Gastric Electrical Stimulation for Gastroparesis
(HEAL Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
Gastroparesis is a disorder characterized by delayed gastric emptying and symptoms including nausea, vomiting, and abdominal pain. Gastric electrical stimulation (GES) using the implanted Enterra™ neurostimulator is FDA-approved to treat nausea and vomiting but its impact on abdominal pain has not been well studied. This study evaluates whether alternative programming parameters of the Enterra™ device can reduce abdominal pain in patients with gastroparesis. Participants with an existing Enterra™ device will be randomized to one of three stimulation settings and followed for assessment of pain, gastrointestinal symptoms, quality of life, and medication use.
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Run-in
Participants complete a two-week run-in period using their baseline clinical device settings
Randomized Treatment
Participants are randomly assigned to one of three gastric electrical stimulation parameter sets and remain on their assigned settings for eight weeks
Follow-up
Participants may select their preferred settings for an additional eight-week follow-up period
What Are the Treatments Tested in This Trial?
Interventions
- Gastric Electrical Stimulation
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
Short-cycle stimulation (0.3 seconds on / 0.2 seconds off; 0.24 ms pulse width; 100 Hz frequency; 4-6 mA amplitude) delivered for one hour every eight hours, with nominal settings used during remaining time.
Continuous 24-hour stimulation (3 seconds on / 2 seconds off; 0.33 ms pulse width; 14 Hz frequency; 15-20 mA amplitude).
Continuous 24-hour gastric electrical stimulation using participants' standard clinically prescribed Enterra™ settings.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Louisville
Lead Sponsor
National Institutes of Health (NIH)
Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
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