Transcutaneous Electrical Acustimulation (TEA) for Gastroparesis

July 17, 2026 updated by: Borko Nojkov, University of Michigan

Wearable Transcutaneous Electrical Acustimulation for Gastroparesis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 participant will undergo two visits. There will be two total visits that each follow the same schedule. During the first visit, subjects will undergo a 3-in-1 gastric functional test which is a non-invasive method to assess the gastric motility and visceral pain. This test will entail an EGG, ECG, and water satiety drink test for gastric accommodation. Following the 3-in-1 gastric functional test, subjects will be randomized and trained on how to use the study device. Half of the patients will be assigned to the sham group and half will be assigned to the treatment group. Each group will undergo 8 weeks of treatment or 8 weeks of sham stimulation and will receive weekly calls from the study team to check for adverse events and study compliance. Following the first 8 week period, subjects will return to the study site to undergo visit two. This will follow the same format as visit 1. At this time, subjects will become unblinded. Those who received sham stimulation will be trained on the correct locations for each TEA device and will receive an additional 4 weeks of treatment with the device.

Note: The gastric emptying breathalyzer test (GEBT) was removed, and the two-day visits were shortened to one-day to improve patient recruitment and retention.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment group
Subjects will be trained to use the devices at the treatment points and will undergo the treatment twice per day for 8 weeks. Following the first 8 weeks, at visit two, the devices will be collected by the study team.
Device: transcutaneous electrical accustimulation at treatment point.
The transcutaneous electrical accustimulator (TEA) device administers a mild electrical shock through the skin, similar to acupuncture at a location previously seen to provide benefit. The precise distinction between sham and experimental accustimulation is not described upon registration to reduce unblinding risk, to maintain scientific integrity.
Sham Comparator: Sham group
Subjects will be trained to use the devices at sham points and will undergo sham stimulation for the first 8 weeks. At visit two, after unmasking, subjects will optionally be trained on the treatment points and may participate in treatment for 4 weeks.
Device: transcutaneous electrical accustimulation at sham point.
The transcutaneous electrical accustimulator (TEA) device administers a mild electrical shock through the skin, similar to acupuncture at a location which has not been shown to provide benefit. The precise distinction between sham and experimental accustimulation is not described upon registration to reduce unblinding risk, to maintain scientific integrity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptoms Index-Daily Diary (ANMS GCSI-DD)
Time Frame: Up to 84 days

The American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptoms Index-Daily Diary (ANMS GCSI-DD) symptom daily score was generated by summing the scores on each of five symptom items (nausea, early satiety, postprandial fullness, upper abdominal pain, and number of vomiting episodes), each ranging from 0 (none) to 4 (very severe) and then dividing by 5, that is the number of items within the gastroparesis related symptom score. The minimum score was 0 and the maximum score was 4. Higher numbers indicated greater symptom impact.

