[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100513052":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":39,"locations":50,"responsibleParty":70,"collaborators":69,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":69,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":69,"enrollmentInfo":82,"targetDuration":69,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":53,"whyStopped":69,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"James J. Peters Veterans Affairs Medical Center","FED",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Transcutaneous Spinal Cord Stimulation","EXPERIMENTAL","The transcutaneous spinal cord stimulation used in this experiment is specific to each participant as determined in a previous study. Possible parameters include biphasic or monophasic, Russian or Nonrussian, a variety of pulse widths, and location of stimulation (T7-8, T9-10,- T11-12, L1-2). The amplitude of the stimulation also depends on the results of the mapping study. This stimulation will be delivered 30 minutes at a time.",[13],"Other: Transcutaneous Spinal Cord Stimulation (TSCS)",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham Transcutaneous Spinal Cord Stimulation","SHAM_COMPARATOR","The sham stimulation will follow the above parameters but will only be delivered for a minute rather than the full 30 minutes.",[19],"Other: Sham Transcutaneous Spinal Cord Stimulation",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"OTHER","Transcutaneous Spinal Cord Stimulation (TSCS)","This is electrical stimulation delivered to the spinal cord through the skin and tissue using a cathode electrode to deliver the stimulation and anode electrodes to ground the circuit.",[9],[27],"transcutaneous spinal stimulation (TSS)",{"type":22,"name":15,"description":29,"armGroupLabels":30,"otherNames":31},"This is designed to appear like transcutaneous spinal cord stimulation without actually delivering the stimulation.",[15],[32,33,34],"Sham Transcutaneous Spinal Stimulation","Placebo Transcutaneous Spinal Stimulation","Placebo Transcutaneous Spinal Cord Stimulation",[36],{"name":37,"affiliation":5,"role":38},"Jill M Wecht, EdD","PRINCIPAL_INVESTIGATOR",[40,46],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},"Matthew T Maher, MS","CONTACT","(718) 584-9000","1706","Matthew.Maher@va.gov",{"name":47,"role":42,"phone":43,"phoneExt":48,"email":49},"Fiona E Fox, BS","3128","fefox16@gmail.com",[51],{"facility":52,"status":53,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"James J Peters VAMC","RECRUITING","The Bronx","New York","10468","United States","US",{"type":60,"coordinates":61},"Point",[62,63],-73.86641,40.84985,{"lat":63,"lon":62},[66,68],{"name":41,"role":42,"phone":67,"phoneExt":44,"email":45},"718-584-9000",{"name":37,"role":38,"phone":69,"phoneExt":69,"email":69},null,{"type":38,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":69,"oldOrganization":69},"Jill M. Wecht, Ed.D.","Principal Investigator","100513052","autonomic-effects-of-spinal-cord-stimulation-in-spinal-cord-injury-100513052",false,"NCT05960448","Autonomic Effects of Spinal Cord Stimulation in Spinal Cord Injury","Autonomic Effects of Transcutaneous Spinal Cord Stimulation in Veterans With Spinal Cord Injury (SCI)","Inclusion Criteria:\n\n* You are above the age of 18 years old\n* You have an SCI between C3-T6\n* You have been injured longer than 1 year\n* You participated in a prior experiment \"Targeted Transcutaneous Spinal Cord Stimulation to Restore Autonomic Cardiovascular Health in Individuals with Spinal Cord Injury\"\n* You have an American Spinal Injury Association injury classification scale (AIS) A, B, C\n* Your prescription medications have not changed for at least 30 days\n\nExclusion Criteria:\n\n* You have a history of seizures\n* You have an acute illness or infection\n* You have diabetes\n* You have untreated thyroid disease\n* You have a neurological condition other than SCI (Alzheimer's disease, dementia, stroke, multiple sclerosis, Parkinson's disease, etc.)\n* You have a history of heart or vascular disease (coronary artery disease, congestive heart failure, peripheral artery disease,)\n* You have a history of moderate or severe head trauma (TBI) or diagnosed with cognitive impairment\n* You have a present or history of a psychological disorder\n* You have contraindications to electricity over your spine\n* You are dependent on a ventilator to breathe or have an open tracheostomy site\n* You have a recent history of substance abuse (within the past 3 months)\n* You have open wounds over the spine at the level targeted for stimulation\n* You are pregnant","ALL","18 Years",{"count":83,"type":84},20,"ESTIMATED","INTERVENTIONAL",[87],"NA","The goal of this interventional crossover study is to determine the effects of transcutaneous spinal cord stimulation (TSCS) on the ability to perform moderate exercise and regulate core body temperature in the chronic spinal cord injury community. The main questions it aims to answer are:\n\n* What are the effects of active TSCS targeted for BP control on exercise endurance time and HR recovery during submaximal arm cycle ergometry (ACE) as compared to sham TSCS in participants with chronic, cervical SCI?\n* What are the effects of active TSCS on Tcore responses to cool ambient exposure and on subjective reporting of thermal comfort and thermal sensitivity as compared to sham TSCS.\n\nParticipants will receive sham and active stimulation while using an arm bicycle or while in a cold room. Participants are free to participate in either the exercise phase, the cold room phase, or both phases of this study.\n\nPlease note that there no expected long term benefits of this study.",[90],"Orthostatic Hypotension",[92,93,94,95,96,97],"neuromodulation","stimulation","exercise","hand bike","thermoregulation","cold room","2024-09-27",{"date":100,"type":101},"2024-10-01","ACTUAL",{"date":103,"type":101},"2023-07-30",{"date":105,"type":84},"2026-07-30",{"name":5,"class":6},1]