[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100579254":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":28,"studyPopulation":20,"armGroups":29,"interventions":41,"overallOfficials":50,"centralContacts":55,"locations":64,"responsibleParty":79,"collaborators":20,"id":81,"slug":20,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":82,"sex":88,"minAge":89,"maxAge":20,"enrollmentInfo":90,"targetDuration":20,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":99,"overallStatus":66,"whyStopped":20,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Maria Sklodowska-Curie National Research Institute of Oncology","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":20},[9],{"measure":10,"description":11,"timeFrame":12},"Treatment Efficacy","Efficacy of radiosurgery treatment in patients with essential tremor assessed on a dedicated tremor severity scale - Fahn-Tolosa-Marin (FTM)","24 months",[14,17],{"measure":15,"description":16,"timeFrame":12},"Quality of life","The impact of treatment on the quality of life of patients based on the dedicated Quality of Life in Essential Tremor questionnaire",{"measure":18,"description":19,"timeFrame":12},"Safety","Safety and possible complications of radiosurgery assesed in Common Terminology Criteria for Adverse Events (CTCAE) v5.0",null,{"allocation":22,"interventionModel":23,"interventionModelDescription":24,"primaryPurpose":25,"observationalModel":20,"timePerspective":20,"maskingInfo":26},"RANDOMIZED","PARALLEL","Randomised, open label, interventional research experiment","TREATMENT",{"masking":27,"maskingDescription":20,"whoMasked":20},"NONE","The study will include patients diagnosed with essential tremor who have insufficient tremor control despite the use of available pharmacotherapy methods. The study will include patients who have been disqualified from the Deeply Brain Stimulation procedure or who do not consent to its performance. Additional conditions for the examination are age over 50 and the duration of the disease over 5 years.\n\nAfter qualifying and giving written informed consent, the patient will be randomly assigned to one of two study arms:\n\n1. control arm: patients irradiated with the CyberKnife with a dose of 130 Gy\n2. test arm: patients irradiated with the CyberKnife with a dose of 80 Gy\n\nThe primary aim of the study is to determine the effectiveness of radiosurgery in patients with essential tremor. Secondary objectives will be to determine the impact of treatment on the quality of life of, as well as to assess the safety and possible complications of radiosurgery.",[30,36],{"label":31,"type":32,"description":33,"interventionNames":34},"A","ACTIVE_COMPARATOR","Patients irradiated with the CyberKnife with a dose of 130 Gy",[35],"Radiation: Stereotactic Radiosurgery",{"label":37,"type":38,"description":39,"interventionNames":40},"B","EXPERIMENTAL","Patients irradiated with the CyberKnife with a dose of 80 Gy",[35],[42,47],{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":20},"RADIATION","Stereotactic Radiosurgery","Frameless Stereotactic Radiosurgery- CyberKnife with a dose of 80 Gy",[37],{"type":43,"name":44,"description":48,"armGroupLabels":49,"otherNames":20},"Frameless Stereotactic Radiosurgery- CyberKnife with a dose of 130 Gy",[31],[51],{"name":52,"affiliation":53,"role":54},"Aleksandra Napieralska","Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch","PRINCIPAL_INVESTIGATOR",[56,60],{"name":52,"role":57,"phone":58,"phoneExt":20,"email":59},"CONTACT","48322788056","aleksandra.napieralska@gliwice.nio.gov.pl",{"name":61,"role":57,"phone":62,"phoneExt":20,"email":63},"Agnieszka Szczyrba","48322788001","agnieszka.szczyrba@gliwice.nio.gov.pl",[65],{"facility":53,"status":66,"city":67,"state":20,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"RECRUITING","Gliwice","44-101","Poland","PL",{"type":72,"coordinates":73},"Point",[74,75],18.67658,50.29761,{"lat":75,"lon":74},[78],{"name":52,"role":57,"phone":58,"phoneExt":20,"email":59},{"type":80,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100579254",false,"NCT06821906","Stereotactic Radiosurgery in the Treatment of Essential Tremor","Stereotactic Radiosurgery in the Treatment of Tremor in Patients with Essential Tremor - a Randomized Phase II Study","EASIER","Inclusion Criteria:\n\n* Essential tremor diagnosed, Parkinson's disease and other causes of tremor excluded.\n* Insufficient tremor control despite the use of available pharmacotherapy methods.\n* Disqualification from the Deeply Brain Stimualtion procedure\u002Flack of consent to perform it on the side qualified for Stereotactic Radiosurgery\n* Consent to participate in a clinical trial.\n\nExclusion Criteria:\n\n* Age under 50\n* Pregnancy\n* Duration of the disease less than 5 years\n* Dementia, psychosis or other condition that prevents giving informed consent to participate in the study\n* Poor general condition, serious comorbidities\n* Structural changes in the basal ganglia or major atrophic changes\n* Previous radiotherapy to the brain covering the potential treatment area\n* Medical contraindications to magnetic resonance imaging","ALL","50 Years",{"count":91,"type":92},42,"ESTIMATED","INTERVENTIONAL",[95],"PHASE2","The goal of this interventional study is to evaluate the effectiveness of treatment using stereotactic radiosurgery in the treatment of essential tremor in adult patients",[98],"Essential Tremor",[100,101,102,103,104],"tremor","stereotactic radiosurgery","frameless radiosurgery","essenstial tremor","CyberKnife","2025-02-06",{"date":107,"type":108},"2025-02-12","ACTUAL",{"date":110,"type":108},"2024-12-16",{"date":112,"type":92},"2030-05",{"name":5,"class":6},1]