[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635711":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":29,"centralContacts":30,"locations":36,"responsibleParty":51,"collaborators":55,"id":61,"slug":29,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":29,"enrollmentInfo":69,"targetDuration":29,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":79,"overallStatus":85,"whyStopped":29,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"University of Louisville","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Nominal GES Parameters","ACTIVE_COMPARATOR","Continuous 24-hour gastric electrical stimulation using participants' standard clinically prescribed Enterra™ settings.",[13],"Device: Enterra™ neurostimulator",{"label":15,"type":16,"description":17,"interventionNames":18},"Special Parameter GES","EXPERIMENTAL","Short-cycle stimulation (0.3 seconds on \u002F 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.",[13],{"label":20,"type":16,"description":21,"interventionNames":22},"Modified Enterra Parameters","Continuous 24-hour stimulation (3 seconds on \u002F 2 seconds off; 0.33 ms pulse width; 14 Hz frequency; 15-20 mA amplitude).",[13],[24],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DEVICE","Enterra™ neurostimulator","Gastric Electrical Stimulation using implanted Enterra™ neurostimulator with protocol-specified programming parameters.",[20,9,15],null,[31],{"name":32,"role":33,"phone":34,"phoneExt":29,"email":35},"Thomas L Abell, MD","CONTACT","502-588-4600","thomas.abell@louisville.edu",[37],{"facility":38,"status":29,"city":39,"state":40,"zip":41,"country":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"University of Louisville Clinical Trials Unit","Louisville","Kentucky","40202","United States",{"type":44,"coordinates":45},"Point",[46,47],-85.75941,38.25424,{"lat":47,"lon":46},[50],{"name":32,"role":33,"phone":34,"phoneExt":29,"email":35},{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"PRINCIPAL_INVESTIGATOR","Thomas Abell","Arthur M Schoen MD Chair in Gastroenterology",[56,59],{"name":57,"class":58},"National Institutes of Health (NIH)","NIH",{"name":60,"class":58},"National Institute of Neurological Disorders and Stroke (NINDS)","100635711",false,"NCT07556237","Gastric Electrical Stimulation for Abdominal Pain in Patients With Gastroparesis","HEAL","Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* Diagnosed gastroparesis.\n* Implanted Enterra™ device for at least 8 weeks prior to enrollment.\n* Chronic daily abdominal pain of gastric origin lasting more than 2 months.\n* Average pain score ≥4 on a 0-10 scale.\n* Ability to provide informed consent.\n\nExclusion Criteria:\n\n* Daily opioid use.\n* Pregnancy or breastfeeding.\n* Abdominal pain not attributed to gastric\u002Fvisceral origin.\n* Severe constipation or uncontrolled diabetes (HbA1c \\>10).\n* Other medical conditions that would interfere with study participation.","ALL","18 Years",{"count":70,"type":71},150,"ESTIMATED","INTERVENTIONAL",[74],"NA","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.",[77,78],"Gastroparesis","Chronic Abdominal Pain",[80,81,82,83,84],"Gastric Electrical Stimulation","Enterra","Visceral pain","Gastroparesis pain","Neuromodulation","NOT_YET_RECRUITING","2026-04-28",{"date":88,"type":89},"2026-05-04","ACTUAL",{"date":91,"type":71},"2026-07",{"date":93,"type":71},"2030-07",{"name":5,"class":6},1]