[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100569744":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":46,"responsibleParty":65,"collaborators":26,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":26,"eligibilityCriteria":73,"healthyVolunteers":74,"sex":75,"minAge":76,"maxAge":26,"enrollmentInfo":77,"targetDuration":26,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":88,"overallStatus":94,"whyStopped":26,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Kessler Foundation","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"scTS","ACTIVE_COMPARATOR","This arm will receive 20 sessions of spinal cord transcutaneous stimulation (scTS) combined with physical therapy.",[13],"Device: Spinal cord transcutaneous stimulation",{"label":15,"type":16,"description":17,"interventionNames":18},"scTS+PNS","EXPERIMENTAL","This arm will receive 20 sessions of paired application of spinal cord transcutaneous stimulation (scTS) and peripheral nerve stimulation (PNS) followed by scTS combined with physical therapy.",[19],"Device: Paired spinal cord and peripheral nerve stimulation",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Spinal cord transcutaneous stimulation","Physical therapy combined with spinal cord transcutaneous stimulation will increase activity in the paralyzed or weak arm and hand muscles in individuals with spinal cord injury. Transcutaneous spinal cord stimulation is a non-invasive stimulation strategy and are known to facilitate recovery of lost function post spinal cord injury.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Paired spinal cord and peripheral nerve stimulation","Physical therapy combined with paired spinal cord-peripheral nerve stimulation will increase activity in the paralyzed or weak arm and hand muscles in individuals with spinal cord injury. Transcutaneous spinal cord and peripheral nerve stimulation are both non-invasive stimulation strategy and are known to facilitate recovery of lost function post spinal cord injury.",[15],[23,32],"Peripheral nerve stimulation",[34],{"name":35,"affiliation":5,"role":36},"Gail Forrest, Ph.D.","PRINCIPAL_INVESTIGATOR",[38,43],{"name":39,"role":40,"phone":41,"phoneExt":26,"email":42},"LeighAnn Martinez","CONTACT","973-324-3557","lmartinez@kesslerfoundation.org",{"name":44,"role":40,"phone":41,"phoneExt":26,"email":45},"Pawan Sharma, Ph.D.","psharma@kesslerfoundation.org",[47],{"facility":5,"status":26,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"West Orange","New Jersey","07052","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-74.23904,40.79871,{"lat":57,"lon":56},[60,61,63],{"name":35,"role":40,"phone":26,"phoneExt":26,"email":26},{"name":62,"role":40,"phone":26,"phoneExt":26,"email":26},"Susan Harkema, Ph.D.",{"name":64,"role":40,"phone":26,"phoneExt":26,"email":26},"Pawan Sharma, PT. Ph.D.",{"type":36,"investigatorFullName":64,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Postdoctoral Fellow","100569744","paired-spinal-cord-and-peripheral-nerve-stimulation-to-recover-hand-function-in-sci-100569744",false,"NCT06698224","Paired Spinal Cord and Peripheral Nerve Stimulation to Recover Hand Function in SCI","Paired Spinal Cord and Peripheral Nerve Stimulation for Hand Function Recovery in Humans Post Cervical SCI","For SCI participants:\n\nInclusion Criteria:\n\n* At least 18 years of age\n* Non-progressive cervical SCI\n* Greater than or equal to 6-months post spinal cord injury\n* Stable medical condition\n* Viable median and ulnar nerve as evident from MMR and M-Wave recordings\n* Wrist extensor and finger flexors score between 1-3 for both upper extremity for ISNCSCI motor assessment.\n\nExclusion Criteria:\n\n* Ventilator Dependent\n* Untreated fracture or pressure ulcer\n* Untreated psychiatric disorder or ongoing drug abuse\n* Cardiac, respiratory, bladder, renal, or other untreated medical disorder unrelated to SCI\n* Skeletal muscle Botox injections less than 6 months prior\n* Previous tendon transfer of the arm or arms\n* Any implanted pump (i.e., baclofen pump, pain pump, etc.) prior to randomization\n* Pregnant at the time of enrollment or planning to become pregnant during the course of the study\n* Unable or unwilling to wean from anti-spasticity medications\n* History of seizure or epilepsy\n* Metal in Head\n* Cochlear implant\n* Implanted brain stimulators\n* Aneurysm clips\n* Increased intracranial pressure (which lowers seizure threshold)\n* Cardiac pacemaker\n* Personal or family history of epilepsy\n* Tricyclic antidepressants or neuroleptics (which lower seizure threshold)\n\nFor healthy volunteer\u002Fparticipants:\n\nInclusion Criteria:\n\n* At least 18 years of age\n\nExclusion Criteria:\n\n* Neurological injury or disease\n* Pregnant at the time of enrollment or planning to become pregnant during the course of the study\n* Personal or family history of seizure or epilepsy\n* Tricyclic antidepressants or neuroleptics (which lower seizure threshold)",true,"ALL","18 Years",{"count":78,"type":79},14,"ESTIMATED","INTERVENTIONAL",[82],"NA","Individuals who suffer a spinal cord injury in the neck region have difficulty using their hands due to paralysis and\u002For weakness of their arms and hand muscles. This project aims to test the effects of pairing spinal cord and nerve stimulation combined with physical therapy training in recovering arms and hand function. The long-term goal is to provide better therapies that will improve the ability of individuals with spinal cord injuries to use their arms and hands to perform everyday tasks, similar to injury before.",[85,86,87],"Spinal Cord Injury","Spinal Cord Disease","Spinal Cord Injuries (SCI)",[89,90,91,92,93],"Spinal cord injury","Hand function","Spinal cord stimulation","Paired stimulation","Physical therapy","NOT_YET_RECRUITING","2024-11-18",{"date":97,"type":98},"2024-11-20","ACTUAL",{"date":100,"type":79},"2025-01-02",{"date":102,"type":79},"2026-11-01",{"name":5,"class":6},1]