[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100301599":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":59,"centralContacts":64,"locations":70,"responsibleParty":90,"collaborators":32,"id":93,"slug":94,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":32,"eligibilityCriteria":99,"healthyVolunteers":95,"sex":100,"minAge":101,"maxAge":102,"enrollmentInfo":103,"targetDuration":32,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":113,"overallStatus":73,"whyStopped":32,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"University Hospital Tuebingen","OTHER",[8,20,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Mutation carrier","EXPERIMENTAL","The participants will be tested genetically if they carry a disease causing mutation or not. Depending on their genetic test result they will at the end of the study divided into two groups. The clinician will be blinded throughout the entire study to the genetic results.",[13,14,15,16,17,18,19],"Other: SPRS Score and clinical signs","Behavioral: Cognition Testing using CANTAB","Diagnostic Test: Lumbar Puncture and blood draw","Diagnostic Test: MRI","Diagnostic Test: Electrophysiology","Diagnostic Test: Testing functional performance","Diagnostic Test: Non motor symptoms",{"label":21,"type":10,"description":11,"interventionNames":22},"Non-mutation carrier",[13,14,15,16,17,18,19],{"label":24,"type":10,"description":25,"interventionNames":26},"Known-mutation carriers but presymptomatic","In a third arm (open arm) we will also include positive predictive tested participants which know that they are carrying a known mutation but are at inclusion into the study asymptomatic (according to the inclusion \u002F exclusion criteria).",[13,14,15,16,17,18,19],[28,33,38,43,47,51,55],{"type":6,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"SPRS Score and clinical signs","Patients will clinically characterized by using the SPRS Score and the inventory V3",[24,9,21],null,{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":32},"BEHAVIORAL","Cognition Testing using CANTAB","Patients will be tested using the CANTAB",[24,9,21],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":32},"DIAGNOSTIC_TEST","Lumbar Puncture and blood draw","Biomaterial will be collected (not obligate) to compare e.g. Nfl levels in serum and CSF",[24,9,21],{"type":39,"name":44,"description":45,"armGroupLabels":46,"otherNames":32},"MRI","MRI will be used to reveal presymptomatic brain morphology changes (not obligate)",[24,9,21],{"type":39,"name":48,"description":49,"armGroupLabels":50,"otherNames":32},"Electrophysiology","Electrophysiological tests will be used to characterize patients better.",[24,9,21],{"type":39,"name":52,"description":53,"armGroupLabels":54,"otherNames":32},"Testing functional performance","By using the 3 minute walk, 5 stair-climb test, and 10m walking test we will try to identify and measure subclinical progression prior to disease onset",[24,9,21],{"type":39,"name":56,"description":57,"armGroupLabels":58,"otherNames":32},"Non motor symptoms","By using a number of different tests we try to identify other non-motor symptoms which might manifest prior to disease onset.",[24,9,21],[60],{"name":61,"affiliation":62,"role":63},"Ludger Schöls, Prof.","Head of Department","PRINCIPAL_INVESTIGATOR",[65],{"name":61,"role":66,"phone":67,"phoneExt":68,"email":69},"CONTACT","+49 7071 \u002F 29","82057","ludger.schoels@uni-tuebingen.de",[71],{"facility":72,"status":73,"city":74,"state":32,"zip":75,"country":76,"countryCode":77,"cosmosGeoPoint":78,"geoPoint":83,"contacts":84},"University Hospital Tübingen, Center for Neurology","RECRUITING","Tübingen","72076","Germany","DE",{"type":79,"coordinates":80},"Point",[81,82],9.05222,48.52266,{"lat":82,"lon":81},[85,88],{"name":86,"role":66,"phone":87,"phoneExt":32,"email":69},"Ludger Schöls, MD","+49 7071 29 82057",{"name":89,"role":63,"phone":32,"phoneExt":32,"email":32},"Tim W. Rattay, MD",{"type":63,"investigatorFullName":91,"investigatorTitle":92,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Prof. Dr. Ludger Schöls","Prinicipal Investigator","100301599","the-prespg4-study---studying-the-prodromal-and-early-phase-of-spg4-100301599",false,"NCT03206190","The preSPG4 Study - Studying the Prodromal and Early Phase of SPG4","Studying the Prodromal and Early Phase of Hereditary Spastic Paraplegia Type 4 (SPG4)","Inclusion Criteria:\n\n* First degree relatives (parents, offspring, and sibs) of SPG4 patients or symptomatic individuals with known SPAST mutation\n* Age 18 to 70 years\n* Written, informed consent (patient)\n\nExclusion Criteria:\n\n* No known SPAST-mutation within the family\n* Manifest spastic gait (subclinical signs like increased deep tendon reflexes, positive Babinski sign are allowed)\n* Participation in interventional trials","ALL","18 Years","70 Years",{"count":104,"type":105},200,"ESTIMATED","INTERVENTIONAL",[108],"NA","Study goals\n\n1. Prospective longitudinal data on progression in the natural course of SPG4 in presymptomatic mutation carriers prior to clinical disease onset and in early stages of disease\n2. Biomarkers providing objective measures of disease activity",[111,112],"Hereditary Spastic Paraplegia","Hereditary, Spastic Paraplegia, Autosomal Dominant",[114,115,116,117,118,119],"SPG4","presymptomatic","at risk","mutation carriers","biomarkers","longitudinal progression","2022-08-18",{"date":122,"type":123},"2022-08-23","ACTUAL",{"date":125,"type":123},"2018-07-01",{"date":127,"type":105},"2031-12",{"name":5,"class":6},1]