[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07397559":3,"trial-entities:NCT07397559":94,"trial-summary:NCT07397559":98},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":46,"secondary_outcomes":51,"sex":58,"minimum_age":59,"maximum_age":60,"healthy_volunteers":15,"eligibility_criteria":61,"std_ages":65,"locations":69,"central_contacts":85,"overall_officials":91,"references":92,"see_also_links":93},"NCT07397559","202506064","Spatiotemporal tSCS in Spinal Cord Injury","Spatiotemporal Control of Transcutaneous Spinal Cord Stimulation for Motor Function in SCI","RECRUITING","2030-08-31","2026-02","2026-02-12","2026-01-19","Washington University School of Medicine","OTHER",false,"Spinal cord injury leads to long-lasting impairment, and currently, there is no cure for paralysis. Although transcutaneous spinal cord stimulation has shown promising results in recovering lost movements, its poor selectivity in muscle recruitment compared to invasive approaches limits the type of rehabilitation exercises that can be practiced. This project studies how spatial, frequency, and amplitude control of stimulation can be used to selectively target different neural pathways and muscle groups.","Spinal cord injury (SCI) is a life-altering event that leads to long-lasting motor impairment. Currently, there is no cure for paralysis. Transcutaneous spinal cord stimulation (tSCS) combined with exercise training can restore posture control, voluntary walking, and arm\u002Fhand function in people with SCI. However, its low selectivity in activating specific muscles compared to invasive approaches limits the rehabilitation exercises that can be practiced and help with recovery. This project will generate evidence-based knowledge of the neural mechanisms underlying spatial, frequency, and amplitude control of tSCS in generating different types of leg movements. Participants with SCI will perform leg movements using different stimulation parameter configurations in non-invasive tSCS. We will quantify changes in muscle recruitment, torque generation, and pain enabled by the different stimulation parameters. A clear understanding of the mechanisms by which these different parameters in non-invasive tSCS can be used to selectively target different muscle groups will promote the development of personalized therapies that directly target only those muscles that need assistance while respecting individuals' residual motor function.",[19],"Spinal Cord Injuries (SCI)",[21,22,23],"spinal cord injury","transcutaneous spinal cord stimulation","rehabilitation","INTERVENTIONAL","BASIC_SCIENCE",[27],"NA",{"count":29,"type":30},48,"ESTIMATED",[32,37,42],{"type":14,"name":33,"description":34,"armGroupLabels":35},"No Stimulation","Participants complete motor tasks and outcome assessments with no spinal cord stimulation applied.",[36],"No stimulation",{"type":38,"name":39,"description":40,"armGroupLabels":41},"DEVICE","Conventional tSCS","Non-invasive transcutaneous spinal cord stimulation (tSCS) is delivered at 30 Hz using a single cathode electrode targeting the lumbar spinal cord to reinforce leg motor output during study tasks",[39],{"type":38,"name":43,"description":44,"armGroupLabels":45},"Spatiotemporal tSCS","Stimulation parameters, including electrode location, stimulation frequency, and stimulation amplitude, are systematically varied to reinforce leg motor output during study tasks",[43],[47],{"measure":48,"description":49,"timeFrame":50},"Changes in Torque","The primary outcome is a measure of changes in voluntary torque production (Nm)","30 minutes",[52,55],{"measure":53,"description":54,"timeFrame":50},"Muscle activation","Muscle activation will be measured through electromyography as the peak-to-peak of the evoked responses (mV)",{"measure":56,"description":57,"timeFrame":50},"Pain\u002FNociception","Pain will be evaluated using the Nociception Level (NOL) index during the different stimulation conditions. (Range: 0-100, 0 = no detectable nociceptive response, 100 = extreme nociceptive response)","ALL","16 Years","65 Years",{"inclusion":62,"exclusion":63,"raw_text":64},[],[],"Inclusion Criteria:\n\n1. Age between 16 and 65 years.\n2. Have a spinal cord injury (neurological level C3-T12) that occurred ≥1 year (chronic stage) prior to enrollment.\n3. American Spinal Injury Association (ASIA) Impairment Scale (AIS) classification C or D\n4. Able to voluntarily contract (motor score ≥ 1) at least two leg muscles (visual or palpable contraction).\n5. Use of prescription medication(s) for control of spasticity has not changed in the last 2 weeks\n6. Able to provide consent\n7. Ability to follow multiple instructions and communicate pain or discomfort\n\nExclusion Criteria:\n\n1. Progressive spinal lesions, including degenerative disorders of the spinal cord\n2. Pregnant, planning to become pregnant, or currently breastfeeding\n3. History of cardiopulmonary disease or cardiac symptoms\n4. Implanted stimulators of any type (baclofen pump, epidural spinal stimulator, cardiac defibrillator, pace-maker, etc.)\n5. Presence of orthopedic conditions that would negatively affect participation in leg exercise\n6. History of autonomic dysreflexia that is severe, unstable, and\u002For uncontrolled\n7. Unstable or significant medical conditions that can interfere with exercise or neurophysiological evaluations, such as severe neuropathic pain, depression, mood disorders, or other cognitive disorders\n8. Spasms that limit the ability to participate in leg exercise activity\n9. Breakdown in skin area that will be in contact with electrodes",[66,67,68],"CHILD","ADULT","OLDER_ADULT",[70],{"facility":71,"status":8,"city":72,"state":73,"zip":74,"country":75,"contacts":76,"geoPoint":82},"Washington University, St. Louis","St Louis","Missouri","63130","United States",[77],{"name":78,"role":79,"phone":80,"email":81},"Ismael Seáñez, PhD","CONTACT","314-935-7665","ismaelseanez@wustl.edu",{"lat":83,"lon":84},38.62727,-90.19789,[86,87],{"name":78,"role":79,"phone":80,"email":81},{"name":88,"role":79,"phone":89,"email":90},"Carolyn Atkinson, BS","314-935-4530","a.carolyn@wustl.edu",[],[],[],{"nct_id":4,"conditions":95,"biomarkers":97},[96],"Spinal Cord Injury",[],{"nct_id":4,"found":99,"summary":100,"prompt_version":110},true,{"design":101,"status":102,"heading":103,"summary":104,"follow_up":105,"word_count":106,"commitments":107,"compensation":108,"drugs_mentioned":109},"This interventional study plans to enroll 48 participants. It will compare three different approaches: no stimulation, conventional tSCS, and spatiotemporal tSCS.","completed","Spatiotemporal tSCS for Spinal Cord Injury","This study is looking at new ways to use transcutaneous spinal cord stimulation (tSCS) to help people with spinal cord injuries (SCI) regain movement in their legs. tSCS uses electrodes on the skin to deliver electrical pulses to the spinal cord. Researchers want to see if changing the way the stimulation is delivered – by varying electrode location, frequency, and strength – can better target specific muscles and improve leg movements. The study will compare this 'Spatiotemporal tSCS' to 'Conventional tSCS' and no stimulation. They will measure changes in leg muscle strength (torque) after 30 minutes to see if the new method is more effective. You may be able to join if you are 16-65 years old, have a chronic SCI (at least one year old) affecting C3-T12, and can voluntarily move at least two leg muscles. The current status of this study is unclear.","The primary outcome is measured at 30 minutes, but the overall follow-up duration is not specified.",145,"Participants will complete motor tasks and assessments while receiving different types of spinal cord stimulation or no stimulation.","Not stated in the trial record.",[33,39,43],"v2"]