[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613306":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":35,"centralContacts":39,"locations":48,"responsibleParty":67,"collaborators":69,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":31,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":31,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":31,"overallStatus":51,"whyStopped":31,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"The University of Texas Health Science Center, Houston","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Bilateral iTNS","EXPERIMENTAL","participants will receive one active tibial nerve stimulation (TNS) device and both legs will receive active stimulation",[13],"Device: iTNS",{"label":15,"type":16,"description":17,"interventionNames":18},"Unilateral iTNS","ACTIVE_COMPARATOR","participants will receive one active and one sham tibial nerve stimulation (TNS) device. The treatment will only be delivered to the leg with the active device.",[13,19],"Device: Sham iTNS",{"label":21,"type":22,"description":23,"interventionNames":24},"Sham iTNS","SHAM_COMPARATOR","participants will receive one one sham tibial nerve stimulation (TNS) device for bilateral use.",[19],[26,32],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DEVICE","iTNS","The stimulation current will be gradually increased until bilateral toe flexion is achieved, then reduced to just below the motor contraction threshold. A 20 Hz frequency and 200 µs pulse width will be applied continuously for 30 minutes, five times a week.",[9,15],null,{"type":27,"name":21,"description":33,"armGroupLabels":34,"otherNames":31},"The sham devices are designed to mimic active stimulation by initially delivering electrical current sufficient to evoke toe flexion. However, once the current is reduced to the sensory stimulation threshold, the device automatically ramps down to 0mA while maintaining the appearance of normal functioning on the display screen.",[21,15],[36],{"name":37,"affiliation":5,"role":38},"Argyrios Stampas, MD","PRINCIPAL_INVESTIGATOR",[40,44],{"name":37,"role":41,"phone":42,"phoneExt":31,"email":43},"CONTACT","(713) 797-5938","argyrios.stampas@uth.tmc.edu",{"name":45,"role":41,"phone":46,"phoneExt":31,"email":47},"Danira Garcia Gutierrez","(713) 797-7133","Danira.GarciaGutierrez@uth.tmc.edu",[49],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"The University of Texas Health Science Center at Houston","RECRUITING","Houston","Texas","77030","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-95.36327,29.76328,{"lat":61,"lon":60},[64,66],{"name":37,"role":41,"phone":65,"phoneExt":31,"email":43},"713-797-5938",{"name":45,"role":41,"phone":46,"phoneExt":31,"email":47},{"type":38,"investigatorFullName":37,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Associate Professor",[70],{"name":71,"class":72},"Congressionally Directed Medical Research Programs","FED","100613306","home-neuromodulation-for-neurogenic-bladder-management-in-spinal-cord-injury-100613306",false,"NCT07264868","Home Neuromodulation for Neurogenic Bladder Management in Spinal Cord Injury","Home Neuromodulation for Neurogenic Bladder Management in Spinal Cord Injury: A Hybrid Implementation-Efficacy Trial","Inclusion Criteria:\n\n* Non-progressive chronic (\\>1 year) SCI\n* Neurologic level of injury T9 and above\n* Stable over active bladder (OAB) medications (≥3 months)\n* No contraindication to MRI (per MRI Safety Questionnaire)\n* English or Spanish speaking\n* Tolerate and be able to evoke toe flexion bilaterally with transcutaneous tibial nerve stimulation (tTNS) (self or assisted)\n* Pass the tTNS competency checklist to perform or direct performance of tTNS.\n\nExclusion Criteria:\n\n* Ongoing\u002Factive genitourinary oncologic diagnoses\n* History of other central nervous system disorder (CNS) disorders and\u002For peripheral neuropathy\n* Pregnancy or planning to become pregnant.\n* Lower Motor Neuron bladder\n* Restorative bladder surgery such as augmentation cystoplasty\n* Botulinum toxin-A injections in the bladder within 6 months of trial enrolment (injection in other sites is allowed)\n* Anticoagulation treatment or prophylaxis\n* Advanced peripheral vascular disease (gangrene, amputation, etc.)\n* History of intolerance to electrical stimulation, particularly of the leg","ALL","18 Years","75 Years",{"count":84,"type":85},21,"ESTIMATED","INTERVENTIONAL",[88],"NA","The purpose of this study is to determine the safety and efficacy of Injectrode Tibial Nerve Stimulation for bladder function in people with spinal cord injury.",[91,92],"Spinal Cord Injury (SCI)","Neurogenic Bladder (NB)","2026-05-07",{"date":95,"type":96},"2026-05-11","ACTUAL",{"date":93,"type":96},{"date":99,"type":85},"2028-09-01",{"name":5,"class":6},1]