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Transcutaneous Electrical Acustimulation (TEA) for Gastroparesis

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Conditions

Gastroparesis With Diabetes Mellitus

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Wearable Transcutaneous Electrical Acustimulation for Gastroparesis

Quick Facts

Study Start:2022-09-08
Study Completion:2025-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05362578

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.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Documented delayed gastric emptying within past 3 years
  3. * 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)
  1. * Currently receiving parenteral feeding or presence of a nasogastric or other enteral tube
  2. * History of gastric surgery such as fundoplication, gastrectomy, or vagotomy
  3. * Symptoms suggestive of gastroparesis with no diagnosis of diabetes
  4. * Pregnancy or expect to conceive during the course of the study
  5. * Uncontrolled diabetes mellitus (HbA1c \> 11%).
  6. * Having any implanted medical device, such as cardiac pacemaker or Entera device

Contacts and Locations

Principal Investigator

Borko Nojkov, MD
PRINCIPAL_INVESTIGATOR
University of Michigan

Study Locations (Sites)

University of Michigan
Ann Arbor, Michigan, 48109
United States

Collaborators and Investigators

Sponsor: University of Michigan

  • Borko Nojkov, MD, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-08
Study Completion Date2025-02-28

Study Record Updates

Study Start Date2022-09-08
Study Completion Date2025-02-28

Terms related to this study

Additional Relevant MeSH Terms

  • Gastroparesis With Diabetes Mellitus