[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100509247":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":31,"locations":36,"responsibleParty":136,"collaborators":140,"id":143,"slug":144,"hasResults":145,"nctId":146,"briefTitle":147,"officialTitle":147,"acronym":148,"eligibilityCriteria":149,"healthyVolunteers":150,"sex":151,"minAge":10,"maxAge":10,"enrollmentInfo":152,"targetDuration":10,"studyType":155,"phases":10,"briefSummary":156,"conditions":157,"keywords":160,"overallStatus":55,"whyStopped":10,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":174},{"fullName":5,"class":6},"Uppsala University Hospital","OTHER",[8,14,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1 - prodromal iNPH",null,"Individuals with typical imaging findings consistent with iNPH but none or too mild symptoms to motivate shunt surgery.",[13],"Procedure: Shunt surgery",{"label":15,"type":10,"description":16,"interventionNames":10},"Group 2 - Healthy controls","Age matched healthy controls",{"label":18,"type":10,"description":19,"interventionNames":20},"Group 3 - symptomatic iNPH","Patients with symptomatic iNPH",[13],[22],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":10},"PROCEDURE","Shunt surgery","Shunt surgery according to each local centers routine",[9,18],[28],{"name":29,"affiliation":5,"role":30},"Johan Virhammar, MD, PhD","PRINCIPAL_INVESTIGATOR",[32],{"name":29,"role":33,"phone":34,"phoneExt":10,"email":35},"CONTACT","+46186110000","johan.virhammar@neuro.uu.se",[37,53,68,82,97,112,127],{"facility":38,"status":39,"city":40,"state":10,"zip":10,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Kuopio University Hospital","NOT_YET_RECRUITING","Kuopio","Finland","FI",{"type":44,"coordinates":45},"Point",[46,47],27.67703,62.89238,{"lat":47,"lon":46},[50],{"name":51,"role":33,"phone":10,"phoneExt":10,"email":52},"Ville Leinonen, MD, PhD","Ville.Leinonen@kuh.fi",{"facility":54,"status":55,"city":56,"state":10,"zip":10,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"Bellaria Hospital","RECRUITING","Bologna","Italy","IT",{"type":44,"coordinates":60},[61,62],11.33875,44.49381,{"lat":62,"lon":61},[65],{"name":66,"role":33,"phone":10,"phoneExt":10,"email":67},"Giorgio Palandri, MD, PhD","giopalandri@gmail.com",{"facility":69,"status":39,"city":70,"state":10,"zip":10,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Sahlgrenska University Hospital","Gothenburg","Sweden","SE",{"type":44,"coordinates":74},[75,76],11.96679,57.70716,{"lat":76,"lon":75},[79],{"name":80,"role":33,"phone":10,"phoneExt":10,"email":81},"Mats Tullberg, MD, PhD","mats.tullberg@neuro.gu.se",{"facility":83,"status":39,"city":84,"state":10,"zip":10,"country":71,"countryCode":72,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Linköping University Hospital","Linköping",{"type":44,"coordinates":86},[87,88],15.62157,58.41086,{"lat":88,"lon":87},[91,94],{"name":92,"role":33,"phone":10,"phoneExt":10,"email":93},"Fredrik Lundin, MD, PhD","Fredrik.Lundin@regionostergotland.se",{"name":95,"role":33,"phone":10,"phoneExt":10,"email":96},"Katarina Laurell, MD, PhD","katarina.laurell@neuro.uu.se",{"facility":98,"status":39,"city":99,"state":10,"zip":10,"country":71,"countryCode":72,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"Karolinska University Hospital","Stockholm",{"type":44,"coordinates":101},[102,103],18.06871,59.32938,{"lat":103,"lon":102},[106,109],{"name":107,"role":33,"phone":10,"phoneExt":10,"email":108},"Lisa Arvidsson, MD, PhD","lisa.arvidsson@regionstockholm.se",{"name":110,"role":33,"phone":10,"phoneExt":10,"email":111},"Jens Tomner, MD","jens.tomner@regionstockholm.se",{"facility":113,"status":39,"city":114,"state":10,"zip":10,"country":71,"countryCode":72,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"Umeå University