Transcutaneous Electrical Acustimulation (TEA) for Gastroparesis

Description

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.

Conditions

Gastroparesis with Diabetes Mellitus

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Study Overview

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Study Details

Study overview

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.

Wearable Transcutaneous Electrical Acustimulation for Gastroparesis

Transcutaneous Electrical Acustimulation (TEA) for Gastroparesis

Condition
Gastroparesis with Diabetes Mellitus
Intervention / Treatment

-

Contacts and Locations

Ann Arbor

University of Michigan, Ann Arbor, Michigan, United States, 48109

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * 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

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Michigan,

Borko Nojkov, MD, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

2025-03