What side effects are associated with this type of intervention?

Electrical stimulation treatments for gastroparesis, such as the Transcutaneous Electrical Accustimulator (TEA), generally have mild side effects, including lightheadedness, tingling, and occasional discomfort at the stimulation site. Other common treatments for gastroparesis, such as gastric electrical stimulation, may cause infection, lead migration, and abdominal pain. Endoscopic and surgical interventions like G-POEM and pyloroplasty can have complications such as infection, bleeding, and, in rare cases, induce dumping syndrome. Overall, while these treatments can be effective, they are not without potential risks and side effects.

What prior FDA approvals exist?

The FDA has approved several pharmacologic treatments for gastroparesis, primarily focusing on prokinetic agents such as metoclopramide, which is recommended as the initial treatment. Domperidone and erythromycin are also used when patients do not respond to metoclopramide. For device-based therapies, while the Transcutaneous Electrical Accustimulator (TEA) is still under study, there is no specific mention of FDA-approved electrical stimulation devices for gastroparesis in the provided context. However, similar neuromodulation techniques are being explored for other conditions, indicating a potential future direction for gastroparesis treatment.

What other types of research exist?

Promising, novel alternatives to Transcutaneous Electrical Accustimulator (TEA) for gastroparesis patients include: 1) Transcutaneous Supraorbital Nerve Stimulation, which has shown efficacy in reducing pain intensity in migraine patients; 2) Remote Electrical Neuromodulation, which uses a smartphone-controlled armband to provide nonpainful electrical skin stimulation and has been effective in reducing acute migraine pain; 3) Transcranial Magnetic Stimulation (TMS), which has demonstrated pain relief in migraine patients and could potentially be adapted for gastrointestinal symptoms. These alternatives offer noninvasive options that leverage neuromodulation to manage symptoms.

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TEA for Gastroparesis

N/A

Recruiting

Led By Borko Nojkov, MD

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Be older than 18 years old

Must not have

Uncontrolled diabetes mellitus (HbA1c > 11%).

Symptoms suggestive of gastroparesis with no diagnosis of diabetes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up visit 1 and visit 2 at 8 weeks

Summary

This trial is testing a device that sends weak electrical currents to the leg and arm to help people with gastroparesis. The goal is to see if it can improve stomach movement and reduce digestive symptoms.

Who is the study for?

This trial is for people with gastroparesis, a condition where the stomach empties slowly. Participants must have had delayed gastric emptying in the last 3 years and stable medications for at least 2 weeks. They should experience ongoing severe or moderate symptoms like vomiting or bloating. Those with recent stomach surgery, uncontrolled diabetes, pregnancy plans during the study, or implanted medical devices cannot join.

What is being tested?

The trial tests a device called Transcutaneous Electrical Accustimulator (TEA) that delivers weak electrical currents to potentially improve digestive symptoms and gastric motility in gastroparesis patients. It involves two points of stimulation: one on the leg and another on the arm.

What are the potential side effects?

Possible side effects from TEA may include skin irritation at the site of electrode placement, discomfort from electrical stimulation, muscle twitching, lightheadedness during treatment sessions but are generally considered minimal.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had severe symptoms like vomiting or nausea for at least 3 months due to diabetic gastroparesis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My diabetes is not under control (HbA1c > 11%).

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I have symptoms like delayed stomach emptying but I am not diabetic.

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I have had surgery on my stomach.

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I am currently on tube feeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ visit 1 and visit 2 at 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~visit 1 and visit 2 at 8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and visit 1 and visit 2 at 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptoms Index-Daily Diary (ANMS GCSI-DD)

Secondary study objectives

Electrocardiogram (ECG)

Electrogastrogram (EGG)

Gastric accommodation

Other study objectives

36-Item Short Form Survey Instrument (SF-36) to measure quality of life (QOL)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Treatment groupExperimental Treatment1 Intervention

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 II: Sham groupPlacebo Group1 Intervention

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.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for gastroparesis include dietary modifications, pharmacologic treatments, and various forms of electrical stimulation. Dietary modifications aim to ease digestion by recommending small, frequent meals and easily digestible foods. Pharmacologic treatments, such as metoclopramide and erythromycin, work by enhancing gastric motility and reducing nausea. Electrical stimulation treatments, like gastric electrical stimulation (GES) and Transcutaneous Electrical Accustimulator (TEA), deliver electrical impulses to the stomach or specific points on the body to improve gastric motility and alleviate symptoms. These treatments are crucial for gastroparesis patients as they target the underlying issue of delayed gastric emptying, thereby reducing symptoms like nausea, vomiting, and abdominal pain, and improving overall quality of life.

A Systematic Review of the Therapeutic Role of Gastric Pacemakers in Adults With Gastroparesis.