[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07674511":3,"trial-entities:NCT07674511":136,"trial-summary:NCT07674511":141},{"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":28,"study_type":34,"primary_purpose":35,"phases":36,"enrollment_info":38,"interventions":41,"primary_outcomes":52,"secondary_outcomes":60,"sex":79,"minimum_age":80,"maximum_age":81,"healthy_volunteers":82,"eligibility_criteria":83,"std_ages":100,"locations":103,"central_contacts":128,"overall_officials":132,"references":134,"see_also_links":135},"NCT07674511","R-1323-26","Impact of Transcutaneous Spinal Stimulation on Blood Pressure and Orthostasis in Spinal Cord Injury","Impact of Transcutaneous Spinal Stimulation on Blood Pressure and Orthostasis in Spinal Cord Injury: Short and Long-Term Effects","NOT_YET_RECRUITING","2028-12","2026-06","2026-06-29","2026-09","Kessler Foundation","OTHER",null,"The purpose of this study is to learn whether stimulation applied to the spinal cord through the skin (called transcutaneous spinal stimulation) can help control blood pressure in people with a spinal cord injury.\n\nThe main questions this study attempts to solve:\n\n1. What are the immediate effects of spinal cord transcutaneous stimulation on BP?\n2. Does stimulation produce lasting improvements in BP regulation and subsequently, daily function?","We want to find out if this stimulation can help both right away (during a session) and over time (after several sessions). Specifically, this study will look at whether spinal stimulation can treat orthostatic hypotension, which is a drop in blood pressure that happens when the patient moves from lying down to sitting or standing up. To take part, one must have had a spinal cord injury for more than one year.",[19,20,21,22,23,24,25,26,27],"Spinal Cord Injuries","Hypotension","Orthostatic Hypotension","Spinal Cord Diseases","Cardiovascular Diseases","Trauma, Nervous System","Central Nervous System Disease","Nervous System Diseases","Blood Pressure",[29,30,31,32,33],"transcutaneous spinal cord stimulation","spinal stimulations","orthostatic hypotension","blood pressure","neuromodulation","INTERVENTIONAL","TREATMENT",[37],"NA",{"count":39,"type":40},10,"ESTIMATED",[42,48],{"type":43,"name":44,"description":45,"armGroupLabels":46},"DEVICE","Tilt test with stimulation (real-time effects): Intervention 1","While lying supine, participants will be strapped to a Hi-Low tilt-table bed. The bed will gradually be tilted to a 70 degrees tilt, during which time continuous hemodynamic measures will be recorded. This position will be maintained for 30 minutes. During tilt, transcutaneous stimulation will be applied, using the configuration that was chosen based on the mapping sessions.",[47],"participants with chronic SCIs.",{"type":43,"name":49,"description":50,"armGroupLabels":51},"20 sessions of stimulation (Intervention 2)","Participants will undergo 20 separate 30-minute sessions of transcutaneous spinal cord stimulation while seated in their wheelchairs",[47],[53,57],{"measure":54,"description":55,"timeFrame":56},"Systolic blood pressure","Evaluate changes in blood pressure during an orthostatic tilt test comparing stimulation to no stimulation.","1 month",{"measure":54,"description":58,"timeFrame":59},"changes in blood pressure drop with tilt (no stimulation) from baseline testing to tilt test (no stimulation) after 20 sessions of stimulation","Through study completion, an average of 5 months",[61,64,67,70,73,76],{"measure":62,"description":63,"timeFrame":59},"duration in tilt test","how long the participant was able to stay in an orthostatic provocation (70 degrees tilt in tilt table)",{"measure":65,"description":66,"timeFrame":59},"Orthostatic symptoms questionnaire","A designated questionnaire evaluates symptoms such as headaches, dizziness, blurred vision, nausea, weakness, confusion, fatigue, ringing in the ears, and feeling of passing out. Recorded every 5 minutes (or sooner if symptoms worsen). Participants rate each symptom on a scale of 0 to 10, with 10 indicating the highest severity.",{"measure":68,"description":69,"timeFrame":59},"24-hour ABPM OH events - taken at home","Parameters are recorded automatically every 15 min during the day and every 60 min at night. Participants will be asked to take notes regarding BP-related symptoms, activities and their time-points. Conducted before, halfway through, and after the intervention",{"measure":71,"description":72,"timeFrame":59},"Autonomic Dysfunction Following Spinal Cord Injury questionnaire scores","24-item self-reported tool designed for clinical practice and research to assess symptoms of BP instability. It evaluates the frequency and severity of symptoms during high and low BP events",{"measure":74,"description":75,"timeFrame":59},"Spinal