[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654203":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":32,"studyPopulation":32,"armGroups":40,"interventions":47,"overallOfficials":55,"centralContacts":59,"locations":68,"responsibleParty":84,"collaborators":32,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":32,"eligibilityCriteria":93,"healthyVolunteers":89,"sex":94,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":32,"studyType":100,"phases":101,"briefSummary":102,"conditions":103,"keywords":106,"overallStatus":70,"whyStopped":32,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Nationwide Children's Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":32},[9,13],{"measure":10,"description":11,"timeFrame":12},"Treatment Adherence Rate","Description: Percentage of the 28 prescribed intervention days with recorded Sparrow Link device use, calculated from device logs.","During the 4-week intervention period.",{"measure":14,"description":15,"timeFrame":16},"Study completion rate","Percentage of enrolled participants who complete the 8-week study.","From enrollment through week 8.",[18,22,26,29],{"measure":19,"description":20,"timeFrame":21},"Change in Pain Frequency, Severity, and Duration","Pain Frequency-Severity-Duration Scale measures pain frequency from 0-7 days per week, usual and worst pain from 0-10, and pain duration. Higher pain scores indicate worse symptoms.","Baseline through week 8",{"measure":23,"description":24,"timeFrame":25},"Change in Pediatric Quality of Life","Change in Pediatric Quality of Life Inventory score; higher scores indicate better quality of life.","Baseline through week 8.",{"measure":27,"description":28,"timeFrame":25},"Change in Anxiety","Change in the State-Trait Anxiety Inventory for Children score; higher scores indicate greater anxiety.",{"measure":30,"description":31,"timeFrame":25},"Change in Bristol Stool Form Scale","Average stool form over the previous week, rated from Type 1 to Type 7.",null,{"allocation":34,"interventionModel":35,"interventionModelDescription":36,"primaryPurpose":37,"observationalModel":32,"timePerspective":32,"maskingInfo":38},"NA","SINGLE_GROUP","Single-group, open-label pilot treatment study. All participants receive active transcutaneous auricular neurostimulation using the Sparrow Link device for at least one hour daily for 4 weeks. There is no randomization or control group.","TREATMENT",{"masking":39,"maskingDescription":32,"whoMasked":32},"NONE",[41],{"label":42,"type":43,"description":44,"interventionNames":45},"Transauricular neurostimulation","EXPERIMENTAL","All participants receive active transcutaneous auricular neurostimulation using the Sparrow Link device for at least one hour daily for 4 weeks, with follow-up assessments through week 8.",[46],"Device: Transcutaneous auricular neurostimulation",[48],{"type":49,"name":50,"description":51,"armGroupLabels":52,"otherNames":53},"DEVICE","Transcutaneous auricular neurostimulation","Participants will use the wearable Sparrow Link device for at least one hour daily for 4 weeks. Self-adhesive electrodes placed on and around the ear deliver noninvasive electrical stimulation. Region 1 uses 30 Hz with a 500-microsecond pulse width, and Region 2 uses 100 Hz with a 250-microsecond pulse width. The duty cycle is 5 minutes on and 10 seconds off. Amplitude ranges from 0 to 5.0 mA and is adjusted to a comfortable level.",[42],[54],"Sparrow Link",[56],{"name":57,"affiliation":5,"role":58},"Peter Lu, MD","PRINCIPAL_INVESTIGATOR",[60,64],{"name":57,"role":61,"phone":62,"phoneExt":32,"email":63},"CONTACT","(614) 722-3421","Peter.Lu@nationwidechildrens.org",{"name":65,"role":61,"phone":66,"phoneExt":32,"email":67},"Eduardo Castillo Leon, MD","617-722-3874","eduardo.castilloleon@nationwidechildrens.org",[69],{"facility":5,"status":70,"city":71,"state":72,"zip":73,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":81,"contacts":82},"RECRUITING","Columbus","Ohio","43205","United States","US",{"type":77,"coordinates":78},"Point",[79,80],-82.99879,39.96118,{"lat":80,"lon":79},[83],{"name":57,"role":61,"phone":62,"phoneExt":32,"email":63},{"type":58,"investigatorFullName":85,"investigatorTitle":86,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Peter Lu","Professor of Pediatrics","100654203","transauricular-neurostimulation-for-abdominal-pain-due-to-dgbi-100654203",false,"NCT07798180","Transauricular Neurostimulation for Abdominal Pain Due to DGBI","Transauricular Neurostimulation for Irritable Bowel Syndrome","Inclusion Criteria:\n\n* Age 12-18 years.\n* Clinical diagnosis of an abdominal pain-related disorder of gut-brain interaction (DGBI) meeting Rome IV criteria.\n* Average abdominal pain intensity ≥3 on a 0-10 scale and pain on at least 2 days per week.\n* Proper fit of the Sparrow earpiece on the left ear, as determined by study personnel.\n\nExclusion Criteria:\n\n* Medical or psychiatric condition that contraindicates transauricular neurostimulation or creates a safety risk.\n* Abnormal ear anatomy preventing earpiece placement.\n* Developmental delay.\n* Implanted electronic device or hearing aid.\n* Participation in another interventional trial.\n* Pregnancy\n* Unable to communicate in English.\n* Prisoner.\n* Change in medications used to treat abdominal pain or gastrointestinal symptoms within 2 weeks before enrollment. Participants must be on stable doses for at least 2 weeks before enrollment.","ALL","12 Years","18 Years",{"count":98,"type":99},30,"ESTIMATED","INTERVENTIONAL",[34],"This single-site, open-label pilot study will evaluate transcutaneous auricular neurostimulation using the Sparrow Link device as a treatment for adolescents aged 12 to 18 years with abdominal pain related to disorders of gut-brain interaction. Up to 30 participants will be enrolled, with a goal of 20 completing the study. Participants will use the device for at least one hour daily for 4 weeks and complete questionnaires through week 8. The study will assess adherence, retention, safety, and preliminary changes in abdominal pain, bowel symptoms, quality of life, and anxiety.",[104,105],"Abdominal Pain (AP)","Disorders of Gut-brain Interaction",[107,108,109,110],"transcutaneous auricular neurostimulation","neuromodulation","pediatric abdominal pain","DGBI","2026-08-27",{"date":113,"type":114},"2026-09-01","ACTUAL",{"date":116,"type":114},"2025-10-23",{"date":118,"type":99},"2026-10-30",{"name":5,"class":6},1]