Scores will be compared from day 0 to day 84.
Up to 84 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
36-Item Short Form Survey Instrument (SF-36) to Measure Quality of Life (QOL)
Time Frame: 8 weeks
A 36-question assessment to score overall quality of life. The SF-36 consisted of eight health domains with questions, which were the weighted sums of the questions in their section. Each scale was directly transformed into a 0-100 scale on the assumption that each question carried equal weight. The scores from those domains were then averaged together for a final score within a full range of 0-100, with higher values indicating greater function and 100 representing the highest level of functioning possible.
8 weeks
Gastric Accommodation
Time Frame: 8 weeks
A water-satiety drink test was performed during which the participant was asked to drink at a speed of 60ml/min until reaching the maximum tolerable volume (MTV). Results reflect the maximum tolerable volume of the water-satiety drinking test.
8 weeks
Electrogastrogram (EGG)
Time Frame: Visit 1 and visit 2 at 8 weeks
EGG was performed twice at both the baseline and at the 8-week visit. One 30-minute EGG was performed prior to the gastric accommodation test, and one 30-minute EGG was performed after the nutrient drink test. The goal was to measure gastric slow waves, which act as an indirect measure of gastric transit time. The difference in slow waves was compared pre- and post- gastric accommodation. Slow waves were also compared between visit 1 and visit 2. The percentage of normal gastric slow waves was previously used to predict delayed gastric emptying in participants with gastroparesis. Higher percentage of normal slow waves suggests an improvement in gastric emptying.
Visit 1 and visit 2 at 8 weeks
Electrocardiogram (ECG) - High-frequency Power (HFn)
Time Frame: 8 weeks
ECG recorded while sitting 30 minutes b/f drinking (fasting) and 30 minutes after drinking water. Same procedure used at first visit (pretreatment) and second visit (post-treatment week 8). Goal was to measure autonomic function by calculating heart rate variability (HRV). Artifacts from recoded ECG signal were removed and R-peaks were detected. Time interval b/w successive R-peaks (RR interval) was calculated to generate HRV signal, which was used to calculate HRV parameters. Power w/i 0.15-0.40 Hz frequency band was defined as high-frequency (HF) power, while power w/i 0.04-0.15 Hz band was defined as low-frequency (LF) power. Normalized high-frequency power (HFn) was calculated as HFn = HF/HF+LF. HFn showed vagal/parasympathetic activity, with higher values indicating more active parasympathetic response and more responsive autonomic system. Pre-drinking (fasting) value of each HRV parameter at baseline (week 0) was compared to week 8 (after treatment) for both TEA and Sham groups.
8 weeks
Electrocardiogram (ECG) - Sympathetic Index (SI)
Time Frame: 8 weeks
The ECG was recorded in sitting position for 30 minutes before drinking (under fasting state) and 30 minutes after drinking water in sitting position. The same procedure was followed during first visit (pretreatment) and during the second visit (post-treatment week 8). The goal is to measure autonomic function via calculating the heart rate variability (HRV). The artifacts from the recoded ECG signal were removed and R-peaks were detected. The time interval between successive R peaks (the RR interval) was calculated to generate the HRV signal, which was used to calculate the HRV parameters. Sympathetic Index (SI) is HRV marker of Sympathetic Nervous system activity, with lower number meaning lower sympathetic activity and high numbers indicating greater sympathetic activity. The pre-drinking (fasting) value of each HRV parameter at baseline (week 0) was compared to that at week 8 (after treatment) for both TEA and Sham groups.
8 weeks
Electrocardiogram (ECG) - LFn/HFn Ratio
Time Frame: 8 weeks
The ECG was recorded in sitting position for 30 minutes before drinking (under fasting state) and 30 minutes after drinking water in sitting position. The same procedure was followed during first visit (pretreatment) and during the second visit (post-treatment week 8). The goal was to measure autonomic function via calculating the heart rate variability (HRV). The artifacts from the recoded ECG signal were removed and R-peaks were detected. The time interval between successive R peaks (the RR interval) was calculated to generate the HRV signal, which was used to calculate the HRV parameters. The LFn/HFn ratio reflects autonomic balance, with higher value indicating the autonomic balance shifts towards the sympathetic, which a lower value indicates that the autonomic balance shifts towards the parasympathetic. The pre-drinking (fasting) value of each HRV parameter at baseline (week 0) was compared to that at week 8 (after treatment) for both TEA and Sham groups.
8 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
36-Item Short Form Survey Instrument (SF-36) to Measure Quality of Life (QOL)
Time Frame: 12 weeks
A 36 question assessment to score overall quality of life. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)
National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: Borko Nojkov, MD, University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

September 8, 2022

Primary Completion (Actual)

February 28, 2025

Study Completion (Actual)

February 28, 2025

Study Registration Dates

First Submitted

March 31, 2022

First Submitted That Met QC Criteria

May 2, 2022

First Posted (Actual)

May 5, 2022

Study Record Updates

Last Update Posted (Actual)

July 20, 2026

Last Update Submitted That Met QC Criteria

July 17, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00204800
  • 5R44AT011380-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

De-identified individual participant data will not be shared. However, the study protocol and the study results will be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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