[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625112":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":36,"centralContacts":41,"locations":52,"responsibleParty":95,"collaborators":27,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":27,"eligibilityCriteria":103,"healthyVolunteers":99,"sex":104,"minAge":105,"maxAge":106,"enrollmentInfo":107,"targetDuration":27,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":121,"whyStopped":27,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},{"fullName":5,"class":6},"VA Office of Research and Development","FED",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Exoskeleton-Assisted Walking (EAW) + active Transcutaneous Spinal Cord Stimulation (tSCS)","EXPERIMENTAL","The EAW + active tSCS group will receive simultaneous lumbosacral tSCS while simultaneously performing EAW.",[13,14],"Device: Exoskeleton-Assisted Walking (EAW)","Device: Active Transcutaneous Spinal Cord Stimulation (tSCS)",{"label":16,"type":17,"description":18,"interventionNames":19},"Exoskeleton-assisted walking (EAW) + sham Transcutaneous Spinal Cord Stimulation (tSCS)","SHAM_COMPARATOR","The EAW + sham tSCS group will receive simultaneous lumbosacral sham tSCS while simultaneously performing EAW. Participants in both groups will receive 60 minutes of EAW + sham tSCS overground training per session for a total of 108 sessions (3 X week for 36 weeks).",[13,20],"Device: Sham Transcutaneous Spinal Cord Stimulation (tSCS)",[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DEVICE","Exoskeleton-Assisted Walking (EAW)","Participants will perform EAW will for 60 minutes per session for a total of 108 sessions (3 X week for 36 weeks).",[9,16],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Sham Transcutaneous Spinal Cord Stimulation (tSCS)","The lumbosacral tSCS electrical signal is set too low to have any biological effect while simultaneously performing EAW.",[16],{"type":23,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"Active Transcutaneous Spinal Cord Stimulation (tSCS)","Participants in the active tSCS group will receive simultaneous lumbosacral tSCS while simultaneously performing EAW.",[9],[37],{"name":38,"affiliation":39,"role":40},"Chris Cirnigliaro, MS","James J. Peters Veterans Affairs Medical Center","PRINCIPAL_INVESTIGATOR",[42,47],{"name":38,"role":43,"phone":44,"phoneExt":45,"email":46},"CONTACT","(973) 731-3900","2755","christopher.cirnigliaro@va.gov",{"name":48,"role":43,"phone":49,"phoneExt":50,"email":51},"Christopher Cardozo, MD","(718) 584-9000","1828","Christopher.Cardozo@va.gov",[53,75],{"facility":54,"status":27,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Kessler Foundation","West Orange","New Jersey","07052","United States","US",{"type":61,"coordinates":62},"Point",[63,64],-74.23904,40.79871,{"lat":64,"lon":63},[67,71],{"name":68,"role":43,"phone":69,"phoneExt":27,"email":70},"Gail F Forrest, PhD","973-731-3900","gforrest@kesslerfoundation.org",{"name":72,"role":43,"phone":73,"phoneExt":27,"email":74},"Steven C Kirshblum, MD","9737313900","skirshblum@kessler-rehab.com",{"facility":76,"status":27,"city":77,"state":78,"zip":79,"country":58,"countryCode":59,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"James J. Peters VA Medical Center, Bronx, NY","The Bronx","New York","10468-3904",{"type":61,"coordinates":81},[82,83],-73.86641,40.84985,{"lat":83,"lon":82},[86,90,94],{"name":87,"role":43,"phone":49,"phoneExt":88,"email":89},"Robert Jordan","6020","robert.jordan@va.gov",{"name":91,"role":43,"phone":49,"phoneExt":92,"email":93},"Juan C Bandres, MD","6667","juan.bandres2@va.gov",{"name":38,"role":40,"phone":27,"phoneExt":27,"email":27},{"type":96,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100625112","exoskeletal-assisted-walking-combined-with-transcutaneous-spinal-cord-stimulation-effect-on-imaging-and-serum-biomarkers-of-skeletal-muscle-mass-and-bone-strength-100625112",false,"NCT07418398","Exoskeletal-assisted Walking