Status:
COMPLETED
Transcutaneous Electrical Acustimulation (TEA) for Gastroparesis
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Gastroparesis With Diabetes Mellitus
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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 ...
Detailed 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 participa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2025
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT05362578
Start Date
September 8 2022
End Date
February 28 2025
Last Update
September 2 2025
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109