[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100459848":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":39,"locations":45,"responsibleParty":68,"collaborators":71,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":25,"eligibilityCriteria":80,"healthyVolunteers":77,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":25,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":25,"overallStatus":47,"whyStopped":25,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"University of Washington","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Open-loop Stimulation","EXPERIMENTAL","Continuous stimulation",[13,14],"Device: Open-loop Stimulation","Other: Functional Task Practice",{"label":16,"type":10,"description":17,"interventionNames":18},"Close-loop Stimulation","Intended movement-based stimulation.",[19,14],"Device: Close-loop Stimulation",[21,26,29],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Spinal cord stimulation will be applied continuously over the skin throughout the intervention session.",[9],null,{"type":22,"name":16,"description":27,"armGroupLabels":28,"otherNames":25},"Spinal cord stimulation will start and stop based on the signals that come from the sensors placed on upper limb muscle surfaces.",[16],{"type":6,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Functional Task Practice","Exercise therapy consists of repeated functional hand and arm movements",[16,9],[34],"Intensive exercise therapy",[36],{"name":37,"affiliation":5,"role":38},"Chet Moritz, Ph.D.","PRINCIPAL_INVESTIGATOR",[40],{"name":41,"role":42,"phone":43,"phoneExt":25,"email":44},"Fatma Inanici, MD., Ph.D.","CONTACT","206 787 2692","finanici@uw.edu",[46],{"facility":5,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"RECRUITING","Seattle","Washington","98195","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-122.33207,47.60621,{"lat":57,"lon":56},[60,63,65],{"name":61,"role":42,"phone":62,"phoneExt":25,"email":44},"Fatma Inanici, MD, Ph.D.","206-787-2692",{"name":64,"role":38,"phone":25,"phoneExt":25,"email":25},"Chet T. Moritz, PhD",{"name":66,"role":67,"phone":25,"phoneExt":25,"email":25},"Fatma Inanici, MD, PhD","SUB_INVESTIGATOR",{"type":38,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Chet Moritz","Professor",[72],{"name":73,"class":74},"Congressionally Directed Medical Research Programs","FED","100459848","closed-loop-spinal-stimulation-for-restoration-of-upper-extremity-function-after-spinal-cord-injury-100459848",false,"NCT05267951","Closed-loop Spinal Stimulation for Restoration of Upper Extremity Function After Spinal Cord Injury","Inclusion Criteria:\n\n1. has cervical (C8 or higher), incomplete (American Spinal Cord Injury Impairment Scale - C or D) traumatic spinal cord injury, minimum 1-year post-injury\n2. has difficulty with hand functions in activities of daily living (e.g., dressing, grooming, feeding)\n3. stable medical condition without cardiopulmonary disease or autonomic dysreflexia that would contraindicate participation in upper extremity rehabilitation or testing activities\n4. capable of performing simple cued motor tasks\n5. has ability to attend intervention\u002Ffunctional task training and assessment sessions 3 times\u002Fweek\n6. has adequate social support to participate in all intervention and baseline\u002Ffollow-up assessment sessions throughout 40 weeks.\n7. has ability to read and speak English\n\nExclusion Criteria:\n\n1. dependent on ventilation support\n2. has implanted stimulator (e.g., pacemaker, vagus nerve stimulator, cochlear implant, etc.) or baclofen pump\n3. has metallic devices and implants in the head (e.g., deep brain stimulators, aneurysm clips\u002Fcoils, and stents, vagus nerve stimulators)\n4. has a history or current signs\u002Fsymptoms of syringomyelia (progressive pain, muscle weakness, and\u002For sensory loss; deterioration of bowel\u002Fbladder function)\n5. has autoimmune etiology of spinal cord dysfunction\u002Finjury\n6. has received botulinum toxin injections in upper extremity muscles in the prior 6 months\n7. has tendon transfer or nerve transfer surgery in the upper extremity,\n8. taking tizanidine, dantrolene or diazepam\n9. has history of seizures or increased risk for seizures\n10. has history of chronic headaches or migraines\n11. has history of neurologic diseases, such as stroke, multiple sclerosis, traumatic brain injury, etc.\n12. has peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.)\n13. has rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.)\n14. has significant medical disease; including uncontrolled systemic hypertension with values above 170\u002F100 mmHg; cardiac or pulmonary disease; uncorrected coagulation abnormalities or need for therapeutic anticoagulation\n15. has cardiovascular or musculoskeletal disease or injury that would prevent full participation in physical therapy intervention\n16. unhealed fracture, contracture, pressure sore, or frequent urinary tract infections or other illnesses that might interfere with upper extremity rehabilitation or testing activities\n17. has a history of severe allergy (i.e., allergic reaction that could not be treated with antihistaminic medication\n18. has alcohol and\u002For drug abuse (subject's verbal statement)\n19. has cancer\n20. pregnant (Childbearing potential will be asked at screening, baseline, and every subsequent visit in which the subject would receive transcutaneous spinal cord stimulation and\u002For Transcranial Magnetic Stimulation whether the participant could be pregnant. Pregnancy will be ruled out by an over-the-counter urine pregnancy test for all females of childbearing potential (1) at the time of enrollment, (2) prior to all sessions that include Transcranial Magnetic Stimulation, and also prior to the intervention phases of (3) closed-loop or (4) open-loop stimulation. Additional pregnancy tests may be performed if there is a concern of pregnancy.)\n21. lack of ability to fully comprehend, cooperate and\u002For safely perform study procedures in the investigator's opinion\u002Fjudgment\n22. unable to read and\u002For comprehend the consent form","ALL","21 Years","70 Years",{"count":85,"type":86},9,"ESTIMATED","INTERVENTIONAL",[89],"NA","The purpose of this study is to assess the efficacy of non-invasive (transcutaneous) closed-loop electrical spinal cord stimulation for recovery of upper limb function (Aim 1) and spasticity (Aim 2) following spinal cord injury.",[92],"Spinal Cord Injuries","2026-08-14",{"date":95,"type":96},"2026-08-18","ACTUAL",{"date":98,"type":96},"2022-10-12",{"date":100,"type":86},"2028-06-30",{"name":5,"class":6},1]