32 Participants NeededMy employer runs this trial

Gastric Electrical Stimulation for Gastroparesis

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Overseen ByThomas V Nowak, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Indiana University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how turning off a Gastric Electrical Stimulator (GES), a device used to manage gastroparesis, affects insulin and glucose levels in individuals with gastroparesis, a condition that slows stomach emptying. The study compares two groups: one with the device temporarily turned off and another with it left on. Eligible participants should have had a GES for at least three months, have gastroparesis, and not be using insulin for diabetes. As an unphased trial, this study provides a unique opportunity to contribute to understanding gastroparesis management and potentially improve future treatment options.

What prior data suggests that the Gastric Electrical Stimulator is safe for gastroparesis patients?

Research has shown that gastric electrical stimulation (GES) is generally safe for treating gastroparesis, a condition where the stomach takes longer to empty its contents. Studies have found that GES works well and is easy for patients to handle, with low complication rates during and after surgery, around 6.6% and 7.6%, respectively. Additionally, GES has proven safe even in special situations, such as during pregnancy. Overall, evidence supports GES as a reliable treatment option with a strong safety record.12345

Why are researchers excited about this trial?

Gastric Electrical Stimulation (GES) is unique because it offers a novel approach for treating gastroparesis, a condition that traditionally relies on medications, dietary changes, and sometimes surgical interventions. Unlike medications that primarily target symptoms by altering gastric motility or reducing nausea, GES uses electrical pulses to stimulate the stomach muscles directly, potentially enhancing gastric function more naturally. Researchers are excited about this method because it could provide relief for patients who don't respond well to current treatments, potentially improving quality of life by targeting the root issue of delayed gastric emptying.

What evidence suggests that the Gastric Electrical Stimulator is effective for gastroparesis?

Studies have shown that Gastric Electrical Stimulation (GES) can help people with gastroparesis, a condition where the stomach doesn't empty properly. Research indicates that GES can reduce symptoms like nausea and vomiting. For example, one study found that 87% of patients felt relief from their symptoms. Another study showed that GES improved overall symptom severity, quality of life, and reduced how often patients vomited. Although results can vary, many patients report feeling better after using GES. In this trial, participants will be divided into two groups: the OFF Group, where the GES device will be turned off during the experiment, and the SHAM Group, where the device will remain on to create the illusion of being turned off and back on.16789

Who Is on the Research Team?

TV

Thomas V Nowak, MD

Principal Investigator

IU School of Medicine/IU Health

Are You a Good Fit for This Trial?

This trial is for people with gastroparesis who have had a gastric electrical stimulator (GES) implanted for at least three months and are not taking insulin shots for diabetes.

Inclusion Criteria

I am at least 18 years old.
I have been diagnosed with gastroparesis.
I do not take prescribed insulin for diabetes.
See 3 more

Exclusion Criteria

I am not willing to give up to eight blood samples for the study.
I am not able to understand or agree to participate in this study.
Pregnancy
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

A 20-minute period during which GES is left ON at each patient's pre-study settings

20 minutes
1 visit (in-person)

Experimental

A 4-hour period during which the GES device is turned OFF, with blood samples taken at multiple intervals

4 hours
1 visit (in-person)

Recovery

A 20-minute period during which GES is turned back ON to the patient's pre-study settings

20 minutes
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the experimental procedure

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Gastric Electrical Stimulator

Trial Overview

Researchers will temporarily turn off the participant's GES device for up to four hours to see how it affects blood levels of insulin, C-peptide, GLP-1, and glucose. Heart activity will also be monitored during this time.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: The OFF GroupExperimental Treatment1 Intervention
Group II: SHAM GroupPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials
1,063
Recruited
1,182,000+

Citations

Gastric Electric Stimulation for Refractory Gastroparesis - PMC

In another study, favorable outcomes were reported in a cohort of 103 patients, with gastrectomy demonstrating 87% symptom improvement (nausea, vomiting, ...

Gastric Electrical Stimulation for the Treatment of ...

GES appears beneficial, with significant improvement in GI TSS, weekly vomiting frequency, gastric emptying study, and quality of life.

Gastric Electrical Stimulation

The evidence available from studies is insufficient to support that gastric electrical stimulation is effective for the treatment of patients ...

Gastric Electrical Stimulation

A 2017 meta-analysis of these 5 RCTs did not find a significant benefit of GES on the. Patients generally reported improved symptoms at follow-up whether or ...

Gastric Electrical Stimulation: Role and Clinical Impact on ...

A meta-analysis including up to 600 patients showed an improvement in total symptom severity score, nausea, vomiting, early satiety, and loss ...

Gastric Electrical Stimulation Improves Outcomes of ...

Gastric electrical stimulation is an effective and safe treatment for medically refractory gastroparesis. Surgery. 2008; 144:566-574. Full ...

Gastric Electrical Stimulation

1.1 “Current evidence on the efficacy and safety of gastric electrical stimulation for gastroparesis is adequate to support the use of this procedure with ...

Outcome of gastric electrical stimulator with and without ...

At 5 years, success rate was higher in patients with than without pyloromyotomy however not statistically significant (82% versus 62%, p = 0.066) ...

The Safety and Efficacy of Gastric Electrical Stimulation ...

This study aimed to determine the safety and efficacy of gastric electrical stimulation (GES) in pregnant patients with medically refractory ...