[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100317169":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":36,"responsibleParty":53,"collaborators":56,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":66,"acronym":20,"eligibilityCriteria":67,"healthyVolunteers":64,"sex":68,"minAge":69,"maxAge":20,"enrollmentInfo":70,"targetDuration":20,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":38,"whyStopped":20,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Louis Stokes VA Medical Center","FED",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Stimulating nerve electrodes & intramuscular recording electrodes","EXPERIMENTAL","Fifteen subjects with lower limb amputation will have multi-contact stimulating nerve cuff electrodes implanted around the nerves in their residual limb. These electrodes will be connected to temporary percutaneous leads.\n\nDuring experimental testing, a small amount of electrical current will be delivered to the nerves through multi-contact nerve cuff electrodes.\n\nParticipants also have the option to have recording electrodes implanted within muscles in their lower limb(s). These muscles are associated with prosthetic movement, and recordings from these muscles will be used to develop a controller for a robotic myoelectric prosthesis.",[13],"Device: Stimulating nerve electrodes and intramuscular recording electrodes",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Stimulating nerve electrodes and intramuscular recording electrodes","See Arm Description",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Ronald Triolo, PhD","PRINCIPAL_INVESTIGATOR",[26,32],{"name":27,"role":28,"phone":29,"phoneExt":30,"email":31},"Aarika Sheehan, PT, DPT","CONTACT","216-791-3800","65832","Aarika.Sheehan@va.gov",{"name":33,"role":28,"phone":34,"phoneExt":20,"email":35},"jessica jarvela, MS","216-769-0531","jessica.jarvela@va.gov",[37],{"facility":5,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"RECRUITING","Cleveland","Ohio","44106","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-81.69541,41.4995,{"lat":48,"lon":47},[51,52],{"name":27,"role":28,"phone":29,"phoneExt":30,"email":31},{"name":23,"role":24,"phone":20,"phoneExt":20,"email":20},{"type":24,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Ronald Triolo","Senior Research Career Scientist, US Department of Veterans Affairs,",[57,60],{"name":58,"class":59},"Case Western Reserve University","OTHER",{"name":61,"class":6},"United States Department of Defense","100317169","feasibility-of-neural-feedback-for-lower-limb-amputees-100317169",false,"NCT03409133","Feasibility of Neural Feedback for Lower Limb Amputees","Inclusion Criteria:\n\n* Adults age 18 or greater\n* Chronic, medically stable ( \\> 3 months) trans-tibial or trans-femoral amputation at the time of implant surgery.\n* Potential user of trans-tibial or trans-femoral prostheses for standing or walking\n* Viable target nerves in the lower extremity as determined by standard-of-care clinical tests of nerve conduction, response to stimulation, sensory evoked potentials and the like\n* Good skin integrity and personal hygiene\n* Absence of autoimmune deficiencies, seizure disorders or cardiac abnormalities contraindicating stimulation\n* Sufficient social support and personal ability to tolerate study procedures and comply with follow-up schedule\n\nExclusion Criteria:\n\n* Uncontrolled diabetes to a degree that would preclude surgery\n* Significant vascular disease\n* Chronic skin ulcerations\n* Significant history of poor wound healing\n* Significant history of uncontrolled infections\n* Active infection\n* Significant pain in the residual or phantom limb\n* Pregnancy\n* Inability to speak English\n* Expectation that MRI will be required at any point for the duration of study or while percutaneous leads are in place\n* Severe neurological conditions that significantly impair balance or mobility to an extent that independent ambulation is impossible without assistance ( as determined by a healthcare provider)\n* Appropriate body habitus (height and weight within acceptable limits as determined by study physician)\n* Poor surgical candidate\n* Psychiatric or cognitive conditions that could affect cooperation or understanding of instructions and willingness to undergo psychological evaluation, if recommended by study surgeons or investigators.","ALL","18 Years",{"count":71,"type":72},15,"ESTIMATED","INTERVENTIONAL",[75],"NA","The purpose of this study is to evaluate the effectiveness of providing sensation of the missing limb to individuals with lower limb loss, including above and below knee amputees. The approach involves delivering small electrical currents directly to remaining nerves via implanted stimulating electrodes. These small electrical currents cause the nerves to generate signals that are then transferred to your brain similar to how information about the foot and lower limb used to be transferred to your brain prior to the amputation.\n\nIndividuals also have the option to have recording electrodes implanted within muscles of the lower limb(s) in an attempt to develop a motor controller that would enable the user to have intuitive control of a robotic prosthetic leg.",[78],"Amputation",[80,81,82,83,84,85,86,87,88,89,90,91,92,93,94],"prosthesis user","phantom sensation","sensory feedback","prosthesis","amputee","amputation","limb loss","robotic prosthesis","neuroprosthesis","sensory restoration","robotic","electromyography","EMG","sensation","myoelectric","2026-03-04",{"date":97,"type":98},"2026-03-06","ACTUAL",{"date":100,"type":98},"2015-11-05",{"date":102,"type":72},"2027-09-01",{"name":5,"class":6},1]