Transcutaneous Electrical Acustimulation (TEA) for Gastroparesis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-08

Study Completion Date

2025-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

TENS in Scleroderma

NCT06646913

Scleroderma Gastroparesis Systemic Sclerosis (SSc)

RECRUITING PHASE1

Indiana University Gastric Electrical Stimulation Registry

NCT05047289

Gastroparesis

ENROLLING_BY_INVITATION

Gastric Electrical Stimulation for Abdominal Pain in Gastroparesis

NCT04121325

Abdominal Pain

TERMINATED

Transcutaneous Electrical Nerve Stimulation for the Treatment of Premature Ejaculation

NCT06570512

Transcutaneous Electrical Nerve Stimulation Premature Ejaculation

COMPLETED NA

Effect of T6 Dermatome Electrical Stimulation on Gastroduodenal Motility in Healthy Volunteers

NCT03316105

Weight Loss

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gastroparesis With Diabetes Mellitus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Half of subjects will be randomized to the sham arm, and half will be randomized to the treatment arm.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

transcutaneous electrical accustimulation at treatment point.

Intervention Type DEVICE

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 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.

Group Type SHAM_COMPARATOR

transcutaneous electrical accustimulation at sham point.

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No