[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648891":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":11,"centralContacts":26,"locations":36,"responsibleParty":61,"collaborators":11,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":11,"enrollmentInfo":75,"targetDuration":11,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":39,"whyStopped":11,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Universitair Ziekenhuis Brussel","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Refill at home","ACTIVE_COMPARATOR",null,[13],"Procedure: Refill at home",{"label":15,"type":10,"description":11,"interventionNames":16},"Refill at the hospital",[17],"Procedure: Refill at the hospital",[19,23],{"type":20,"name":15,"description":21,"armGroupLabels":22,"otherNames":11},"PROCEDURE","Intrathecal pump refill procedure conducted at the hospital",[15],{"type":20,"name":9,"description":24,"armGroupLabels":25,"otherNames":11},"Intrathecal pump refill procedure conducted at the home of the patient",[9],[27,32],{"name":28,"role":29,"phone":30,"phoneExt":11,"email":31},"Maarten Moens, MD PhD","CONTACT","+3224775514","stimulusresearchgroup@gmail.com",{"name":33,"role":29,"phone":34,"phoneExt":11,"email":35},"Lisa Goudman, PhD","+32472412507","lisa.goudman@vub.be",[37],{"facility":38,"status":39,"city":40,"state":11,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"UZ Brussel","RECRUITING","Jette","1090","Belgium","BE",{"type":45,"coordinates":46},"Point",[47,48],4.33419,50.87309,{"lat":48,"lon":47},[51,52,55,57,59],{"name":28,"role":29,"phone":11,"phoneExt":11,"email":11},{"name":53,"role":54,"phone":11,"phoneExt":11,"email":11},"Ulrike Van Hoey, MSc","SUB_INVESTIGATOR",{"name":56,"role":54,"phone":11,"phoneExt":11,"email":11},"Britt Winnepenninckx, MSc",{"name":58,"role":54,"phone":11,"phoneExt":11,"email":11},"Koen Putman, MSc, PhD",{"name":60,"role":54,"phone":11,"phoneExt":11,"email":11},"Lisa Goudman, MSc, PhD",{"type":62,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Moens Maarten","principal investigator","100648891","intrathecal-pump-refills-at-home-or-at-the-hospital-100648891",false,"NCT07727798","Intrathecal Pump Refills at Home or at the Hospital","Intrathecal Pump Refills at Home or at the Hospital: a Randomized Controlled Crossover Trial","IMPROVE","Inclusion Criteria:\n\n* Actively receiving Intrathecal drug delivery\n* Stable medication dosage for at least 3 months\n* Dutch, French or English speaking adults\n\nExclusion Criteria:\n\n* Life expectancy \\\u003C 6 months\n* Patients planned for but not yet received Intrathecal drug delivery implant\n* No residence in Belgium","ALL","18 Years",{"count":76,"type":77},82,"ESTIMATED","INTERVENTIONAL",[80],"NA","The IMPROVE study is a randomized, controlled, cross-over trial designed to compare intrathecal pump refills performed at home with those carried out in the hospital. Intrathecal drug delivery (IDD) is used in patients with chronic pain or severe spasticity. Use of IDD requires the performance of pump refills about 4-6 times a year which may be a burdensome and stressful experience for patients and their caregivers. Hospital visits can increase stress, pain, and caregiver strain, while early pilot studies suggest home-based refills may be both safe and more comfortable.\n\nEighty-two adult patients in Belgium with an implanted intrathecal pump will be enrolled in the IMPROVE study. Each participant will undergo four refill procedures: two at home and two at the hospital, in randomized order.",[83],"Intrathecal Pump Refill",[85,86,87,88,89,90,91,92],"Intrathecal drug delivery","intrathecal pump therapy","neuromodulation","refill","patient comfort","telemedicine","remote care","hospital to home transition","2026-07-21",{"date":95,"type":96},"2026-07-27","ACTUAL",{"date":98,"type":96},"2025-10-15",{"date":100,"type":77},"2028-10-01",{"name":63,"class":6},1]