[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635711":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":29,"centralContacts":30,"locations":36,"responsibleParty":52,"collaborators":56,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":29,"enrollmentInfo":71,"targetDuration":29,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":81,"overallStatus":87,"whyStopped":29,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"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,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"University of Louisville Clinical Trials Unit","Louisville","Kentucky","40202","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-85.75941,38.25424,{"lat":48,"lon":47},[51],{"name":32,"role":33,"phone":34,"phoneExt":29,"email":35},{"type":53,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"PRINCIPAL_INVESTIGATOR","Thomas Abell","Arthur M Schoen MD Chair in Gastroenterology",[57,60],{"name":58,"class":59},"National Institutes of Health (NIH)","NIH",{"name":61,"class":59},"National Institute of Neurological Disorders and Stroke (NINDS)","100635711","gastric-electrical-stimulation-for-abdominal-pain-in-patients-with-gastroparesis-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":72,"type":73},150,"ESTIMATED","INTERVENTIONAL",[76],"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.",[79,80],"Gastroparesis","Chronic Abdominal Pain",[82,83,84,85,86],"Gastric Electrical Stimulation","Enterra","Visceral pain","Gastroparesis pain","Neuromodulation","NOT_YET_RECRUITING","2026-04-28",{"date":90,"type":91},"2026-05-04","ACTUAL",{"date":93,"type":73},"2026-07",{"date":95,"type":73},"2030-07",{"name":5,"class":6},1]