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Completed NCT05362578

Transcutaneous Electrical Acustimulation (TEA) for Gastroparesis

Conditions: Gastroparesis With Diabetes Mellitus

Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 41
Sponsor: University of Michigan

Location: University of Michigan Ann Arbor Michigan

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.

Eligibility Criteria

Inclusion Criteria: * 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) Exclusion Criteria: * 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05362578). StuddyBuddy aggregates publicly available trial information.