[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575688":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":13,"centralContacts":17,"locations":23,"responsibleParty":39,"collaborators":7,"id":42,"slug":7,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":43,"sex":49,"minAge":50,"maxAge":7,"enrollmentInfo":51,"targetDuration":7,"studyType":54,"phases":7,"briefSummary":55,"conditions":56,"keywords":7,"overallStatus":25,"whyStopped":7,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},{"fullName":5,"class":6},"AZ Delta","OTHER",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"DEVICE","ECAP-controlled, closed-loop SCS","Spinal cord stimulation that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude",[14],{"name":15,"affiliation":5,"role":16},"Karel Hanssens","PRINCIPAL_INVESTIGATOR",[18],{"name":19,"role":20,"phone":21,"phoneExt":7,"email":22},"Karel Hanssens, Dr.","CONTACT","0032 51 23 69 12","ctc.pijn@azdelta.be",[24],{"facility":5,"status":25,"city":26,"state":7,"zip":27,"country":28,"cosmosGeoPoint":29,"geoPoint":34,"contacts":35},"RECRUITING","Roeselare","8800","Belgium",{"type":30,"coordinates":31},"Point",[32,33],3.12269,50.94653,{"lat":33,"lon":32},[36,38],{"name":37,"role":20,"phone":21,"phoneExt":7,"email":22},"AZ Delta Hanssens",{"name":15,"role":20,"phone":7,"phoneExt":7,"email":7},{"type":40,"investigatorFullName":15,"investigatorTitle":41,"investigatorAffiliation":5,"oldNameTitle":7,"oldOrganization":7},"SPONSOR_INVESTIGATOR","MD","100575688",false,"NCT06775535","Neuronal Activation Accuracy in Closed-loop Spinal Cord Stimulation","Assessment of Neuronal Activation Accuracy and Stimulation Sensation in Patients with Closed-loop Spinal Cord Stimulation (CL-SCS) Therapy","NAA","Inclusion Criteria:\n\n* Subject is deemed a suitable candidate for SCS trial and permanent implant and has been routinely scheduled to undergo an SCS trial phase with the Evoke SCS System.\n* Subject has a minimum of pain intensity of 5\u002F10 on the numeric rating scale (NRS) at baseline\n* Subject is ≥ 18 years old.\n* Subject is not pregnant or nursing.\n* Subject is willing and capable of giving informed consent.\n\nExclusion Criteria:\n\n* Subject currently has an active implantable device including pacemakers, spinal cord stimulator or intrathecal drug delivery system.\n* Subject is incapable of understanding or responding to the study questionnaires.\n* Subject is incapable of understanding or operating the patient programmer handset.","ALL","18 Years",{"count":52,"type":53},12,"ESTIMATED","OBSERVATIONAL","Observational, prospective, single-center to assess neuronal activation accuracy and stimulation sensation in patients with closed-loop spinal cord stimulation therapy.",[57,58,59],"Chronic Pain","Neuropathic Pain","Persistent Spinal Pain Syndrome Type 2","2025-01-09",{"date":62,"type":63},"2025-01-15","ACTUAL",{"date":65,"type":63},"2023-08-02",{"date":67,"type":53},"2029-12",{"name":15,"class":6},1]