[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100169050":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":38,"responsibleParty":56,"collaborators":55,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":55,"enrollmentInfo":67,"targetDuration":55,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":79,"overallStatus":40,"whyStopped":55,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"VA Office of Research and Development","FED",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Neuroprosthesis","EXPERIMENTAL","Volunteers are evaluated for appropriateness for inclusion in the study on an intent-to-treat basis. Qualifying candidates all receive the implanted neuroprosthesis and participate in post-operative training and follow-up procedures.",[13],"Device: IRS-8 (8-Channel implanted stimulator-telemeter)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","IRS-8 (8-Channel implanted stimulator-telemeter)","Surgical implantation of the 8-channel neuroprosthesis",[9],[21],"Implanted Neuroprosthesis for Seated Posture and Balance, Trunk implanted electrical stimulation system, Implanted trunk control neuroprosthesis, Implanted FNS",[23],{"name":24,"affiliation":25,"role":26},"Ronald Triolo, PhD","Louis Stokes VA Medical Center, Cleveland, OH","PRINCIPAL_INVESTIGATOR",[28,34],{"name":29,"role":30,"phone":31,"phoneExt":32,"email":33},"Lisa M Lombardo, MPT","CONTACT","(216) 791-3800","4909","Lisa.Lombardo2@va.gov",{"name":35,"role":30,"phone":31,"phoneExt":36,"email":37},"Emily C Johnson, BA","64904","emily.johnson17@va.gov",[39],{"facility":25,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","Cleveland","Ohio","44106-1702","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-81.69541,41.4995,{"lat":50,"lon":49},[53,54],{"name":29,"role":30,"phone":31,"phoneExt":32,"email":33},{"name":24,"role":26,"phone":55,"phoneExt":55,"email":55},null,{"type":57,"investigatorFullName":55,"investigatorTitle":55,"investigatorAffiliation":55,"oldNameTitle":55,"oldOrganization":55},"SPONSOR","100169050","a-neuroprosthesis-for-seated-posture-and-balance-100169050",false,"NCT01474148","A Neuroprosthesis for Seated Posture and Balance","Trunk Protocol","Inclusion Criteria:\n\n* C4-T12\n* ASIA Scale A through C\n* Time post injury greater than 6 months\n* Innervated and excitable trunk and pelvis musculature\n* Absence of acute or chronic psychological problems or chemical dependency\n* Range of motion within normal limits\n* Controlled spasticity and absence of hip flexion and adduction spasm\n* Height and weight within normal limits\n* No history of balance problems or spontaneous falls\n* No history of spontaneous fracture or evidence low bone density\n* No acute orthopaedic problems\n* No acute medical complications\n* Adequate social support and stability\n* Able to speak and read English\n\nExclusion Criteria:\n\n* Pregnancy\n* Non-English speaking","ALL","21 Years",{"count":68,"type":69},10,"ESTIMATED","INTERVENTIONAL",[72],"NA","The purpose of this study is to evaluate a surgically implanted functional electrical stimulation (FES) system to facilitate stability of the trunk and hips. FES involves applying small electric currents to the nerves, which cause the muscles to contract. This study evaluates how stabilizing and stiffening the trunk with FES can change the way spinal cord injured volunteers sit, breathe, reach, push a wheelchair, or roll in bed.",[75,76,77,78],"Spinal Cord Injury","Paralysis","Tetraplegia","Paraplegia",[80,81,82,83],"paraplegia","tetraplegia","Spinal cord injured","FES","2025-10-23",{"date":86,"type":87},"2025-10-27","ACTUAL",{"date":89,"type":87},"2011-11-30",{"date":91,"type":69},"2027-01-31",{"name":5,"class":6},1]