[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100580395":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":31,"locations":41,"responsibleParty":59,"collaborators":62,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":25,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":25,"enrollmentInfo":75,"targetDuration":25,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":44,"whyStopped":25,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"MetroHealth Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Target genital nerve stimulation","EXPERIMENTAL","Stimulation waveforms consist of biphasic, charge-balanced square pulses with a pulse width of 0.2 ms and delivered at 20 Hz. Stimuli will be applied over a range of amplitudes to determine the threshold of stimulation for producing reflex contraction of the anal sphincter (the pudendo-anal reflex). Subsequent stimulation will be applied at threshold for the first week, at 1.5 threshold for the second week, and at twice threshold (or max tolerance) for the third and fourth weeks. The typical stimulation range is 20-40 milliamps (mA) and has been shown to be well tolerated by individuals with sensation. Stimulation will be applied continuously for 6-8 hours daily for four weeks.",[13],"Device: Genital nerve stimulation",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham genital nerve stimulation","SHAM_COMPARATOR","Sham stimulation will be applied in the same manner as target stimulation, except that the stimulation frequency will be 1 Hz and the stimulation amplitude will be set to a limit that is at the threshold of perception if individuals have sensation, or 10 mA if they do not have sensation. Stimulation will be applied continuously for 6-8 hours daily for four weeks.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Genital nerve stimulation","Genital nerve stimulation (GNS) will be administered via non-invasive surface skin electrodes. In men, two surface electrodes (1 cm diameter) will be placed on the dorsum of the penile shaft 2 cm apart. In women, one surface electrode will be placed near the clitoris and a second surface electrode will be placed on the labia majora or inner thigh. The electrodes will be connected to an electrical stimulator device.",[15,9],null,[27],{"name":28,"affiliation":29,"role":30},"Kim Anderson, PhD","MetroHealth System, Ohio","PRINCIPAL_INVESTIGATOR",[32,37],{"name":33,"role":34,"phone":35,"phoneExt":25,"email":36},"Mayson Moore","CONTACT","216-957-3518","mmoore12@metrohealth.org",{"name":38,"role":34,"phone":39,"phoneExt":25,"email":40},"Megan Hammond Nechols","216-957-3562","mhammond1@metrohealth.org",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"MetroHealth Center for Rehabilitation Research","RECRUITING","Cleveland","Ohio","44109","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-81.69541,41.4995,{"lat":54,"lon":53},[57,58],{"name":33,"role":34,"phone":35,"phoneExt":25,"email":36},{"name":38,"role":34,"phone":39,"phoneExt":25,"email":40},{"type":30,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Kimberly Anderson, PhD","Professor",[63],{"name":64,"class":65},"Congressionally Directed Medical Research Programs","FED","100580395","at-home-genital-nerve-stimulation-for-sci-bowel-100580395",false,"NCT06836739","At-Home Genital Nerve Stimulation for SCI Bowel","At-Home Feasibility Trial of Genital Nerve Stimulation to Modulate Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury","Inclusion Criteria:\n\n1. Traumatic SCI.\n2. Minimum of 6 months' post-injury.\n3. Aged 18 years and older.\n4. Neurological level of injury T12 or higher and AIS grade A-D, as defined by the ISNCSCI.\n5. Score of 14 or higher on the ISCI BF BDS v2.1.\n6. Response to genital nerve stimulation able to be elicited upon screening.\n7. Able to understand and provide informed consent.\n\nExclusion Criteria:\n\n1. Currently enrolled in another functional electrical stimulation (FES) research trial.\n2. Females who are pregnant or planning to become pregnant in the duration of the trial (identified by self-report).\n3. Presence of a cardiac pacemaker, implanted defibrillator, or other implanted functional electrical stimulation device if, upon clinical evaluation, it may have an interaction with GNS.\n4. In the judgment of the PI and Co-Investigators, presence of medical complications that may interfere with the execution of the study.","ALL","18 Years",{"count":76,"type":77},12,"ESTIMATED","INTERVENTIONAL",[80],"NA","The purpose of this study is to test whether electrical stimulation of the skin in the pelvic area (near the genitals) can reduce the reflexes that cause bowel accidents in people with spinal cord injuries. Current bowel treatments either involve diet and medications or surgery. This study will evaluate whether electrical stimulation can be an alternate option for bowel management.\n\nResearchers will:\n\n* Use an FDA approved Transcutaneous Electrical Nerve Stimulation (TENS) device off-label\n* Compare a target stimulation level to a placebo stimulation level\n\nParticipants will:\n\n* Use electrical stimulation on the skin in the pelvic area for 6-8 hours each day for 4 weeks at home\n* Visit the research center 3 times to participate in exams and answer questions\n* Keep a daily diary of their bowel symptoms and stimulation times",[83],"Spinal Cord Injury",[85,86,87,88,89,90,91,92,93,94],"fecal incontinence","neurogenic bowel","tetraplegia","paraplegia","paralysis","electrical stimulation","neuromodulation","bowel","feasibility","anorectal manometry","2025-11-24",{"date":97,"type":98},"2025-12-02","ACTUAL",{"date":100,"type":98},"2025-03-01",{"date":102,"type":77},"2026-09-30",{"name":5,"class":6},1]