Transcutaneous Electrical Acustimulation (TEA) for Gastroparesis

Completed · Not applicable · Has a placebo group

Conditions studied: Gastroparesis With Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT05362578

Run by

University of Michigan

People needed

41

Starts

2022-09-08

Expected to finish

2025-02-28

Last updated by the study team

2026-07-20

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• At least a 3-month history of diabetic gastroparesis symptoms on an on-going basis; at least one severe gastroparetic symptom or two moderate gastroparetic symptoms (e.g. vomiting, nausea, early satiety, bloating, or epigastric or abdominal pain) during the screening.
• Documented delayed gastric emptying within past 3 years
• Stable concomitant medications, defined as no changes in regimen for at least 2 weeks prior to the experiment (daily adjustments of insulin doses are permitted if patient has diabetes)

You may not qualify if…

• Currently receiving parenteral feeding or presence of a nasogastric or other enteral tube
• History of gastric surgery such as fundoplication, gastrectomy, or vagotomy
• Symptoms suggestive of gastroparesis with no diagnosis of diabetes
• Pregnancy or expect to conceive during the course of the study
• Uncontrolled diabetes mellitus (HbA1c > 11%).
• Having any implanted medical device, such as cardiac pacemaker or Entera device

Where it is running

• University of Michigan — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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