[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576300":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":50,"responsibleParty":68,"collaborators":44,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":44,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":44,"overallStatus":92,"whyStopped":44,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Indiana University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ACTIVE (electrical charge)","ACTIVE_COMPARATOR","The PENFS device is placed behind the patient's left ear and connected to stimulation needles on the auricle. The appliance transmits low-frequency electrical impulses throughout the auricle.",[13],"Device: PERCUTANEOUS ELECTRICAL FIELD NERVE STIMULATION",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham percutaneous electrical nerve field stimulation (no electrical charge)","SHAM_COMPARATOR","The PENFS device is placed behind the patient's left ear and connected to stimulation needles on the auricle. The appliance will not transmit any electrical impulses.",[19],"Device: Sham percutaneous electrical nerve field stimulation",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","PERCUTANEOUS ELECTRICAL FIELD NERVE STIMULATION","The IB-Stim is a percutaneous electrical nerve field stimulator (PENFS) system intended to be used in patients 11-18 years of age with functional abdominal pain associated with irritable bowel syndrome (IBS). The IB-Stim is intended to be used for 120 hours per week up to 3 consecutive weeks, through application to branches of Cranial Nerves V, VII, IX and X, and the occipital nerves identified by transillumination, as an aid in the reduction of pain when combined with other therapies for IBS.",[9],[27],"IB-STIM",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Sham percutaneous electrical nerve field stimulation","SHAM (no electrical charge)",[15],[33],"Sham arm",[35],{"name":36,"affiliation":37,"role":38},"Thomas V Nowak, MD","IU School of Medicine\u002FIU Health","PRINCIPAL_INVESTIGATOR",[40,46],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},"Maureen Schilling, BS","CONTACT","317-278-2064",null,"maschi@iu.edu",{"name":47,"role":42,"phone":48,"phoneExt":44,"email":49},"Lainna Cohen, MSW","3172780621","larcohen@iu.edu",[51],{"facility":52,"status":44,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Indiana University Hospital","Indianapolis","Indiana","46202","United States","US",{"type":59,"coordinates":60},"Point",[61,62],-86.15804,39.76838,{"lat":62,"lon":61},[65,66,67],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},{"name":47,"role":42,"phone":48,"phoneExt":44,"email":49},{"name":36,"role":38,"phone":44,"phoneExt":44,"email":44},{"type":38,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":44,"oldOrganization":44},"Thomas V. Nowak","Professor of Clinical Medicine","100576300","effect-of-percutaneous-electrical-nerve-field-stimulation-on-symptom-controlnervous-system-activity-in-patients-wdiabetes-types-12-100576300",false,"NCT06783504","Effect Of Percutaneous Electrical Nerve Field Stimulation on Symptom Control\u002FNervous System Activity in Patients w\u002FDiabetes Types 1\u002F2","Effect Of Percutaneous Electrical Nerve Field Stimulation (PENFS) On Symptom Control And Autonomic Nervous System Activity In Patients With Diabetes Mellitus","PENFS","Inclusion Criteria:\n\n* Wiling to have one teaspoon (5 ml) of blood drawn.\n* Diagnosed with gastroparesis for twelve months or longer\n* Diagnosed with diabetes either Type 1 or Type 2\n* Documented delayed gastric emptying (\\>10% retention of the test meal at four hours) on a standardized scrambled-egg scintigraphy gastric emptying test performed in the last two years.\n* Upper GI endoscopy indicating no mechanical obstruction performed in the last five years.\n* Symptoms of nausea and vomiting consistent with clinical diagnosis of gastroparesis (as opposed to other causes of nausea and vomiting such as mechanical obstruction, acute viral illness, chemotherapy, psychogenic vomiting.\n* Documented Hb A1c within three months of screening or at the time of screening (\\\u003C=8.0)\n\nExclusion Criteria:\n\n* Unable to provide consent\n* Pregnant females\n* Medical records indicate intestinal pseudo-obstruction\n* Diagnosed with cardiac arrhythmia\n* History of prior gastric surgery\n* History of vagotomy\n* History of organ transplantation\n* History of seizures\n* Diagnosed with primary swallowing disorders\n* Subjects who are dependent on drugs like Marinol for their condition\n* Those diagnosed with psychogenic vomiting and not related to gastroparesis\n* Medically unstable subjects\n* Those at high surgical risk\n* Subjects taking narcotic analgesics daily.\n* Those with poorly controlled diabetes mellitus (Hgb A1c\\>8) within three months of screening or at the time of screening.\n* Subjects diagnosed with hemophilia, psoriasis vulgaris are excluded\n* Those having a cardiac pacemaker will be excluded from the study.","ALL","18 Years","60 Years",{"count":83,"type":84},60,"ESTIMATED","INTERVENTIONAL",[87],"NA","The purpose of this study is to find out if we can stimulate the vagus nerve. The vagus nerve is a largely internal nerve that controls many bodily functions, including stomach function. We hope that electrically stimulating the nerve around the external ear will also stimulate the internal vagus nerve. If it does, then we hope that this will help our treatment of patients with nausea and vomiting and disordered stomach function.",[90,91],"Diabetes","Gastroparesis","NOT_YET_RECRUITING","2026-04-28",{"date":95,"type":96},"2026-04-29","ACTUAL",{"date":98,"type":84},"2027-02-10",{"date":100,"type":84},"2029-08",{"name":5,"class":6},1]