[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Brai²n\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":76},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,51],{"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":50},"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",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":60,"conditions":61,"keywords":64,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":50},"100624753","neurophysiological-effects-of-medication-tapering-during-treatment-with-spinal-cord-stimulation-100624753","NCT07413731","Neurophysiological Effects of Medication Tapering During Treatment With Spinal Cord Stimulation","Assessment of Neurophysiological Effects of Medication Tapering During Treatment With ECAP Controlled Closed-loop Spinal Cord Stimulation Trial Periods","Inclusion Criteria:\n\n* Patient deemed a suitable candidate for SCS and routinely scheduled to undergo a trial phase with the Evoke SCS system.\n* Diagnosis of Persistent Spinal Pain Syndrome Type 2 (lower spine).\n* Current medication use:\n* No strong opioids or anticonvulsants, or other analgesics\n* Monotherapy with a strong opioid, or\n* Monotherapy with an anticonvulsant.\n* Willing and able to provide written informed consent to participate, based on a voluntary agreement after a full explanation of the study.\n* Age ≥ 18 years at the time of enrollment.\n* Willing and able to comply with study requirements, procedures, and follow-up visits.\n\nExclusion Criteria:\n\n* Evidence of an active disruptive psychological or psychiatric disorder, or other condition significant enough to impact pain perception, compliance with intervention, or ability to evaluate outcomes (as determined by the investigator in consultation with a clinical psychologist).\n* Current diagnosis of a progressive neurological disease such as multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, rapidly progressive diabetic peripheral neuropathy, brain or spinal cord tumor, or severe\u002Fcritical spinal stenosis.\n* Current diagnosis or condition such as coagulation disorder, bleeding diathesis, platelet dysfunction, progressive peripheral vascular disease, or uncontrolled diabetes mellitus that presents excess risk for the procedure (as determined by the investigator).\n* Active systemic or local infection.\n* Pregnancy.\n* Within 6 months prior to enrollment: significant untreated addiction to dependency-producing medications or a history of substance abuse (including alcohol or illicit drugs).",{"count":59,"type":21},50,"This study is being conducted in patients who will receive a spinal cord stimulator. This device helps manage chronic neuropathic pain in the trunk and\u002For limbs. The patients will receive a spinal cord stimulator that is available, notified, and reimbursed in Belgium, which uses a special technology automatically adjusting the intensity of the stimulation. This is called a closed-loop system.\n\nThe closed-loop system stimulates the Beta fibers in the spinal cord and simultaneously measures their response. Based on the measured response, the stimulation strength is automatically adjusted. In Belgium, after implant of the leads the effect must first be evalauted for 3 weeks before implanting the Internal Pulse Generator; this is called the trial period. Only if the trial is successful, the patients will receive a permanent implant.\n\nThe primary goal of the study is to evaluate how different types of pain medication influence the neurophysiological response of the Beta fibers during spinal cord stimulation. Patients will be divided into three groups, based on the medication they are taking before receiving a spinal cord stimulator:\n\n* patients not taking any pain medication,\n* patients taking strong opioids,\n* patients taking anticonvulsant medication.\n\nAs part of the study, patients will follow the normal clinical schedule. During visits, they will be asked questions about their pain, sleep, medication use, and activity. The study will end one month after the patient receives the permanent spinal cord stimulator implant.",[62,63,28],"Persistent Spinal Pain Syndrome Type 2 (PSPS-T2), Lower Spine","Spinal Cord Sensitivity to Neurostimulation",[30,31,32,33,65,66,67,35],"Pain medication tapering","Opioids","Anticonvulsants","2026-02-13",{"date":70,"type":42},"2026-02-17",{"date":72,"type":42},"2025-02-03",{"date":74,"type":21},"2027-04-03",{"name":48,"class":49},""]