[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"persistent-spinal-pain-syndrome-type-2-psps-t-lower-spine\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:persistent-spinal-pain-syndrome-type-2-psps-t-lower-spine":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":5},"100631586","evaluation-of-medication-tapering-on-the-sensitivity-of-the-spinal-cord-using-closed-loop-spinal-cord-stimulation-pilot-study-100631586",false,"NCT07502612","Evaluation of Medication Tapering on the Sensitivity of the Spinal Cord Using Closed-Loop Spinal Cord Stimulation (Pilot Study)","Neurophysiological Effects of Pain Medication Reduction During Treatment With Closed-Loop Spinal Cord Stimulation: A Pilot Study","ECAP-MED Pilot","Inclusion Criteria:\n\n* Candidate for SCS and scheduled for trial with Evoke system.\n* Diagnosis of FBSS or FNSS (PSPS-T2).\n* Current use of ≥1 qualifying pain medication at or above minimum daily dose:\n* Gabapentin ≥150 mg\n* Pregabalin ≥75 mg\n* Morphine ≥40 mg\n* Hydromorphone ≥10 mg\n* Oxycodone ≥20 mg\n* Fentanyl ≥25 µg\n* Signed informed consent.\n* Age ≥18 years.\n\nExclusion Criteria:\n\n* Active disruptive psychiatric disorder or condition impacting pain perception or compliance.\n* Progressive neurological disease (MS, CIDP, progressive arachnoiditis, progressive diabetic neuropathy, brain\u002Fspinal tumor, severe spinal stenosis).\n* Coagulation disorder, platelet dysfunction, progressive vascular disease, or uncontrolled diabetes with procedural risk.\n* Active systemic or local infection.\n* Pregnancy.\n* Significant untreated addiction or substance abuse (within 6 months prior)","ALL","18 Years",{"count":20,"type":21},20,"ESTIMATED","6 Months","OBSERVATIONAL","This pilot study investigates the effects of reducing pain medication including opioids and anticonvulsants, on spinal cord sensitivity during closed-loop spinal cord stimulation (SCS). Patients with Persistent Spinal Pain Syndrome Type 2 (FBSS\u002FFNSS) will undergo a standard 21-day SCS trial with the Evoke closed-loop system, followed by permanent implantation if successful. Neurophysiological responses (activation plots, conduction velocity, chronaxie, rheobase) and patient-reported outcomes (VAS, activity, sleep, medication intake) will be collected during the trial and up to 6 months after implantation. The goal is to evaluate the relationship between medication tapering and spinal cord sensitivity",[26,27,28],"Failed Back Surgery Syndrome (FBSS)","Persistent Spinal Pain Syndrome Type 2 (PSPS-T) Lower Spine","Neurophysiological Sensitivity to Spinal Cord Stimulation",[30,31,32,33,34,35,36,37],"Spinal cord stimulation","Closed-loop stimulation","Evoked Compound Action Potentials (ECAPs)","Neurophysiology","Pain medication reduction","Neuromodulation","opioids","anticonvulsants","RECRUITING","2026-03-27",{"date":41,"type":42},"2026-03-31","ACTUAL",{"date":44,"type":42},"2022-06-08",{"date":46,"type":21},"2026-08-28",{"name":48,"class":49},"Brai²n","OTHER"]