[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631586":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":24,"locations":30,"responsibleParty":48,"collaborators":10,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":53,"sex":59,"minAge":60,"maxAge":10,"enrollmentInfo":61,"targetDuration":64,"studyType":65,"phases":10,"briefSummary":66,"conditions":67,"keywords":71,"overallStatus":33,"whyStopped":10,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Brai²n","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients with FBSS, taking at least qualifying opioids",null,"Patients with FBSS, taking at least one qualifying pain medication at or above the minimum daily dose.",[13],"Other: Spinal Cord Stimulation with Evoke Closed-Loop System",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":10},"Spinal Cord Stimulation with Evoke Closed-Loop System","All patients undergo a 21-day trial with Evoke closed-loop SCS. If successful, patients receive a permanent implant. Assessments include activation plots, conduction velocity, chronaxie, rheobase, VAS pain, sleep, activity, and medication intake.",[9],[20],{"name":21,"affiliation":22,"role":23},"Tony Van Havenbergh, MD, PhD","Brai²n \u002F Department of Neurosurgery, ZAS Augustinus, Antwerp, Belgium","PRINCIPAL_INVESTIGATOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},"Pieter Van Looy","CONTACT","+32 3 443 48 72","pieter.vanlooy@zas.be",[31],{"facility":32,"status":33,"city":34,"state":10,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Brai²n - ZAS Augustinus","RECRUITING","Wilrijk","2610","Belgium","BE",{"type":39,"coordinates":40},"Point",[41,42],4.39513,51.16734,{"lat":42,"lon":41},[45,46],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},{"name":47,"role":23,"phone":10,"phoneExt":10,"email":10},"Tony Van Havenbergh, MD",{"type":23,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Dr. Tony Van Havenbergh","Chairman, Department of Neurosurgery (NeurochirurgieGroep); Director, Antwerp Skull Base Team; Director, Brai²n","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":62,"type":63},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",[68,69,70],"Failed Back Surgery Syndrome (FBSS)","Persistent Spinal Pain Syndrome Type 2 (PSPS-T) Lower Spine","Neurophysiological Sensitivity to Spinal Cord Stimulation",[72,73,74,75,76,77,78,79],"Spinal cord stimulation","Closed-loop stimulation","Evoked Compound Action Potentials (ECAPs)","Neurophysiology","Pain medication reduction","Neuromodulation","opioids","anticonvulsants","2026-03-27",{"date":82,"type":83},"2026-03-31","ACTUAL",{"date":85,"type":83},"2022-06-08",{"date":87,"type":63},"2026-08-28",{"name":5,"class":6},1]