Treatment group for Gastroparesis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Michigan, Ann Arbor, MI
Gastroparesis+1 More
transcutaneous electrical accustimulation at treatment point. - Device
Eligibility
18+
All Sexes
What conditions do you have?
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Study 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.

Eligible Conditions

  • Gastroparesis
  • Gastroparesis With Diabetes Mellitus

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Visit 1 and visit 2 at 8 weeks

12 weeks
36-Item Short Form Survey Instrument (SF-36) to measure quality of life (QOL)
8 weeks
Gastric accommodation
Gastric emptying
Day 84
Change in American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptoms Index-Daily Diary (ANMS GCSI-DD)
Week 8
Electrocardiogram (ECG)
Electrogastrogram (EGG)

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Treatment group
1 of 2
Sham group
1 of 2
Experimental Treatment
Non-Treatment Group

60 Total Participants · 2 Treatment Groups

Primary Treatment: Treatment group · Has Placebo Group · N/A

Treatment group
Device
Experimental Group · 1 Intervention: transcutaneous electrical accustimulation at treatment point. · Intervention Types: Device
Sham group
Device
ShamComparator Group · 1 Intervention: transcutaneous electrical accustimulation at sham point. · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: visit 1 and visit 2 at 8 weeks

Trial Background

Borko Nojkov, Clinical Lecturer - Specialty Gastroenterology, Internal Medicine
Principal Investigator
University of Michigan
Closest Location: University of Michigan · Ann Arbor, MI
Photo of university of michigan comprehensive cancer center  1Photo of university of michigan comprehensive cancer center  2Photo of university of michigan comprehensive cancer center  3
2022First Recorded Clinical Trial
4 TrialsResearching Gastroparesis
1003 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References