Hospital","Umeå",{"type":44,"coordinates":116},[117,118],20.25972,63.82842,{"lat":118,"lon":117},[121,124],{"name":122,"role":33,"phone":10,"phoneExt":10,"email":123},"William Hansson, MD","william.hansson@umu.se",{"name":125,"role":33,"phone":10,"phoneExt":10,"email":126},"Jan Malm, MD, PhD","jan.malm@umu.se",{"facility":5,"status":55,"city":128,"state":10,"zip":10,"country":71,"countryCode":72,"cosmosGeoPoint":129,"geoPoint":133,"contacts":134},"Uppsala",{"type":44,"coordinates":130},[131,132],17.63889,59.85882,{"lat":132,"lon":131},[135],{"name":29,"role":33,"phone":10,"phoneExt":10,"email":35},{"type":137,"investigatorFullName":138,"investigatorTitle":139,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Johan Virhammar","Associate professor",[141],{"name":142,"class":6},"Swedish Society for Medical Research","100509247","european-study-of-prodromal-inph-100509247",false,"NCT05910944","European Study of Prodromal iNPH","STOP iNPH","Inclusion criteria - Group 1 - prodromal iNPH\n\n* Brain imaging with both:\n\n  * Evans index \\> 0.3\n  * Callosal angle ≤ 90 º or:\n  * Disproportionately enlarged subarachnoid space hydrocephalus (DESH) - defined as: enlarged ventricles, dilated sylvian fissures and tight sulci at the high convexity.\n* Absence of symptoms or too mild symptoms to motivate shunt surgery according to local routine, and all of the following:\n\n  * Normal gait pattern, or slight disturbance of the gait pattern that is not considered to be caused by a disease in the central nervous system (CNS).\n  * Gait velocity (maximum gait speed), men ≥ 1.4 m\u002Fs; women ≥ 1.25 m\u002Fs.\n  * Rombergs test with eyes open \\> 60 seconds\n  * Mini Mental State Examination (MMSE) ≥ 27 or Montreal Cognitive Assessment (MoCA) ≥ 23\n* Informed consent\n\nExclusion criteria - Group 1 - prodromal iNPH\n\n* Contraindication for MRI\n* Other serious disease with expected survival less than three years\n* Other type of hydrocephalus:\n\n  * non-communicating hydrocephalus\n  * secondary communicating hydrocephalus\n  * suspected congenital hydrocephalus (severely enlarged ventricles, narrow sylvian fissures and normal non-compressed sulci at the high convexity or morphological findings consistent with PaVM18)\n* Anticoagulants in a dose that hinders lumbar puncture\n\nInclusion criteria - Group 2 - healthy controls\n\n• Age \\> 65 years\n\nExclusion criteria - Group 2 - healthy controls:\n\n* Imaging findings meet inclusion criteria of Group 1\n* Previously known relevant neurological disease\n* Pathological gait pattern with unknown reason.\n* MMSE \\\u003C 27 or MoCA \\\u003C 26.\n* Anticoagulants in a dose that hinders lumbar puncture\n\nInclusion criteria Group 3 symptomatic iNPH\n\n* iNPH diagnosis according to international guidelines.19\n* Age matched with the individual in Group 1 (+\u002F- 3 years)\n\nExclusion criteria Group 3 symptomatic iNPH\n\n* Previous stroke (clinical stroke, not only radiologically verified)\n* Other serious disease with expected survival less than three years",true,"ALL",{"count":153,"type":154},140,"ESTIMATED","OBSERVATIONAL","To investigate if progression from prodromal into symptomatic NPH can be predicted from advanced neuroimaging, biomarkers in cerebrospinal fluid (CSF) and plasma and investigate the unknown mechanisms causing deterioration by investigating longitudinal changes in the above-mentioned variables. Three different cohorts with both asymptomatic and symptomatic patients as well as healthy controls will be investigated over time, both without intervention and before and after shunt surgery.",[158,159],"Normal Pressure Hydrocephalus","Hydrocephalus",[161,162,163,164],"natural history","cerebrospinal fluid","biomarkers","long term follow-up","2026-04-29",{"date":167,"type":168},"2026-04-30","ACTUAL",{"date":170,"type":168},"2023-11-01",{"date":172,"type":154},"2035-12-31",{"name":138,"class":6},7]