Gastric Electrical Stimulation for Gastroparesis
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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline
A 20-minute period during which GES is left ON at each patient's pre-study settings
Experimental
A 4-hour period during which the GES device is turned OFF, with blood samples taken at multiple intervals
Recovery
A 20-minute period during which GES is turned back ON to the patient's pre-study settings
Follow-up
Participants are monitored for safety and effectiveness after the experimental procedure
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
This group of subjects will have their GES interrogated and observed as well as having the device turned off for the duration of the experiment. The device will then be re-interrogated and turned back on at the end of the experiment.
This group of subjects will have their GES interrogated and observed yet will not have the device turned off for the duration of the experiment. The device will then be re-interrogated at the end of the experiment. This is to retain the illusion of the device being turned back on.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Indiana University
Lead Sponsor
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.
3.
univerahealthcare.com
univerahealthcare.com/documents/d/global/uni-prv-gastric-electrical-stimulationGastric Electrical Stimulation
The evidence available from studies is insufficient to support that gastric electrical stimulation is effective for the treatment of patients ...
4.
southcarolinablues.com
southcarolinablues.com/web/public/brands/medicalpolicyhb/external-policies/gastric-electrical-stimulation/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 ...
7.
myhealthplanner.com
myhealthplanner.com/web/public/brands/medicalpolicy/external-policies/gastric-electrical-stimulation/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 ...
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