[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100580737":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":30,"centralContacts":34,"locations":40,"responsibleParty":54,"collaborators":24,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":24,"eligibilityCriteria":63,"healthyVolunteers":64,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":24,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":80,"overallStatus":42,"whyStopped":24,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Kessler Foundation","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"Testing position and cooling modality for the ice test","As a spin-off of the main study, we aim to determine which cooling modality and body position elicit the most consistent and stable blood pressure response. To do so, we conduct a supplementary experiment involving 5 individuals with chronic SCI and 5 able-bodied controls. Each participant completes two experimental sessions: one in the supine position and one in the seated position. Within each session, participants undergo two tests, separated by a 30-minute rest period:\n\n1. an ice-water immersion test, in which the foot is submerged in ice water for 3 minutes, and\n2. an ice-wrap test, in which ice packs are applied around the foot and ankle for 3 minutes.\n\nThe order of body position and cooling modality is pseudo-randomized. Throughout each test, blood pressure is continuously recorded, and participants rate discomfort or pain at 1-minute intervals.",[12],"Procedure: Ice testing",{"label":14,"type":6,"description":15,"interventionNames":16},"Main study: assessing the BP changes throughout the first year post SCI","The main study recruits 5 individuals with sub-acute SCI and follows them for one year to evaluate how blood pressure responses evolve during the early post-injury period.",[17],"Device: spinal cord transcutaneous stimulation",[19,25],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","spinal cord transcutaneous stimulation","Stimulation, using the Neostim-5 (Cosyma Ltd.), a 5-channel electrical stimulator, will be administered throughout the study period, beginning shortly after the injury and continuing at regular intervals until one year post-spinal cord injury. It will be performed in two settings:\n\n1. During seated mapping to identify stimulation sites (potentially T7\u002F8, T11\u002F12, L1\u002F2, and S1\u002F2) and determine stimulation parameters (e.g., frequency, pulse wave, amplitude) that elevate systolic blood pressure (SBP) and maintain it within the target range of 110-120 mmHg.\n2. During 70-degree tilt tests to elicit an orthostatic response (a drop in blood pressure accompanied by symptoms).",[14],null,{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":24},"PROCEDURE","Ice testing","Ice testing is performed using either a 3-minute ice-water immersion or a 3-minute ice-wrap application surrounding the foot. Each participant undergoes both the ice-water and ice-wrap conditions within the same session, separated by a 30-minute interval to allow the foot to return to baseline. Testing is conducted in both the seated and supine positions across two separate sessions, with both the cooling modality and body position randomized.",[9],[31],{"name":32,"affiliation":5,"role":33},"Einat Engel-Haber, MD","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":24,"email":39},"Leighann Martinez, BA","CONTACT","(973)324-3557","lmartinez@kesslerfoundation.org",[41],{"facility":5,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":24},"RECRUITING","West Orange","New Jersey","07052","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-74.23904,40.79871,{"lat":52,"lon":51},{"type":33,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Einat Haber","Associate Research Scientist","100580737","cardiovascular-function-and-response-to-stimulation-within-the-first-year-after-spinal-cord-injury-100580737",false,"NCT06841198","Cardiovascular Function and Response to Stimulation Within the First Year After Spinal Cord Injury","Assessing Cardiovascular Effects: Is There a Time Too Early for Spinal Stimulation in Acute SCI? A Year-Long Evaluation of Autonomic Function Following Injury","For the main study:\n\nInclusion Criteria:\n\n* Individuals with a spinal cord injury undergoing inpatient rehabilitation at the Kessler Institute for Rehabilitation\n* Between 18-75 years old\n* 7-50 days after injury\n* Injury level ≥ T6 (a cervical or a high-level chest injury)\n* Individuals experiencing low blood pressure after the injury\n* American Spinal Injury Association Impairment Scale (AIS) A or B\n\nExclusion Criteria:\n\n* A ventilator is needed for breathing.\n* Devices such as brain\u002Fspine\u002Fnerve stimulators, a cardiac pacemaker\u002Fdefibrillator, or intra-cardiac lines are present in the body.\n* There is a significant disease affecting the blood vessels or signals in the heart, or a recent heart attack (myocardial infarction) has occurred.\n* A new medication has been prescribed to treat blood pressure or a heart problem within the last five days (excluding midodrine).\n* There is a known infection in the body (e.g., urinary tract infection) or a current illness (e.g., recent diagnosis of deep vein thrombosis (DVT) or other blood clotting issues, and\u002For a pressure injury that might interfere with the study).\n* There is a history of seizures.\n* Pregnancy.\n\nFor the spin-off study ice-water vs ice-wrap test (see description in study arms):\n\n\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\n\nInclusion:\n\nAge 18-75.\n\nInclusion for individuals with SCI:\n\n* Injury sustained more than 6 months ago\n* Injury level ≥ T6 (a cervical or a high-level chest injury)\n* American spinal injury association impairment scale (AIS) A - D\n\nExclusion:\n\nFoot lesions, uses a ventilator, devices such as brain\u002Fspine\u002Fnerve stimulators, significant or recent cardiovascular disease, known infection in the body",true,"ALL","18 Years","75 Years",{"count":69,"type":70},15,"ESTIMATED","INTERVENTIONAL",[73],"NA","The study aims to explore how cardiovascular function changes in the first year after a spinal cord injury, and to see how different treatments, like spinal stimulation through the skin (transcutaneous spinal stimulation), affect blood pressure.\n\nThe main questions are:\n\nHow does stimulation affect blood pressure over the year? What is the level of cardiovascular activation throughout the year?\n\nThe study will start during the inpatient stay at the Kessler Institute for Rehabilitation and continue after discharge as an outpatient, totaling about 20-29 sessions over the year.",[76,77,78,79],"Spinal Cord Injuries (SCI)","Orthostatic Hypotension, Dysautonomic","Cardiovascular","Transcutaneous Spinal Stimulation",[81,82,83,84,85,86,87,88,89,90,91,92,93],"Transcutaneous Spinal Cord Stimulation","spinal cord stimulation","orthostatic hypotension","blood pressure","cardiovascular","neuromodulation","acute spinal cord injury","chronic spinal cord injury","inpatient rehabilitation","tilt testing","cold pressor test","ambulatory blood pressure monitoring","autonomic dysfunction following spinal cord injury","2026-06-26",{"date":96,"type":97},"2026-07-01","ACTUAL",{"date":99,"type":97},"2025-04-01",{"date":101,"type":70},"2026-11",{"name":5,"class":6},1]