[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100467649":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":35,"locations":45,"responsibleParty":78,"collaborators":81,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":25,"eligibilityCriteria":93,"healthyVolunteers":89,"sex":94,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":25,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":112,"overallStatus":48,"whyStopped":25,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"University of British Columbia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1 - Thoracic stimulation","EXPERIMENTAL","Participants will receive 8 weeks TCSCS at the mid\u002Flow thoracic spinal cord levels.",[13],"Device: TESCoN or SCONE device - Thoracic stimulation",{"label":15,"type":10,"description":16,"interventionNames":17},"Group 2- Lumbosacral stimulation","Participants will receive 8 weeks TCSCS at the lumbosacral spinal cord levels.",[18],"Device: TESCoN or SCONE device - Lumbosacral stimulation",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","TESCoN or SCONE device - Thoracic stimulation","TCSCS will be delivered using a non-invasive central nervous system stimulator (TESCoN or SCONE, SpineX Inc., CA, USA). The stimulation site will be over the thoracic spinal cord.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"TESCoN or SCONE device - Lumbosacral stimulation","TCSCS will be delivered using a non-invasive central nervous system stimulator (TESCoN or SCONE, SpineX Inc., CA, USA). The stimulation site will be over the lumbosacral spinal cord.",[15],[31],{"name":32,"affiliation":33,"role":34},"Andrei Krassioukov, MD, PhD, FRCPC","The University of British Columbia, International Collaboration on Repair Discoveries (ICORD)","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},"Andrea L. Maharaj, BSc","CONTACT","604-675-8856","AMaharaj@icord.org",{"name":42,"role":38,"phone":43,"phoneExt":25,"email":44},"Soshi Samejima, PhD","604 675 8816","soshi@icord.org",[46,67],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Blusson Spinal Cord Centre","RECRUITING","Vancouver","British Columbia","V5Z 1M9","Canada","CA",{"type":55,"coordinates":56},"Point",[57,58],-123.11934,49.24966,{"lat":58,"lon":57},[61,65],{"name":62,"role":38,"phone":63,"phoneExt":25,"email":64},"Andrea Maharaj, BSc","6046758856","amaharaj@icord.org",{"name":66,"role":34,"phone":25,"phoneExt":25,"email":25},"Andrei Krassioukov, MD,PhD,FRCPC",{"facility":68,"status":48,"city":49,"state":50,"zip":69,"country":52,"countryCode":53,"cosmosGeoPoint":70,"geoPoint":72,"contacts":73},"St Paul's Hospital","V6Z 1Y6",{"type":55,"coordinates":71},[57,58],{"lat":58,"lon":57},[74],{"name":75,"role":38,"phone":76,"phoneExt":25,"email":77},"Amandeep Ghuman, MD,MPH,FRCSC","604-806-8860","jennifer.phan@vch.ca",{"type":34,"investigatorFullName":79,"investigatorTitle":80,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Andrei Krassioukov","Professor",[82,85],{"name":83,"class":84},"United States Department of Defense","FED",{"name":86,"class":84},"Congressionally Directed Medical Research Programs","100467649","non-invasive-spinal-cord-stimulation-for-recovery-of-autonomic-function-after-spinal-cord-injury-100467649",false,"NCT05369520","Non-invasive Spinal Cord Stimulation for Recovery of Autonomic Function After Spinal Cord Injury","Non-invasive Spinal Cord Stimulation for Recovery of Autonomic Function After Spinal Cord Injury: Moving From Mechanisms to Clinical Practice","Inclusion Criteria:\n\n1. Resident of British Columbia, Canada with active provincial medical services plan.\n2. Male or female, 19-60 years of age.\n3. Chronic traumatic SCI (non-progressive, with complete motor paralysis) at or above the T6 spinal segment.\n4. \\>1-year post injury, at least 6 months from any spinal surgery.\n5. American Spinal Injury Association Impairment Scale (AIS) A, B.\n6. Stable management of spinal cord related clinical issues (i.e., spasticity management).\n7. Experience bladder, or bowel, or sexual dysfunction.\n8. No painful musculoskeletal dysfunction, unhealed fracture, pressure sore, or active infection that may interfere with testing.\n9. For women of childbearing potential, not intending to become pregnant, currently pregnant, or lactating. The following conditions apply:\n\n   1. A confirmed negative pregnancy test prior to the baseline visit. During the trial, all women of childbearing potential will undergo urine pregnancy tests at their monthly clinic visits as outlined in the schedule of events.\n   2. Use adequate contraception, or complete abstinence from sexual activities, during the period of the trial and for at least 28 days after completion of treatment.\n   3. If using combined hormonal contraception, a stable regimen during the period of the trial and for at least 28 days after completion of treatment.\n10. For sexually active males with female partners of childbearing potential, use adequate contraception, or complete abstinence from sexual activities, during the period of the trial and for at least 28 days after completion of treatment.\n11. Must provide informed consent.\n12. Willing and able to comply with all clinic visits and study-related procedures.\n13. 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).\n\nExclusion Criteria:\n\n1. Ventilator dependent.\n2. Signs of lower motor neuron damage (i.e. concomitant conus medullaris\u002Fcauda equina injury).\n3. Severe anemia or hypovolemia as measured by hematocrit via blood test in the last six months.\n4. History of cardiovascular, respiratory, bladder, or renal disease unrelated to SCI or presence of hydronephrosis or presence of obstructive renal stones.\n5. History of seizures\u002Fepilepsy or recurring headaches.\n6. Clinically significant, unmanaged, depression (to be screened) or ongoing drug abuse.\n7. Intrathecal baclofen pump.\n8. Oral baclofen dose greater than 60mg.\n9. Individuals that have received intradetrusor or intrasphincter onabotulinumtoxinA injections within 6 months of baseline.\n10. Any implanted metal (other than dental implants) in the skull or presence of pacemakers, stimulators, or medication pumps in the trunk.\n11. Past electrode implantation surgery.\n12. Member of the investigational team or his\u002Fher immediate family.\n13. Presence of severe acute medical issue and use of any specific medication or treatment that, in the investigator's judgement, would adversely affect the participant's participation in the study.\n14. Known allergies or sensitivities to both blue dye and beetroot powder.\n15. Known or suspected gastrointestinal obstruction.\n16. Persons with active inflammatory bowel disease or a history of bowel perforation.","ALL","19 Years","60 Years",{"count":98,"type":99},30,"ESTIMATED","INTERVENTIONAL",[102],"NA","This study is a pilot clinical trial to explore the efficacy of transcutaneous spinal cord stimulation (TCSCS) (proof-of-concept) in mitigating crucial autonomic dysfunctions that impact the health-related quality of life of individuals with spinal cord injury (SCI).",[105,106,107,108,109,110,111],"Spinal Cord Injury","Autonomic Dysfunction","Sexual Dysfunction","Neurogenic Bladder Dysfunction","Neurogenic Bowel Dysfunction","Autonomic Dysreflexia","Orthostatic Hypotension",[113,105],"Neurostimulation","2025-12-01",{"date":116,"type":117},"2025-12-08","ACTUAL",{"date":119,"type":117},"2023-10-03",{"date":121,"type":99},"2027-10",{"name":5,"class":6},2]