[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100516952":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":32,"centralContacts":37,"locations":44,"responsibleParty":59,"collaborators":61,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":10,"enrollmentInfo":74,"targetDuration":10,"studyType":77,"phases":10,"briefSummary":78,"conditions":79,"keywords":82,"overallStatus":84,"whyStopped":10,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Phase 1: development of the questionnaire",null,"development of the patient reported outcome: The strategy consists of four phases:\n\n1. structured litterature review\n2. Group of experts: identification of the main areas to be covered by the questionnaire in order to draw up the focus group moderation guide\n3. focus groups: A discussion session will explore patient symptomatology, the functional impact of the disease, quality of life and the problems faced by patients from their point of view.",[13],"Other: focus groups",{"label":15,"type":10,"description":16,"interventionNames":17},"Phase 2: pilot phase","Once the initial version of the self-questionnaire has been developed, it will be tested on a group of 40 patients with either Chiari malformation with syringomyelia (n = 20), isolated Chiari malformation (n = 10) or isolated syringomyelia (n = 10), managed by the CRMR C-MAVEM at Bicêtre Hospital.",[18],"Other: questionnaire",{"label":20,"type":10,"description":21,"interventionNames":22},"Phase 3: national testing of the questionnaire","the 3rd phase will be submitted to the Human Subjects Protection Review Board according to the progression of the first two phases.",[18],[24,28],{"type":6,"name":25,"description":26,"armGroupLabels":27,"otherNames":10},"focus groups","A dozen patients with Chiari malformation and syringomyelia (n = 4) or isolated Chiari malformation (n = 4) or isolated syringomyelia (n = 4) will be brought together in at least two focus groups. Each focus group will include 5 to 8 patients and will last approximately 1 to 2 hours. The focus groups will be recorded (audio only, no personal data will be collected during these sessions) and will be conducted in the presence of a neurosurgeon and a psychologist, who will moderate the session.",[9],{"type":6,"name":29,"description":30,"armGroupLabels":31,"otherNames":10},"questionnaire","developed questionnaire will be proposed to the patients in phase 2 and 3",[15,20],[33],{"name":34,"affiliation":35,"role":36},"Steven KNAFO","Assistance Publique - Hôpitaux de Paris, Hôpital Bicêtre","PRINCIPAL_INVESTIGATOR",[38],{"name":39,"role":40,"phone":41,"phoneExt":42,"email":43},"Steven KNAFO, MD","CONTACT","01 45 21 22 88","+33","steven.knafo@aphp.fr",[45],{"facility":46,"status":10,"city":47,"state":10,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Hôpital Bicêtre - Service de Neurochirurgie - CRMR C-MAVEM","Le Kremlin-Bicêtre","94270","France","FR",{"type":52,"coordinates":53},"Point",[54,55],2.36073,48.81471,{"lat":55,"lon":54},[58],{"name":34,"role":40,"phone":41,"phoneExt":42,"email":43},{"type":60,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[62],{"name":63,"class":64},"Institut National de la Santé Et de la Recherche Médicale, France","OTHER_GOV","100516952","development-of-a-patient-reported-outcome-measure-for-chiari-malformation-and-syringomyelia-100516952",false,"NCT06011226","Development of a Patient-reported Outcome Measure for Chiari Malformation and Syringomyelia","BCS-score","Inclusion Criteria:\n\nCriteria common to all subjects included in the study\n\n* Age \\> 18 years\n* Subject understanding French Patients included in Phase I\n* Subject with signed informed consent Patients included in phase II\n* Patient not opposed to study participation\n\nPatients Chiari only group:\n\n* Isolated descent of cerebellar tonsils \\> 5 mm below McRae's line (no associated syringomyelia)\n\nPatients syringomyelia only group:\n\n* Presence of an intramedullary fluid cavity secondary to circulatory disturbance of cerebrospinal fluid of non foraminal origin (no Chiari)\n\nPatients Chiari with Syringomyelia group:\n\n* Presence of Chiari malformation (tonsils \\> 5 mm below McRae's line) AND foraminal syringomyelia.\n\nExclusion Criteria:\n\n* Insufficient command of French\n* Minor or protected adult (guardianship, curatorship, safeguard of justice)\n* Diagnosis of Chiari and\u002For syringomyelia not proven by an MRI scan\n* Pregnant or breast-feeding","ALL","18 Years",{"count":75,"type":76},60,"ESTIMATED","OBSERVATIONAL","Chiari malformation corresponds to the herniation of cerebellar tonsils into the foramen magnum resulting in obstruction of cerebrospinal fluid circulation, which may eventually lead to the formation of an intramedullary cavity called syringomyelia.\n\nChiari and syringomyelia can be responsible of variable symptoms, based on which neurosurgeons might propose surgical treatment. Yet, there is no properly developped and validated patient reported outcome measure (PROM) to assess the clinical severity of Chiari malformation and\u002For syringomyelia. The lack of such evaluation tool is a major issue to determine the optimal therapeutic strategy and to achieve a standardized and reproducible follow-up.",[80,81],"Syringomyelia","Chiari Malformation",[80,81,83],"patient-reported outcome measure","NOT_YET_RECRUITING","2023-09-18",{"date":87,"type":88},"2023-09-21","ACTUAL",{"date":90,"type":76},"2023-09",{"date":92,"type":76},"2026-12",{"name":5,"class":6},1]