Combined With Transcutaneous Spinal Cord Stimulation: Effect on Imaging and Serum Biomarkers of Skeletal Muscle Mass and Bone Strength.","Exoskeletal-assisted Walking Combined With Transcutaneous Spinal Cord Stimulation: Effect on Imaging and Serum Biomarkers of Skeletal Muscle Mass and Bone Strength","Inclusion Criteria:\n\n* Non-walkers with an SCI greater than 3 years post injury\n* As measured by a member of the study staff, participants who have a lower extremity motor score greater or equal to 16 on the INSCSCI exam with an impairment grade of C or D\n* Neurologic level of injury as determined by study staff between C5-T10 (completed at participant's screening)\n* Capable of gripping Lofstrand crutches and\u002For a walker without assistance\n* Wheelchair reliant 100% of the time\n* Height is between 62 inches and 74 inches\n* Weight less than 220lbs\n* Anthropometric compatibility with the EAW device:\n\n  * Thigh length between 14 and 19 in (36 and 48 cm)\n  * Shank length between 17 and 22 in (43 and 55 cm)\n\nExclusion Criteria:\n\n* As determined by the study physician from the screening health exam, a history of fragility or traumatic fractures, unhealed fractures, and signs of swelling, bruising, and discoloration of the legs\n* Current bone disease diagnosis (e.g., osteomyelitis, hyperparathyroidism)\n* As determined by the study physician from the screening DXA study, a T-score at the total hip \\\u003C -3.5 or aBMD of the knee (proximal tibia and\u002For distal femur) \\\u003C 0.60 g\u002Fcm2 from the DXA screen\n* Positive pregnancy test at any of the study intervention or assessment visits, or if female participants plan to become pregnant over the course of the study, they will be excluded or withdrawn (if already enrolled) from participation\n* Currently in a gym\u002Frehabilitation program performing ambulatory interventions such as EAW, as determined by the study staff\n* Currently prescribed any medications that can affect muscle and\u002For bone metabolism, as determined by the study staff\n\nExclusion Criteria from MRI Safety Screening:\n\n* Medically unsafe to receive an MRI scan\n* Claustrophobia\n* Baclofen pump\n* Body metal, including any of the following:\n\n  * metal fragments or pieces in eyes or any other part of body\n  * pacemakers or other implanted electrical devices\n  * aneurysm clips (metal clips on wall of a large artery)\n  * metallic prostheses (metal pins and heart valves)\n  * internal hearing aids (cochlear implants)\n  * permanent eyeliner\n  * shrapnel fragments\n  * piercing that cannot be removed","ALL","21 Years","60 Years",{"count":108,"type":109},24,"ESTIMATED","INTERVENTIONAL",[112],"NA","Immobilization following spinal cord injury (SCI) results in muscle and bone loss below the level of injury, which ultimately predisposes to fracture at several sites throughout the legs and can lead to several medical complications that can devastate quality of life. There is a scarcity of research that has successfully implemented rehabilitation and\u002For exercise training interventions to preserve the musculoskeletal system during the acute phase SCI, or possibly reverse the muscle and bone loss that has already occurred in chronic SCI. This study will compare the effect of exoskeleton-assisted walking (EAW) training combined with transcutaneous spinal cord stimulation (tSCS) (EAW + active tSCS), to that of EAW + sham tSCS, on measures of muscle and bone health in a cohort of chronically injured motor incomplete SCI. A successful outcome would expand treatment options to improve musculoskeletal health over the lifetime.",[115],"Spinal Cord Injury",[115,117,118,119,120],"Transcutaneous Spinal Cord Stimulation","Bone Mineral Density","Exoskeleton-Assisted Walking","Muscle Cross Sectional Area","NOT_YET_RECRUITING","2026-07-20",{"date":124,"type":125},"2026-07-22","ACTUAL",{"date":127,"type":109},"2026-11-01",{"date":129,"type":109},"2032-11-01",{"name":5,"class":6},2]