[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100569729":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":17,"centralContacts":23,"locations":30,"responsibleParty":45,"collaborators":17,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":49,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":17,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":17,"overallStatus":68,"whyStopped":17,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Assistance Publique Hopitaux De Marseille","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"VIM radiosurgery with RebrAIn targeting technique","EXPERIMENTAL","VIM radiosurgery with RebrAIn targeting technique (model VIM-RS-LAT-1.0)",[13],"Other: VIM Targeting",{"label":15,"type":16,"description":15,"interventionNames":17},"VIM radiosurgery standard targeting technique","NO_INTERVENTION",null,[19],{"type":6,"name":20,"description":21,"armGroupLabels":22,"otherNames":17},"VIM Targeting","Targeting with the use of VIMRS-LAT-1.0",[9],[24],{"name":25,"role":26,"phone":27,"phoneExt":28,"email":29},"Jean REGIS","CONTACT","0491387059","33","jean.regis@ap-hm.fr",[31],{"facility":32,"status":17,"city":33,"state":17,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Assistance Publique Hopitaux de Marseille","Marseille","13354","France","FR",{"type":38,"coordinates":39},"Point",[40,41],5.38107,43.29695,{"lat":41,"lon":40},[44],{"name":25,"role":26,"phone":27,"phoneExt":28,"email":29},{"type":46,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR","100569729","optimizing-vim-targeting-for-radiosurgery-in-severe-tremor-100569729",false,"NCT06698029","Optimizing VIM Targeting for Radiosurgery in Severe Tremor","Optimisation du Ciblage du VIM Pour la Radiochirurgie Dans le Tremblement sévère","OptiRS","Inclusion Criteria:\n\n* Advanced, disabling, drug-resistant essential tremor\n* Patient selected as part of the multidisciplinary concertation meeting on abnormal movements\n* Patient aged 18 to 85\n* Brain MRI showing no anatomical abnormality contraindicating radiosurgical procedure\n* MATTIS ≥ 130\n* Subject affiliated to or benefiting from a social security scheme\n* Free, informed and written consent signed by the participant and the investigator (no later than the day of inclusion and before any examination required by the research).\n\nExclusion Criteria:\n\n* Patients with a contraindication to brain MRI (pacemaker, intracerebral metal object, etc.)\n* Pregnant or breast-feeding women","ALL","18 Years","85 Years",{"count":59,"type":60},40,"ESTIMATED","INTERVENTIONAL",[63],"NA","Essential tremor is a common neurological disease, the most severe form of which combines postural and intention tremor, with significant physical, psychological and social repercussions. It is in these most severe forms that surgical lesioning of the ventro-intermediate nucleus of the thalamus (VIM) has been proposed. The VIM and its region of interest are almost impossible to identify directly on imaging (especially MRI), as it is part of the thalamus, which has the same intensity. To identify it, teams use average coordinates from stereotactic atlases (imprecise due to the high inter-individual variability of brain anatomy) or retrospective series of implanted patients. The hypothesis of the present trial is that the VIM-RS-LAT-1.0 algorithm developed by RebrAIn for radiosurgery will enable targeting that is at least as effective as conventional targeting. This is a single-center, controlled study, the primary endpoint of which will be assessed at one year, in a blinded, phase 3, comparative, non-inferiority, randomized study in two parallel groups of patients with severe tremor undergoing radiosurgery. In the control group, VIM will be targeted conventionally, and in the experimental group, VIM will be targeted by the RebrAIn algorithm (VIM-RS-LAT-1.0 model) of radiosurgery.",[66,67],"Tremor","Laser Therapy","NOT_YET_RECRUITING","2024-11-18",{"date":71,"type":72},"2024-11-20","ACTUAL",{"date":74,"type":60},"2025-01-01",{"date":76,"type":60},"2027-12-31",{"name":5,"class":6},1]