cord injury - quality of life scores","A questionnaire was developed to address the shortage of psychometrically sound and relevant patient-reported outcome measures for clinical care and research in SCI rehabilitation",{"measure":77,"description":78,"timeFrame":59},"Canadian Occupational Performance Measure scores","A semi-structure interview where the individual identifies and measures their areas of difficulty, scoring their performance on the tasks and their satisfaction with their ability","ALL","18 Years","75 Years",false,{"inclusion":84,"exclusion":89,"raw_text":99},[85,86,87,88],"Individuals with a SCI ≥ 1 year after injury","Injury level ≥ T6 (thoracic level)","AIS grade A-C","Cardiovascular dysfunction characterized by one or more of the following:",[90,91,92,93,94,95,96,97,98],"Current illness (e.g., infection, a pressure injury that might interfere with the intervention)","Ventilator-dependent","History of implanted brain\u002Fspine\u002Fnerve stimulators","Cardiac pacemaker\u002Fdefibrillator or intra-cardiac lines","Significant coronary artery or cardiac conduction disease, a recent history of myocardial infarction","History of seizures","pregnancy","Insufficient mental capacity to understand and independently provide consent","Deemed unsuitable by the study physician","Inclusion Criteria:\n\n* Individuals with a SCI ≥ 1 year after injury\n* Injury level ≥ T6 (thoracic level)\n* AIS grade A-C\n* Cardiovascular dysfunction characterized by one or more of the following:\n\n  1. Persistent hypotension (SBP \\\u003C 90mmHg)\n  2. Orthostatic hypotension (OH, a drop of 20\u002F10 mmHg in SBP\u002FDBP within 5 minutes of standing\u002Fupright positioning).\n\nAdditionally, experiencing orthostatic symptoms in daily life and\u002For requiring medication to manage OH.\n\nExclusion Criteria:\n\n* Current illness (e.g., infection, a pressure injury that might interfere with the intervention)\n* Ventilator-dependent\n* History of implanted brain\u002Fspine\u002Fnerve stimulators\n* Cardiac pacemaker\u002Fdefibrillator or intra-cardiac lines\n* Significant coronary artery or cardiac conduction disease, a recent history of myocardial infarction\n* History of seizures\n* pregnancy\n* Insufficient mental capacity to understand and independently provide consent\n* Deemed unsuitable by the study physician",[101,102],"ADULT","OLDER_ADULT",[104],{"facility":13,"city":105,"state":106,"zip":107,"country":108,"contacts":109,"geoPoint":125},"West Orange","New Jersey","07052","United States",[110,115,118,121,124],{"name":111,"role":112,"phone":113,"email":114},"LeighAnn Martinez, BA","CONTACT","(973)324-3557","lmartinez@kesslerfoundation.org",{"name":116,"role":112,"email":117},"Einat Engel-Haber, MD","ehaber@kesslerfoundation.org",{"name":119,"role":120},"Gail F Forrest, PhD","PRINCIPAL_INVESTIGATOR",{"name":122,"role":123},"Steven Kirshblum, MD","SUB_INVESTIGATOR",{"name":116,"role":123},{"lat":126,"lon":127},40.79871,-74.23904,[129,131],{"name":111,"role":112,"phone":130,"email":114},"972-324-3557",{"name":116,"role":112,"email":117},[133],{"name":119,"affiliation":13,"role":120},[],[],{"nct_id":4,"conditions":137,"biomarkers":140},[138,20,21,139],"Cardiovascular Dysfunction","Spinal Cord Injury",[],{"nct_id":4,"found":142,"summary":143,"prompt_version":153},true,{"design":144,"status":145,"heading":146,"summary":147,"follow_up":148,"word_count":149,"commitments":150,"compensation":151,"drugs_mentioned":152},"This interventional study plans to enroll 10 participants to test the effects of transcutaneous spinal stimulation.","completed","Transcutaneous Spinal Stimulation for Blood Pressure Control in Spinal Cord Injury","This study is investigating whether transcutaneous spinal stimulation, which involves applying electrical stimulation to the spinal cord through the skin, can help manage blood pressure in people with spinal cord injuries. Researchers want to see if this stimulation has immediate effects on blood pressure and if it can lead to lasting improvements, especially for orthostatic hypotension (a drop in blood pressure when moving from lying down to sitting or standing). You might be able to join if you are 18-75 years old, have had a spinal cord injury for at least one year, and experience persistent low blood pressure or orthostatic hypotension. The study aims to enroll 10 participants and will measure changes in systolic blood pressure to see if the treatment is successful.","Your systolic blood pressure will be measured at 1 month and again through study completion, which is an average of 5 months.",124,"You would undergo a tilt test with stimulation and participate in 20 separate 30-minute sessions of transcutaneous spinal cord stimulation while seated.","Not stated in the trial record.",[],"v2"]