[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100493713":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":38,"responsibleParty":55,"collaborators":25,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":61,"acronym":25,"eligibilityCriteria":62,"healthyVolunteers":59,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":25,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":76,"overallStatus":41,"whyStopped":25,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Universitaire Ziekenhuizen KU Leuven","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients with CPSP which is pharmacorefractory and have a good analgesic response to M1-rTMS","EXPERIMENTAL","Diagnosed with definite CPSP (Treede-Klit criteria), which is pharmacorefractory (i.e. amitriptyline 75mg\u002Fd 4w, lamotrigine 200mg\u002Fd 8w and pregabalin 600mg\u002Fd resulting in \\\u003C50% VAS reduction and\u002For intolerable side-effects).\n\nA good analgesic response to M1-rTMS is defined as: ≥50% mean 10-d VAS reduction immediately following vs. before active M1-rTMS minus mean 10-d VAS reduction immediately following vs. pre sham M1-rTMS. A good analgesic response gives a high positive predictive value for pain reduction by MCS.",[13],"Device: MCS surgery for CPSP",{"label":15,"type":10,"description":16,"interventionNames":17},"Patients with CPSP which is pharmacorefractory with less analgesic M1-rTMS response","Diagnosed with definite CPSP (Treede-Klit criteria), which is pharmacorefractory (i.e. amitriptyline 75mg\u002Fd 4w, lamotrigine 200mg\u002Fd 8w and pregabalin 600mg\u002Fd resulting in \\\u003C50% VAS reduction and\u002For intolerable side-effects).\n\nPatients with less analgesic M1-rTMS response (n≈20) will be 1:1 randomized to either MCS (≈10) or Vc-DBS (n≈10).",[13,18],"Device: Vc-DBS surgery for CPSP",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","MCS surgery for CPSP","The investigational devices that will be used for the MCS surgeries are the following: the Vanta with AdaptiveStim Technology Primary cell neurostimulator or the Intellis Implantable Neurostimulator with AdaptiveStim Technology from Medtronic, Inc. (MN, USA). These implantable neurostimulators are intended to generate electrical pulses and to deliver stimulation trough one or more leads as part of a neurostimulation system for pain therapy in adults.",[9,15],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Vc-DBS surgery for CPSP","For the deep brain stimulation procedure, we will use Vercise stimulators from Boston Scientific together with the Cartesia Directional Leads or the Percept PC stimulator from Medtronic.",[15],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Philippe De Vloo, prof. dr.","CONTACT","016 344290","neurochirurgie@uzleuven.be",{"name":37,"role":33,"phone":34,"phoneExt":25,"email":35},"Daan Remans",[39],{"facility":40,"status":41,"city":42,"state":25,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"UZ Leuven","RECRUITING","Leuven","3000","Belgium","BE",{"type":47,"coordinates":48},"Point",[49,50],4.70093,50.87959,{"lat":50,"lon":49},[53],{"name":54,"role":33,"phone":34,"phoneExt":25,"email":35},"Philippe De Vloo, prof.dr.",{"type":56,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100493713","neuromodulation-for-central-post-stroke-pain-mechanism-safety-and-outcome-100493713",false,"NCT05708729","Neuromodulation for Central Post-stroke Pain: Mechanism, Safety and Outcome","Inclusion Criteria:\n\n1. Able to provide voluntary written informed consent of the participant prior to any screening procedures\n2. Male or female patients\n3. Aged 18-70 years\n4. Diagnosed with definite CPSP (Treede-Klit criteria) (1, 9), which is pharmacorefractory (i.e. amitriptyline 75mg\u002Fd 4w, lamotrigine 200mg\u002Fd 8w and pregabalin 600mg\u002Fd resulting in \\\u003C50% VAS reduction and\u002For intolerable side-effects)\n\nExclusion Criteria:\n\n1. Aphasia\n2. Pregnancy or intention to become pregnant in the following year\n3. Medical inoperability\n4. Impossibility to temporarily withhold anticoagulation or anti-platelet medication\n5. Impossibility to undergo MRI, fMRI and\u002For PET imaging\n6. Complete destruction of the stimulation target region (M1 or Vc)\n7. Uncontrolled seizures\n8. Expected relocation in the following year.","ALL","18 Years","70 Years",{"count":67,"type":68},32,"ESTIMATED","INTERVENTIONAL",[71],"NA","Central post-stroke pain (CPSP) is an often pharmacorefractory type of neuropathic pain that develops in 8% of stroke patients. CPSP has been treated with three distinct types of neuromodulation (deep brain stimulation of the sensory thalamus (Vc-DBS), motor cortex repetitive transcranial magnetic stimulation (M1-rTMS), and motor cortex stimulation (MCS)), but the level of evidence for these procedures is very low. Moreover, data on the changes in pain brain circuitry in CPSP, and the effect of neuromodulation on this circuitry is very limited.",[74,75],"Central Post-stroke Pain","CPSP",[77,78,79,80],"neuromodulation","DBS","rTMS","MCS","2024-06-28",{"date":83,"type":84},"2024-07-01","ACTUAL",{"date":86,"type":84},"2023-01-24",{"date":88,"type":68},"2026-04",{"name":5,"class":6},1]