[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04493372":3,"trial-entities:NCT04493372":113,"trial-summary:NCT04493372":117},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":46,"secondary_outcomes":51,"sex":71,"minimum_age":72,"maximum_age":73,"healthy_volunteers":74,"eligibility_criteria":75,"std_ages":88,"locations":90,"central_contacts":105,"overall_officials":107,"references":111,"see_also_links":112},"NCT04493372","23-005772","Deciphering Preserved Autonomic Function After Spinal Cord Injury","RECRUITING","2026-09-08","2026-04","2026-05-28","2020-11-13","Mayo Clinic","OTHER",false,"This study looks to characterize gradients of dysfunction in the autonomic nervous system after spinal cord injury. The autonomic nervous system plays key roles in regulation of blood pressure, skin blood flow, and bladder health- all issues that individuals with spinal cord injury typically suffer. Focusing on blood pressure regulation, the most precise metric with broad clinical applicability, the investigators will perform laboratory-based tests to probe the body's ability to generate autonomic responses. For both individuals with spinal cord injury and uninjured controls, laboratory-based experiments will utilize multiple parallel recordings to identify how the autonomic nervous system is able to inhibit and activate signals. The investigators anticipate that those with autonomic dysfunction after spinal cord injury will exhibit abnormalities in these precise metrics. The investigators will further have research participants wear a smart watch that tracks skin electrical conductance, heart rate, and skin temperature, which can all provide clues as to the degree of autonomic dysfunction someone may suffer at home. The investigators will look to see if any substantial connections exist between different degrees of preserved autonomic function and secondary autonomic complications from spinal cord injury. In accomplishing this, the investigators hope to give scientists important insights to how the autonomic nervous system works after spinal cord injury and give physicians better tools to manage these secondary autonomic complications.","This study looks to characterize gradients of dysfunction in the autonomic nervous system after spinal cord injury. To accomplish this, we are enrolling both individuals with and without spinal cord injuries (see inclusion criteria). Individuals will undergo the listed diagnostics as part of a battery of laboratory testing. These will be correlated to clinical histories of autonomic dysfunction the ADFSCI and COMPASS-31 surveys (noted in outcome measures).",[18,19,20,21],"Spinal Cord Injuries","Autonomic Imbalance","Autonomic Dysreflexia","Orthostatic Hypotension",[],"INTERVENTIONAL","DIAGNOSTIC",[26],"NA",{"count":28,"type":29},69,"ESTIMATED",[31,38,42],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DIAGNOSTIC_TEST","Tests of sympathetic inhibition","Bolus phenylephrine infusion using the Oxford technique will generate the need to inhibit sympathetic activity. Similarly, resting state Mayer waves will be assessed with regard to heart rate and blood pressure responses.",[36,37],"Individuals with spinal cord injury","Individuals without spinal cord injury",{"type":32,"name":39,"description":40,"armGroupLabels":41},"Tests of sympathetic activation","Cold pressor test of the hand will be used to cause sympathetic activation. Valsalva's maneuver will assess the ability to buffer against blood pressure fall (phase II).",[36,37],{"type":32,"name":43,"description":44,"armGroupLabels":45},"Testing of autonomic dysreflexia","Cold pressor test of the foot and bladder pressor response (in individuals with SCI) will be tested.",[36,37],[47],{"measure":48,"description":49,"timeFrame":50},"Valsalva Maneuver Phase II","Presence or absence of phase II on Valsalva maneuver testing, which takes approximately 15 seconds to complete. This will be repeated x3.","During laboratory diagnostic testing session",[52,55,58,61,64,68],{"measure":53,"description":54,"timeFrame":50},"Beat-to-beat heart rate","Electrocardiogram will record continuous measures with changes in R-R interval (ms) quantified and compared to baseline.",{"measure":56,"description":57,"timeFrame":50},"Beat-to-beat blood pressure","Non-invasive continuous blood pressure monitors will be used, with changes in systolic and diastolic pressure (in mmHg) from resting baseline measured.",{"measure":59,"description":60,"timeFrame":50},"Continuous galvanic skin response","Changes from resting state conductance with be quantified with a smartwatch.",{"measure":62,"description":63,"timeFrame":50},"Continuous wrist temperature","Changes from resting state temperature with be quantified with a smartwatch.",{"measure":65,"description":66,"timeFrame":67},"Quantify autonomic dysreflexia and orthostatic hypotension","Participants will be given the Autonomic Dysfunction Following Spinal Cord Injury questionnaire (score range 0-436, with higher scores indicating more autonomic dysfunction).","Baseline, prior to laboratory diagnostic testing session",{"measure":69,"description":70,"timeFrame":67},"Quantify secondary autonomic complications","Participants will be given the Composite Autonomic Symptom Score (range 0-100, with higher scores indicating more autonomic dysfunction).","ALL","18 Years","50 Years",true,{"inclusion":76,"exclusion":80,"raw_text":87},[77,78,79],"Adult onset, traumatic spinal cord injury.","American Spinal Injury Association Impairment Scale, A-D, to encompass a spectrum of autonomic dysfunction after spinal cord injury.","Neurological level of injury, C1-T12, as defined by the International Standards for Neurological Classification of Spinal Cord Injury. Incorporating level of injury down to T12 to encompass a broad range of autonomic dysfunction.",[81,82,83,84,85,86],"History of cardiovascular disease, hypertension, neurologic disorders (with exception of spinal cord injury), or diabetes.","Women who are pregnant or lactating.","Currently taking blood thinners.","Pacemaker, implanted defibrillator, or intrathecal pump incompatible with MRI scanning.","Cognitive issues preventing informed consent for participation.","Body mass index \\>30 kg\u002Fm2 for controls, in an effort to limit effects of early cardiovascular disease and diabetes in control population. Body mass index has not proven to be a good estimate of these factors following spinal cord injury.","Inclusion Criteria:\n\nAll subjects\n\n\\- age 18-50 years old.\n\nParticipants with spinal cord injury\n\n* Adult onset, traumatic spinal cord injury.\n* American Spinal Injury Association Impairment Scale, A-D, to encompass a spectrum of autonomic dysfunction after spinal cord injury.\n* Neurological level of injury, C1-T12, as defined by the International Standards for Neurological Classification of Spinal Cord Injury. Incorporating level of injury down to T12 to encompass a broad range of autonomic dysfunction.\n\nExclusion Criteria:\n\n* History of cardiovascular disease, hypertension, neurologic disorders (with exception of spinal cord injury), or diabetes.\n* Women who are pregnant or lactating.\n* Currently taking blood thinners.\n* Pacemaker, implanted defibrillator, or intrathecal pump incompatible with MRI scanning.\n* Cognitive issues preventing informed consent for participation.\n* Body mass index \\>30 kg\u002Fm2 for controls, in an effort to limit effects of early cardiovascular disease and diabetes in control population. Body mass index has not proven to be a good estimate of these factors following spinal cord injury.",[89],"ADULT",[91],{"facility":12,"status":7,"city":92,"state":93,"zip":94,"country":95,"contacts":96,"geoPoint":102},"Rochester","Minnesota","55902","United States",[97],{"name":98,"role":99,"phone":100,"email":101},"Erin Lund","CONTACT","507-284-9298","lund.erin@mayo.edu",{"lat":103,"lon":104},44.02163,-92.4699,[106],{"name":98,"role":99,"phone":100,"email":101},[108],{"name":109,"affiliation":12,"role":110},"Ryan Solinsky, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":114,"biomarkers":116},[115],"Spinal Cord Injury",[],{"nct_id":4,"found":74,"summary":118,"prompt_version":128},{"design":119,"status":120,"heading":121,"summary":122,"follow_up":123,"word_count":124,"commitments":125,"compensation":126,"drugs_mentioned":127},"This interventional study plans to enroll 69 participants, including individuals with and without spinal cord injuries. It is not specified if the study is randomized or blinded.","completed","Understanding Autonomic Function After Spinal Cord Injury","This study aims to understand how the autonomic nervous system (which controls automatic body functions like blood pressure and heart rate) works after a spinal cord injury. Researchers will use tests like a bolus phenylephrine infusion (a medicine that affects blood pressure), a cold pressor test (placing a hand or foot in cold water), and Valsalva's maneuver (a breathing technique) to see how your body responds. The main goal is to measure how well your body can adjust blood pressure using Valsalva's maneuver. You may be able to join if you are between 18 and 50 years old and have a traumatic spinal cord injury. The study is currently unclear on its recruitment status and plans to enroll 69 participants.","Not specified.",120,"You will undergo laboratory-based diagnostic tests, including a bolus phenylephrine infusion, cold pressor tests of the hand and foot, and Valsalva's maneuver. The Valsalva Maneuver Phase II will be measured during these diagnostic testing sessions.","Not stated in the trial record.",[],"v2"]