[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Saint Francis Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":66},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100535030","real-world-efficacy-of-evoke-closed-loop-spinal-cord-stimulation-cl-scs-therapy-in-chronic-pain-patients-ultra-100535030",false,"NCT06246526","Real-World Efficacy of Evoke® Closed-loop Spinal Cord Stimulation (CL-SCS) Therapy in Chronic Pain Patients (ULTRA).","ULTRA","Inclusion Criteria:\n\nBe 18 years of age or older at the time of enrollment.\n\nDiagnosed with chronic, intractable pain of the trunk and\u002For limbs, which has been refractory to conservative therapy for a minimum of 6 months.\n\nSubject has a minimum Visual Analog Scale (VAS) score of 60 mm or higher (where 100 mm indicates the worst imaginable pain) at baseline.\n\nBe an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician.\n\nBe willing and capable of giving informed consent.\n\nBe willing and able to comply with study-related requirements, procedures, and visits.\n\nExclusion Criteria:\n\nSubject is pregnant or nursing.\n\nHave a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, as determined by the Investigator.\n\nHave evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention, and\u002For ability to evaluate treatment outcomes.\n\nHave an existing drug pump and\u002For SCS system or another active implantable device such as a pacemaker, deep brain stimulator (DBS), or sacral nerve stimulator (SNS).\n\nHave prior experience with SCS.\n\nBe concomitantly participating in another clinical study.","ALL","18 Years",{"count":19,"type":20},50,"ESTIMATED","INTERVENTIONAL",[23],"NA","This observational, prospective data collection is designed to evaluate the efficacy of CL-SCS therapy in real-world patients suffering from chronic pain.",[26,27,28],"Pain","Chronic Pain","Neuropathic Pain",[30,31],"Saluda","Spinal Cord Stimulation","RECRUITING","2026-06-22",{"date":35,"type":36},"2026-06-23","ACTUAL",{"date":38,"type":36},"2024-01-30",{"date":40,"type":20},"2027-12-31",{"name":42,"class":43},"Saint Francis Hospital","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":44},"100609478","a-prospective-evaluation-of-spinal-cord-induced-muscle-stimulation-musclescs-for-the-treatment-of-chronic-low-back-pain-100609478","NCT07215104","A Prospective Evaluation of Spinal Cord Induced Muscle Stimulation (MuscleSCS) for the Treatment of Chronic Low Back Pain","MuscleSCS","Inclusion Criteria:\n\n1. Patients with PSPS type 1 and 2\n2. Patients with predominant back pain\n3. Patient must be willing and able to provide written informed consent before any clinical investigation-related procedure\n4. Age ≥18 y\n5. Patients with SCS(BurstDR) stimulation in situ for more than 6 month and \\>50% pain relief. Patients have to be satisfied with their existing SCS therapy and predominantly use a BurstDR stimulation program.\n\n   (Only responders to that therapy should be included, not patients who have not responded to their therapy so far.) \\[GROUP 1\\]\n6. Low back pain baseline score of ≥6 on NRS before spinal cord stimulation therapy and a MCID (Minimal clinically important difference) of \\>50% with SCS(BurstDRTM) trial stimulation. \\[GROUP 2\\]\n7. Willing and able to comply with the instructions for use, operate the study device, and comply with this clinical investigation plan\n\nExclusion Criteria:\n\n1. Pathology seen on imaging tests obtained within the past 12 month that is clearly identified and is likely the cause of the CLBP, that can be addressed with surgery\n2. Primary symptom of leg pain, or leg pain is greater than back pain\n3. Back pain is due to any of the following: vascular causes (eg, aortic aneurysm), spinal infection (eg, osteomyelitis), inflammation or damage to the spinal cord (eg, arachnoiditis or syringomyelia), tumor or spinal metastases\n4. Has widespread pain (eg, fibromyalgia) or pain in other area(s), not intended to be treated in this study (eg, neck pain, shoulder pain)\n5. Patient has used a morphine equivalent daily dose of \\>50 MME in the last 30 days\n6. Patients with regular intake of systemic steroids (except inhaled steroids used to treat asthma)\n7. Imaging (MRI, CT, x-ray) findings within the last 12 mon that contraindicate lead placement\n8. Known allergic reaction to implanted materials\n9. Severe scoliotic deformity (\\>11◦ in thoracic or lumbar spine)\n10. Patient has a history of or existing intrathecal drug pump\n11. Patient with other existing implantable electrical devices, i.e. pacemakers, bladder stimulators, etc.\n12. Patient has previous experience with neuromodulation devices, including a failed trial\n13. BMI \\>40\n14. Patient is enrolled, or intends to participate, in another clinical drug and\u002For device study or registry that may interfere with the results of this study.\n15. Presence of other anatomic or comorbid conditions, or other medical, social, or psychologic conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation results\n16. Failed psychologic evaluation\n17. Suspicion or evidence of untreated mental illness, substance abuse, or drug-seeking behavior\n18. Patient is in current litigation for back pain\u002Finjury, or is currently receiving worker's compensation\n19. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.",{"count":53,"type":20},30,[23],"This study is a prospective, multi-center study designed to compare the safety and efficacy of spinal cord induced muscle stimulation (MuscleSCS) for the treatment of chronic low back pain.",[57],"Chronic Low Back Pain (CLBP)","2025-10-08",{"date":60,"type":36},"2025-10-10",{"date":62,"type":36},"2025-10-07",{"date":64,"type":20},"2027-01-01",{"name":42,"class":43},""]