About 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.
Eligibility criteria
Qualifiers
Adults aged 18 years or older.
Diagnosed gastroparesis.
Implanted Enterra™ device for at least 8 weeks prior to enrollment.
Chronic daily abdominal pain of gastric origin lasting more than 2 months.
Disqualifiers
Daily opioid use.
Pregnancy or breastfeeding.
Abdominal pain not attributed to gastric/visceral origin.
Severe constipation or uncontrolled diabetes (HbA1c >10).
Trial design
Treatments tested in this trial
- Enterra™ neurostimulator
Treatment groups
Sponsors and collaborators
University of Louisville
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator