[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05556902":3,"trial-entities:NCT05556902":84,"trial-summary:NCT05556902":88},{"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":21,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":40,"secondary_outcomes":47,"sex":48,"minimum_age":49,"maximum_age":50,"healthy_volunteers":14,"eligibility_criteria":51,"std_ages":55,"locations":58,"central_contacts":73,"overall_officials":78,"references":82,"see_also_links":83},"NCT05556902","IRB-300009200","Therapeutic Mechanisms of Epidural Spinal Cord Stimulation","RECRUITING","2030-05-01","2026-08","2026-08-11","2022-08-02","University of Alabama at Birmingham","OTHER",false,"The purpose of this study in patients undergoing routine care epidural spinal cord stimulation (SCS) is to determine 1) whether SCS reduces arterial blood pressure (BP) in patients which chronic low back pain and hypertension, 2) whether higher baseline BP (i.e., hypertension) predicts reductions in pain following SCS, and finally 3) whether different SCS waveforms elicits stimulus-evoked compound action potentials (ECAPs) in spinal cord and at the cortex (electroencephalography, and magnetoenchphalography).","The purpose of this study in patients undergoing routine care epidural spinal cord stimulation (SCS) is to determine 1) whether SCS reduces arterial blood pressure (BP) in patients which chronic low back pain and hypertension, 2) whether higher baseline BP (i.e., hypertension) predicts reductions in pain following SCS, and finally 3) whether different SCS waveforms elicits stimulus-evoked compound action potentials (ECAPs) in spinal cord and at the cortex (electroencephalography, and magnetoenchphalography).\n\nThe Investigators will identify patients with chronic pain who are scheduled for SCS implant at the University of Alabama at Birmingham for management of chronic neuropathic pain as part of routine care. The research team will assess BP with an arm cuff arm cuff before and after the implant among patients providing written informed consent.\n\nThe Investigators' central clinical hypothesis is that SCS decreases blood pressure in patients with chronic pain and comorbid hypertension. The Investigators further hypothesize that the SCS will improve serological markers of sympathetic nerve activity and kidney function, possibly due to reductions in spinal cord sympathetic nerve activity. A secondary hypothesis is that higher baseline blood pressure predicts larger reductions in blood pressure following SCS implant.\n\nAdditionally, this project seeks to expand knowledge on therapeutic mechanisms of SCS via recording electrophysiological responses at the spinal cord (via adjacent, unused SCS contacts) and from EEG scalp recordings over the cerebral cortex.",[18,19,20],"Blood Pressure","Low Back Pain","Hypertension",[22,23,24,25],"Spinal Cord Stimulation","Epidural Spinal Cord Stimulation","SCS","Arterial Blood Pressure","INTERVENTIONAL","TREATMENT",[29],"NA",{"count":31,"type":32},80,"ESTIMATED",[34],{"type":35,"name":36,"description":37,"armGroupLabels":38},"DEVICE","Permanent Epidural Spinal Cord Stimulation","Permanent Spinal Cord Stimulation implanted in participants undergoing routine care for management of chronic neuropathic pain.",[39],"Treatment",[41,45],{"measure":42,"description":43,"timeFrame":44},"Arterial Blood Pressure Change","The research team will assess systolic and diastolic blood pressure with an arm cuff.","Baseline (1 week pre-op)",{"measure":42,"description":43,"timeFrame":46},"Visit 2 (4-6 weeks post-op)",[],"ALL","18 Years","89 Years",{"inclusion":52,"exclusion":53,"raw_text":54},[],[],"Inclusion Criteria:\n\n1. Male or Female, age 18-89\n2. Chronic pain for more than 3 months\n3. Willing to visit a research lab\n4. Willing to undergo a blood draw\n5. Able to provide written informed consent\n\nExclusion Criteria\n\n1. History of neurological disease (e.g., dementias, Parkinson's)\n2. History of stroke\n3. Current diagnosis of cancer\n4. Subject is unwilling or unable to comply with the protocol",[56,57],"ADULT","OLDER_ADULT",[59],{"facility":12,"status":7,"city":60,"state":61,"zip":62,"country":63,"contacts":64,"geoPoint":70},"Birmingham","Alabama","35233","United States",[65],{"name":66,"role":67,"phone":68,"email":69},"Marshall Holland, MD","CONTACT","2059342654","mtholland@uabmc.edu",{"lat":71,"lon":72},33.52066,-86.80249,[74],{"name":75,"role":67,"phone":76,"email":77},"Chris Gonzalez, MS","(205) 975-3732","clgonzalez@uabmc.edu",[79],{"name":66,"affiliation":80,"role":81},"The University of Alabama at Birmingham","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":85,"biomarkers":87},[20,86],"Lower Back Pain",[],{"nct_id":4,"found":89,"summary":90,"prompt_version":100},true,{"design":91,"status":92,"heading":93,"summary":94,"follow_up":95,"word_count":96,"commitments":97,"compensation":98,"drugs_mentioned":99},"This interventional study plans to enroll 80 participants. It is not specified if it is randomized or blinded.","completed","Epidural Spinal Cord Stimulation for Blood Pressure and Pain","This study is looking at how permanent epidural spinal cord stimulation (SCS), a device implanted for chronic pain, might affect blood pressure. Researchers want to see if SCS can lower high blood pressure in people who also have chronic low back pain. They are also investigating if having higher blood pressure before SCS predicts better pain relief, and how different SCS settings affect brain and spinal cord activity. You might be able to join if you are between 18 and 89 years old, have chronic pain for over three months, and are scheduled for an SCS implant as part of your regular care. You cannot join if you have certain neurological conditions, a history of stroke, or cancer. The study aims to enroll 80 participants.","Your blood pressure will be measured at baseline (1 week before surgery) and again 4-6 weeks after your SCS implant.",125,"You would visit a research lab and have a blood draw. Your blood pressure will be measured before and 4-6 weeks after your SCS implant.","Not stated in the trial record.",[36],"v2"]