Gastric Electrical Stimulation for Abdominal Pain in Patients With Gastroparesis
University of Louisville
Summary
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.
Description
This is a multicenter, randomized, double-blind, active-controlled, three-arm parallel clinical trial in adults with gastroparesis who have an implanted Enterra™ gastric neurostimulator. All participants will complete a two-week run-in period using their baseline clinical device settings prior to randomization. Participants will then be randomly assigned in a 1:1:1 ratio to one of three gastric electrical stimulation parameter sets: standard nominal parameters (active control), special short-cycle parameters, or modified Enterra parameters delivered continuously. Participants will remain on th…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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. * Average pain score ≥4 on a 0-10 scale. * Ability to provide informed consent. Exclusion Criteria: * Daily opioid use. * Pregnancy or breastfeeding. * Abdominal pain not attributed to gastric/visceral origin. * Severe constipation or uncontrolled diabetes (HbA1c \>10). * Other medical conditions that would interfere with study participation.
Interventions
- DeviceEnterra™ neurostimulator
Gastric Electrical Stimulation using implanted Enterra™ neurostimulator with protocol-specified programming parameters.
Location
- University of Louisville Clinical Trials UnitLouisville, Kentucky