[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631697":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":29,"centralContacts":33,"locations":42,"responsibleParty":71,"collaborators":73,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":28,"eligibilityCriteria":82,"healthyVolunteers":78,"sex":83,"minAge":84,"maxAge":28,"enrollmentInfo":85,"targetDuration":28,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":28,"overallStatus":62,"whyStopped":28,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"University of Louisville","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"CV-scTS 1","ACTIVE_COMPARATOR","The participants in this arm will receive spinal cord stimulation at the thoracolumbar level (T10 to L1 spinal cord levels) targeted for blood pressure regulation. There will be mapping sessions where stimulation will be provided to assess the impact on functional outcomes and to refine stimulation parameters for training. Using multi-variant combinations of electrode locations and different electrical configurations, the stimulation will be delivered with frequency of up to 100 Hz, with incrementally increased intensity up to 200mA. During stimulation interventions, 5 mA-sub-motor threshold intensity with mapping-identified frequency, pulse width, and intensity will be delivered during interventional bouts.",[13],"Device: Spinal Cord Transcutaneous Stimulation",{"label":15,"type":10,"description":16,"interventionNames":17},"CV-scTS 2","The participants in this arm will receive spinal cord stimulation at the lumbosacral level (L1 to S1 spinal cord levels) targeted for blood pressure regulation. There will be mapping sessions where stimulation will be provided to assess the impact on functional outcomes and to refine stimulation parameters for training. Using multi-variant combinations of electrode locations and different electrical configurations, the stimulation will be delivered with frequency of up to 100 Hz, with incrementally increased intensity up to 200mA. During stimulation interventions, 5 mA-sub-motor threshold intensity with mapping-identified frequency, pulse width, and intensity will be delivered during interventional bouts.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Resp-scTS","Qualifying participants of NCT06019949 (IRB #23.0570) randomized to the respiratory stimulation alone intervention group (Resp-scTS) will be invited to participate in this study to collect additional outcome measures. Overlapping assessments will be shared between the two studies. Participants in this arm will receive spinal cord stimulation at the thoracic level (T1 to T9 spinal cord levels) targeted for respiratory function. There will be mapping sessions where stimulation will be provided to assess the impact on functional outcomes and to refine stimulation parameters for training. Using multi-variant combinations of electrode locations and different electrical configurations, the stimulation will be delivered with frequency of up to 100 Hz, with incrementally increased intensity up to 200mA. During stimulation interventions, 5 mA-sub-motor threshold intensity with mapping-identified frequency, pulse width, and intensity will be delivered during interventional bouts.",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DEVICE","Spinal Cord Transcutaneous Stimulation","Spinal Cord Transcutaneous Stimulation (scTS) will be administered using the Biostim\u002FNeostim (Cosyma Inc., Denver CO) device. Up to six pairs of self-adhesive conductive electrodes will be placed on the skin over the spinal cord (midline and\u002For just to the left and right of midline) as cathodes and up to six pairs of self-adhesive electrodes located symmetrically on the skin over the iliac crests, clavicles, shoulders, and\u002For abdominal muscles (left and right of the umbilicus) as anodes. During scTS mapping sessions, stimulation will be provided to assess the impact on functional outcomes and to refine stimulation parameters for training (e.g., blood pressure modulation, respiratory function) targeted for each arm. Using multi-variant combinations of electrode locations and different electrical configurations, the stimulation will be delivered at a level specific to each arm with frequency of up to 100 Hz, with incrementally increased intensity up to 200 mA.",[9,15,19],null,[30],{"name":31,"affiliation":5,"role":32},"Alexander Ovechkin","PRINCIPAL_INVESTIGATOR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":28,"email":38},"Andrea M Willhite","CONTACT","1-502-581-8675","andrea.willhite@louisville.edu",{"name":40,"role":36,"phone":37,"phoneExt":28,"email":41},"Kristin Benton","kristin.benton@louisville.edu",[43,60],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Frazier