[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100545270":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":23,"centralContacts":27,"locations":34,"responsibleParty":48,"collaborators":32,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":32,"eligibilityCriteria":56,"healthyVolunteers":53,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":32,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":71,"overallStatus":81,"whyStopped":32,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"University of British Columbia","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Transcutaneous spinal cord stimulation (tSCS)","EXPERIMENTAL","Exploring the mechanisms of SCS for improving cardiovascular function in individuals with chronic, motor-complete SCI by measuring vascular related endothelial biomarkers and plasma catecholamines",[13],"Device: Transcutaneous Spinal Cord Stimulation (tSCS)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Transcutaneous Spinal Cord Stimulation (tSCS)","Transcutaneous spinal cord stimulation (tSCS) will be delivered via a non-invasive central nervous system stimulator TESCoN or SCONE (SpineX Inc., CA - experimental type II medical devices) through self-adhesive electrode(s) placed on the skin between spinous processes over the midline of the vertebral column as the cathode(s) and two rectangular electrodes placed symmetrically on the skin over the iliac crests as anodes. Stimulation will be applied at various waveforms and frequencies (ranging between 1Hz and 90Hz) with and without a carrier frequency. Current amplitude will start at 10mA and proceed incrementally until tolerable or responses plateau. If spasticity occurs or is uncomfortable, the current will be decreased. Specific areas for electrode placement will be examined and prepared to reduce skin impedance. tSCS will be delivered under the supervision of a physician (Dr. Krassioukov\u002FDr. Berger) by trained doctoral\u002Fpost-doctoral trainees.",[9],[21,22],"TESCoN device by SpineX Inc., CA, USA - experimental type II medical device","SCONE device by SpineX Inc., CA, USA - experimental type II medical device",[24],{"name":25,"affiliation":5,"role":26},"Andrei Krassioukov, MD,PhD,FRCPC","PRINCIPAL_INVESTIGATOR",[28],{"name":29,"role":30,"phone":31,"phoneExt":32,"email":33},"Andrea Maharaj, BSc","CONTACT","6046758856",null,"amaharaj@icord.org",[35],{"facility":36,"status":32,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":32},"Blusson Spinal Cord Centre","Vancouver","British Columbia","V5Z 1M9","Canada","CA",{"type":43,"coordinates":44},"Point",[45,46],-123.11934,49.24966,{"lat":46,"lon":45},{"type":26,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Andrei Krassioukov","Principal Investigator","100545270","cardiopulmonary-changes-following-spinal-cord-stimulation-in-individuals-with-spinal-cord-injury-100545270",false,"NCT06379711","Cardiopulmonary Changes Following Spinal Cord Stimulation in Individuals With Spinal Cord Injury","INCLUSION \\& EXCLUSION CRITERIA:\n\nINCLUSION CRITERIA:\n\nA participant must meet all of the following criteria in order to be eligible for inclusion:\n\n1. Resident of British Columbia, Canada with active provincial medical services plan\n2. Male or female, 19-65 years of age\n3. Chronic SCI at or above the T10 spinal cord segment\n4. \\>1-year post injury or diagnosis, at least 6 months from any spinal surgery.\n5. American Spinal Injury Association Impairment Scale (AIS) A, B, C and D for SCI\n6. Stable management of spinal cord related clinical issues (e.g., spasticity management)\n7. Women of childbearing potential must not be intending to become pregnant, currently pregnant, or lactating. The following conditions apply:\n\n   7.1 Women of childbearing potential must have a confirmed negative pregnancy test prior to the baseline visit.\n\n   7.2 Women of childbearing potential must agree to use adequate contraception during the period of the trial and for at least 28 days after completion of treatment. Effective contraception includes abstinence.\n8. Sexually active males with female partners of childbearing potential must agree to use effective contraception during the period of the trial and for at least 28 days after completion of treatment.\n9. Must provide informed consent.\n10. Able to understand and complete study-related questionnaires (must be able to understand and speak English or have access to an appropriate interpreter as judged by the investigator).\n11. Willing and able to comply with all clinic visits and study-related procedures.\n\nEXCLUSION CRITERIA:\n\nA participant who meets any of the following criteria will not be eligible to participate:\n\n1. Ventilator dependent.\n2. Painful musculoskeletal dysfunction, unhealed fracture, pressure sore, or active infection that may interfere with testing\n3. Clinically significant, unmanaged, depression (PHQ-9 above 15) or ongoing drug abuse.\n4. Use of any medication or treatment that in the opinion of the investigator indicates that it is not in the best interest of the participant to participate in this study.\n5. Intrathecal baclofen pump.\n6. Cardiovascular, respiratory, bladder, or renal disease unrelated to SCI or presence of hydronephrosis or presence of obstructive renal stones.\n7. Presence of severe acute medical issue(s) that in the investigator's judgement would adversely affect the participant's participation in the study (e.g., pressure sore, urinary tract infection, etc.).\n8. Any implanted metal (other than dental implants) in the skull or presence of pacemakers, stimulators, or medication pumps in the trunk.\n9. Severe anemia (Hgb\\\u003C8 g\u002Fdl) or hypovolemia as measured by hematocrit via blood test in the last six months.\n10. Participant has undergone electrode implantation surgery.\n11. Participant is a member of the investigational team or his\u002Fher immediate family.","ALL","19 Years","65 Years",{"count":61,"type":62},22,"ESTIMATED","INTERVENTIONAL",[65],"NA","The aim of this study is to examine the mechanisms of transcutaneous spinal cord stimulation (tSCS) for improving cardiovascular and pulmonary function in individuals with chronic motor-complete spinal cord injury (SCI) by measuring vascular related endothelial biomarkers, plasma catecholamines, and respiratory parameters.",[68,69,70],"Spinal Cord Injuries","Cardiovascular Diseases","Cardiopulmonary Diseases",[72,73,74,75,76,77,78,79,80],"Spinal Cord Stimulation","Transcutaneous Spinal Cord Stimulation","Cardiovascular dysfunction","Cardiopulmonary dysfunction","Cardiovascular Biomarkers","Endothelial cell-derived Microvesicles","Plasma Catecholamines","Autonomic Dysreflexia","Orthostatic Hypotension","NOT_YET_RECRUITING","2024-04-17",{"date":84,"type":85},"2024-04-23","ACTUAL",{"date":87,"type":62},"2024-08-01",{"date":89,"type":62},"2028-08-01",{"name":5,"class":6},1]