[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590262":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":37,"responsibleParty":57,"collaborators":60,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":20,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":20,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":40,"whyStopped":20,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Louis Stokes VA Medical Center","FED",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Implantation, controller development and evaluation","EXPERIMENTAL","This phase includes installing the device and setting the individual up for use of the system and evaluating the effect of the system on walking ability.",[13],"Device: NNP-LE",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","NNP-LE","Networked NeuroProsthesis - Lower Extremity Configuration (NNP-LE) measuring physiologic command signals and delivering neural stimulation to intramuscular and nerve cuff electrodes for trunk and leg muscle assistance.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Nathan Makowski, PhD","MetroHealth System, Ohio","PRINCIPAL_INVESTIGATOR",[27,33],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},"Lisa Lombardo, MPT","CONTACT","216-791-3800","64909","lisa.lombardo2@va.gov",{"name":34,"role":29,"phone":30,"phoneExt":35,"email":36},"Maura Malenchek, PTA","64989","maura.malenchek@va.gov",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Louis Stokes Cleveland Veterans Affairs Medical Center","RECRUITING","Cleveland","Ohio","44106","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-81.69541,41.4995,{"lat":50,"lon":49},[53,55,56],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":54},"lisalombardo2@va.gov",{"name":34,"role":29,"phone":30,"phoneExt":35,"email":36},{"name":23,"role":25,"phone":20,"phoneExt":20,"email":20},{"type":25,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Nathan Makowski","Associate Professor",[61,64],{"name":62,"class":63},"MetroHealth Medical Center","OTHER",{"name":65,"class":66},"CDMRP","UNKNOWN","100590262","implant-for-walking-after-incomplete-sci-100590262",false,"NCT06965127","Implant for Walking After Incomplete SCI","Enhancing Walking and Independence After Incomplete SCI With a Fully Implanted Neuroprosthesis","Inclusion Criteria:\n\n* Between the ages of 18-75\n* Non-ventilator dependent paralysis resulting from injuries such as: cervical\u002Fthoracic spinal cord injuries affecting the trunk and\u002For lower limbs\n* Impairment classification of AIS B, C, or D (preservation of sensation and\u002For some motor function) with weakness in trunk and\u002For lower extremity muscles\n* Unable to walk faster than 0.8m\u002Fs during a 10m walk test\n* Gait deviation such as reduced peak hip, knee, and\u002For ankle range of motion during stance or swing phases due to motor impairment\n* Time post injury greater than six months\n* Innervated and excitable lower extremity and trunk musculature\n* Adequate social support and stability\n* Willingness to comply with follow-up procedures\n* Appropriate body habitus (height and weight within acceptable limits as determined by study physician)\n* Neurologically stable as determined by a physician\n\nExclusion Criteria:\n\n* Significant fracture risk or history of spontaneous fractures\n* History of heterotopic ossification at the hip, knee, or ankle\n* Non-English speaking\n* Insufficient upper extremity function to use an assistive device (e.g. walker or cane)\n* Females who are pregnant\n* Current pressure injury that would be exacerbated by study activities\n* Uncontrolled spasticity that would interfere with study activities\n* Significant range of motion limitations that would compromise study activities\n* History of vestibular dysfunction, balance problems, or spontaneous falls\n* Disorder or condition that require MRI monitoring\n* Acute and\u002For untreated orthopedic issues that would prevent weight bearing or exercising implanted muscles such as a dislocation or fracture\n* Acute and\u002For chronic medical problems left untreated or not controlled that would increase risk by using stimulation such as cardiac abnormalities, immunological\u002Fpulmonary\u002Frenal\u002Fcirculatory compromise\n* Uncontrolled diabetes or hypertension\n* Presence of a demand pacemaker, cardiac defibrillator, or neuroprosthesis system with components in the legs\n* Any other medical or psychological condition that would be a contraindication\n\nImplant eligibility criteria\n\n• In addition to all of the above, the participant must be able to fully support their body weight in standing with an assistive device prior to implantation.","ALL","18 Years","75 Years",{"count":78,"type":79},5,"ESTIMATED","INTERVENTIONAL",[82],"NA","This is a device study that will evaluate the effect of an implanted stimulator on improving walking in people with incomplete spinal cord injury. There are two phases in the study: 1) Screening - this phase determines if the individual is a good candidate to receive an implanted system, 2) Implantation, controller development, and evaluation - this phase includes implanting the device and setting the individual up for system use, creating controllers for walking, and evaluating the effect of the device over a couple years.",[85,86],"Spinal Cord Injury (SCI)","Gait",[88,89],"neuroprosthesis","implanted device","2025-11-20",{"date":92,"type":93},"2025-11-26","ACTUAL",{"date":95,"type":93},"2025-08-27",{"date":97,"type":79},"2031-08",{"name":5,"class":6},1]