Rehabilitation and Neuroscience Institute","NOT_YET_RECRUITING","Louisville","Kentucky","40202","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-85.75941,38.25424,{"lat":55,"lon":54},[58],{"name":35,"role":36,"phone":59,"phoneExt":28,"email":38},"502-582-8675",{"facility":61,"status":62,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":63,"geoPoint":65,"contacts":66},"Frazier Rehabilitation Institute","RECRUITING",{"type":52,"coordinates":64},[54,55],{"lat":55,"lon":54},[67,69],{"name":68,"role":36,"phone":59,"phoneExt":28,"email":38},"Andrea Willhite, MS",{"name":70,"role":32,"phone":28,"phoneExt":28,"email":28},"Alexander V Ovechkin, MD, PhD",{"type":32,"investigatorFullName":70,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"Professor",[74],{"name":75,"class":6},"Kentucky Spinal Cord and Head Injury Research Board","100631697","non-invasive-spinal-cord-stimulation-and-blood-pressure-regulation-after-spinal-cord-injury-100631697",false,"NCT07504055","Non-invasive Spinal Cord Stimulation and Blood Pressure Regulation After Spinal Cord Injury","Effectiveness of Transcutaneous Spinal Cord Stimulation on Blood Pressure Regulation in Individuals With Chronic Spinal Cord Injury","Inclusion Criteria:\n\n* At least 18 years old,\n* Stable medical condition,\n* Non-progression SCI (no negative change in the neurological level and motor-completeness assess during screening when compared to the neurological status assessed at 6-month period after injury or at least 6 months prior to the screening),\n* Motor-complete SCI according to the American Spinal Injury Association (ASIA) Impairment Scale (AIS) grade \"A,\" \"B,\" or \"C\" above T1 spinal level according to the ASIA International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Neurological Level of Injury (NLI),\n* Sustained SCI at least 12 months prior to entering the study,\n* Evidence of symptomatic hypotension as determined by a total score \\>0 on the Orthostatic Hypotension Symptom Assessment (OSHA),\n* Normal renal function as defined by eGFR \\> 59 ml\u002Fmin\u002F1.73, creatinine value within the range of 0.6-1.2 mg\u002Fdl, and BUN values within the range of 7-18 mg\u002Fdl,\n* Competent to give informed consent for the research protocol,\n* Able to understand instructions.\n\nExclusion Criteria:\n\n* Major pulmonary or cardiovascular disease unrelated to SCI,\n* Ventilator dependence,\n* Painful musculoskeletal dysfunction that might interfere with testing or stimulation,\n* Unhealed fracture that might interfere with testing or stimulation,\n* Unhealed contracture that might interfere with testing or stimulation,\n* Unhealed pressure sore that might interfere with testing or stimulation,\n* Untreated clinically significant depression or psychiatric disorders,\n* Ongoing drug abuse,\n* Malignancy ,\n* Class III obesity (BMI \\>40) and at least one co-morbidity thereof: a) Type 2 diabetes as defined by ≥6.5% level on two separate glycated hemoglobin (A1C) tests, b) hypertension as defined by consistent blood pressure readings of ≥140\u002F90 mmHg or taking medication for blood pressure,\n* Acute or chronic obstructive deep vein thrombosis,\n* Secondary hypotension unrelated to SCI (anemia, hypervolemia, endocrine and neurological diseases),\n* Major esophageal\u002Fgastrointestinal problem,\n* Currently pregnant (females of childbearing potential only),\n* Other major medical illness contraindicated for testing or stimulation.","ALL","18 Years",{"count":86,"type":87},40,"ESTIMATED","INTERVENTIONAL",[90],"NA","The goal of this clinical trial is to learn if non-invasive spinal cord stimulation intervention improves blood pressure regulation in individuals with chronic spinal cord injury. The main questions it aims to answer are:\n\n* Can site specific spinal cord stimulation enhance blood pressure regulation?\n* Does this stimulation affect enzymes responsible for blood pressure regulation? Researchers will stimulate different sites of spinal cord and compare to see if site-specific stimulation provide blood pressure stability.\n\nParticipants will have up to six pairs of self-adhesive conductive electrodes placed on the skin over the spinal cord (midline and\u002For just to the left and right of midline) as cathodes and up to six pairs of self-adhesive electrodes located symmetrically on the skin over the iliac crests, clavicles, shoulders, and\u002For abdominal muscles (left and right of the umbilicus) as anodes for stimulation of the spinal cord.",[93,94,95],"Spinal Cord Injury","Orthostatic Hypertension","Autonomic Dysreflexia","2026-04-27",{"date":98,"type":99},"2026-04-28","ACTUAL",{"date":101,"type":99},"2026-04-01",{"date":103,"type":87},"2029-02",{"name":5,"class":6},2]