrical Accustimulator (TEA), will deliver weak electrical current at two specific points, one at the leg and the other at the arm at settings known to improve symptoms involving the digestive system. The study team would like to test if the device will impact the gastrointestinal (GI) symptoms and gastric motility in study participants with gastroparesis.

Clinical Trial Description

This study aims to assess if the device will impact the (GI) symptoms and gastric motility in study participants with gastroparesis. This will be done over a 12 week period during which each participant will undergo two visits. Each visit will take place over two days and both visits will follow the same schedule. During the first day, subjects will undergo a gastric emptying breath test which will be used to measure stomach emptying, which will last approximately 5 hours. During the second day, subjects will undergo a 3-in-1 gastric functional test which is a non-invasive method to assess the gastric motility and visceral pain. This test will entail an EGG, ECG, and nutrient drink test for gastric accommodation. Following the 3-in-1 gastric functional test, subjects will be randomized and trained on how to use the smartphone and the study device. Half of the patients will be assigned to the sham group and half will be assigned to the treatment group. Each group will undergo 8 weeks of treatment or 8 weeks of sham stimulation and will receive weekly calls from the study team to check for adverse events and study compliance. Following the first 8 week period, subjects will return to the study site to undergo visit two. This will follow the same two-day format as visit 1. At this time, subjects will become unblinded. Those who received sham stimulation will be trained on the correct locations for each TEA device and will receive 4 weeks of treatment with the device. ;

Related Conditions & MeSH terms

• Gastroparesis
• Gastroparesis With Diabetes Mellitus

• NCT number: NCT05362578
• Study type: Interventional
• Source: University of Michigan
• Contact: Colin Burnett
• Phone: 734-647-2806
• Email: bucolin@med.umich.edu
• Status: Recruiting
• Phase: N/A
• Start date: September 8, 2022
• Completion date: September 2024