[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100558073":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":44,"collaborators":48,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":54,"sex":60,"minAge":61,"maxAge":20,"enrollmentInfo":62,"targetDuration":20,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":20,"overallStatus":30,"whyStopped":20,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Erasmus Medical Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Spinal cord stimulation","EXPERIMENTAL","Patients are all included in this experimental arm, where they receive all four stimulation options consecutively, but in different orders. After receiving all four stimulation options, the patients are allowed to choose which stimulation option of the four they want to have for the following period.",[13],"Device: Spinal cord stimulator",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Spinal cord stimulator","Electrical stimulation of the dorsal horn to reduce chronic pain.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Mathilde Scholtes, MSc","CONTACT","+31650032165","m.m.a.scholtes@erasmusmc.nl",[28],{"facility":29,"status":30,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Erasmus Medical Centre","RECRUITING","Rotterdam","South Holland","3015GD","Netherlands","NL",{"type":37,"coordinates":38},"Point",[39,40],4.47917,51.9225,{"lat":40,"lon":39},[43],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},{"type":45,"investigatorFullName":46,"investigatorTitle":47,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Prof. Dr. Frank Huygen","Head of Centre for Pain Medicine",[49],{"name":50,"class":51},"Boston Scientific Corporation","INDUSTRY","100558073","spinal-cord-stimulation-for-intractable-mononeuropathy-100558073",false,"NCT06546371","Spinal Cord Stimulation for Intractable Mononeuropathy","Spinal Cord Stimulation for Intractable Mononeuropathy: a Pilot Study","SCIMONO","Inclusion Criteria:\n\n* Suffering from painful intractable peripheral mononeuropathy in the distal extremities, preferably post-traumatic or post-surgical, confirmed by electromyography (EMG)\n* Symptoms refractory to conventional medical management for at least 6 months according to treating physician\n* 18 years or older\n* Pain score on numeric rating scale (NRS) of at least 5 (average pain intensity in week prior to assessment)\n* Stable or absent concomitant analgesics\n\nExclusion Criteria:\n\n* Mononeuropathy located in the head or torso\n* Mononeuropathy by avulsion at the plexus brachialis\n* Life expectancy \\\u003C1 year\n* Anticoagulant drug therapy or disturbed coagulation\n* Immune-compromised patients\n* Pregnancy\n* Lack of cooperation of the patient or patient has a history of noncompliance with regard to (a) medical regime(s)\n* Patients with psychological factors or addiction that require treatment","ALL","18 Years",{"count":63,"type":64},12,"ESTIMATED","INTERVENTIONAL",[67],"NA","Rationale: For patients with mononeuropathy, literature has shown that spinal cord stimulation (SCS) is an effective therapy for patients who are therapy-resistant to more conventional treatments. However, there is a strong need for higher quality evidence to determine the place of this therapy in this target group. Before conducting a large randomized controlled trial (RCT) we propose to conduct an explorative pilot study based on which an effect size estimation and power calculation for a larger study can be done. We will assess the effects of SCS in patients with mononeuropathy measured according to the \"Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials\" (IMMPACT) guidelines, and assess the stimulation paradigm preferences in these patients.\n\nObjective: To perform an explorative pilot study based on which an effect size estimation and power calculation for an efficacy trial can be done.\n\nStudy design: Mono-center explorative pilot study in 12 patients with intractable peripheral mononeuropathic pain who receive a spinal cord stimulator at the Erasmus Medical Centre.\n\nStudy population: 12 patients suffering from intractable peripheral mononeuropathic pain.\n\nIntervention: Participants who receive a spinal cord stimulator must fill in IMMPACT guideline questionnaires and undergo several measurement procedures after receiving SCS implantation. The effect of various SCS paradigms on the chronic mononeuropathic pain is assessed at 3 and 6 months.\n\nMain study parameters\u002Fendpoints: Effect of 6 months of individually optimized SCS in patients with mononeuropathy according to the IMMPACT guidelines.",[70,71],"Mononeuropathies","Spinal Cord Stimulation","2025-02-27",{"date":74,"type":75},"2025-03-03","ACTUAL",{"date":77,"type":75},"2024-05-13",{"date":79,"type":64},"2025-05",{"name":5,"class":6},1]