[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100420735":3},{"organization":4,"outcomesModule":7,"designInfo":54,"detailedDescription":11,"studyPopulation":11,"armGroups":60,"interventions":66,"overallOfficials":72,"centralContacts":76,"locations":82,"responsibleParty":103,"collaborators":105,"id":109,"slug":110,"hasResults":111,"nctId":112,"briefTitle":113,"officialTitle":113,"acronym":11,"eligibilityCriteria":114,"healthyVolunteers":111,"sex":115,"minAge":116,"maxAge":117,"enrollmentInfo":118,"targetDuration":11,"studyType":121,"phases":122,"briefSummary":123,"conditions":124,"keywords":126,"overallStatus":85,"whyStopped":11,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":137},{"fullName":5,"class":6},"Northwell Health","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":44,"otherOutcomes":11},[9,13,15,17,18,20,21,23,24,26,27,29,31,34,35,36,37,39,41,43],{"measure":10,"description":11,"timeFrame":12},"Structural connectivity as indicated by fractional anisotropy (FA) as measured by diffusion tensor imaging (DTI) MRI",null,"Baseline before DBS implant",{"measure":10,"description":11,"timeFrame":14},"24 months after start of DBS",{"measure":16,"description":11,"timeFrame":12},"Structural connectivity as indicated by mean diffusivity as measured by diffusion tensor imaging (DTI) MRI",{"measure":16,"description":11,"timeFrame":14},{"measure":19,"description":11,"timeFrame":12},"Structural connectivity as indicated by radial diffusivity as measured by diffusion tensor imaging (DTI) MRI",{"measure":19,"description":11,"timeFrame":14},{"measure":22,"description":11,"timeFrame":12},"Structural connectivity as indicated by axial diffusivity as measured by diffusion tensor imaging (DTI) MRI",{"measure":22,"description":11,"timeFrame":14},{"measure":25,"description":11,"timeFrame":12},"Functional connectivity as indicated by blood oxygen level dependent (BOLD) signal as measured by resting state functional MRI (rsfMRI)",{"measure":25,"description":11,"timeFrame":14},{"measure":25,"description":11,"timeFrame":28},"Baseline before DBS is turned off",{"measure":25,"description":11,"timeFrame":30},"72 hours after DBS is turned off",{"measure":32,"description":33,"timeFrame":12},"Tremor as assessed by score on The Essential Tremor Rating Scale (TETRAS)","10 items are measured-each is scored from 0-4,higher number indicating more tremor",{"measure":32,"description":33,"timeFrame":14},{"measure":32,"description":33,"timeFrame":28},{"measure":32,"description":33,"timeFrame":30},{"measure":32,"description":33,"timeFrame":38},"During DBS placement surgery before active DBS",{"measure":32,"description":33,"timeFrame":40},"During DBS placement surgery during active DBS",{"measure":42,"description":11,"timeFrame":38},"Spectral power recorded during intraoperative electrocorticography (ECoG)",{"measure":42,"description":11,"timeFrame":40},[45,48,49,50,51,53],{"measure":46,"description":47,"timeFrame":12},"Ataxia as assessed by score on the Scale for the Assessment and Rating of Ataxia (SARA)","It has eight categories with accumulative score ranging from 0 (no ataxia) to 40 (most severe ataxia).",{"measure":46,"description":47,"timeFrame":14},{"measure":46,"description":47,"timeFrame":28},{"measure":46,"description":47,"timeFrame":30},{"measure":52,"description":11,"timeFrame":28},"Tremor amplitude as assessed by accelerometric power",{"measure":52,"description":11,"timeFrame":30},{"allocation":55,"interventionModel":56,"interventionModelDescription":11,"primaryPurpose":57,"observationalModel":11,"timePerspective":11,"maskingInfo":58},"NA","SINGLE_GROUP","BASIC_SCIENCE",{"masking":59,"maskingDescription":11,"whoMasked":11},"NONE",[61],{"label":62,"type":63,"description":11,"interventionNames":64},"Deep Brain Stimulation(DBS)","EXPERIMENTAL",[65],"Device: Deep Brain Stimulation",[67],{"type":68,"name":69,"description":70,"armGroupLabels":71,"otherNames":11},"DEVICE","Deep Brain Stimulation","Medtronic Activa device will be implanted and administered clinically, except as part of the trial after 24 months of DBS being on it will be turned off for 3 days and will be turned back on.",[62],[73],{"name":74,"affiliation":5,"role":75},"Albert J Fenoy, MD","PRINCIPAL_INVESTIGATOR",[77],{"name":78,"role":79,"phone":80,"phoneExt":11,"email":81},"Mark Amandola","CONTACT","516 491 1054","mamandola@northwell.edu",[83],{"facility":84,"status":85,"city":86,"state":87,"zip":88,"country":89,"countryCode":90,"cosmosGeoPoint":91,"geoPoint":96,"contacts":97},"North Shore University Hospital","RECRUITING","Manhasset","New York","11030","United States","US",{"type":92,"coordinates":93},"Point",[94,95],-73.69957,40.79788,{"lat":95,"lon":94},[98,100],{"name":99,"role":79,"phone":11,"phoneExt":11,"email":11},"Albert Fenoy",{"name":101,"role":102,"phone":11,"phoneExt":11,"email":11},"Prashin Unadkat","SUB_INVESTIGATOR",{"type":104,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[106],{"name":107,"class":108},"National Institutes of Health (NIH)","NIH","100420735","elucidating-the-temporality-of-structural-and-functional-connectivity-changes-in-essential-tremor-after-successful-deep-brain-stimulation-to-the-dentato-rubro-thalamic-tract-100420735",false,"NCT04758624","Elucidating the Temporality of Structural and Functional Connectivity Changes in Essential Tremor After Successful Deep Brain Stimulation to the Dentato-rubro-thalamic Tract","Inclusion Criteria:\n\n* the diagnosis of Essential Tremor, made by a movement disorder neurologist, where tremor is not secondary to any disease process or traumatic insult\n* distal appendicular tremor, with minimal proximal component\n* tremor refractory to multiple medication regimens and\u002For where the medications cause intolerable side effects\n* tremor judged to be severely impacting their quality of life.\n\nExclusion Criteria:\n\n* significant neurological disorder\n* significant dementia or neurocognitive limitations as assessed by neuropsychiatry (when necessary)\n* severe psychiatric illness with suicidal ideations\n* previous surgery to destroy the target region of the brain\n* surgical contraindications to DBS\n* current major medical problems that affect brain anatomy,neurochemistry, or function, e.g., liver insufficiency, kidney insufficiency, cardiovascular problems, systemic infections, cancer, hypothyroidism, auto-immune diseases, and any current of history of brain disorder (seizure disorder, stroke, dementia, meningitis, encephalitis, degenerative neurologic diseases and head injury with loss of consciousness for any period of time)\n* family history of hereditary neurologic disorder, besides essential tremors ET\n* floating metallic objects in the body\n* pregnancy\n* alcohol or substance abuse\u002Fdependence in the past 6 months.","ALL","18 Years","85 Years",{"count":119,"type":120},72,"ESTIMATED","INTERVENTIONAL",[55],"The purpose of this study is to elucidate the structural connectivity of the dentato-rubro-thalamic tract (DRTt) and to detect functional network changes due to DRTt stimulation",[125],"Essential Tremor",[127],"deep brain stimulation","2026-09-28",{"date":130,"type":131},"2026-09-29","ACTUAL",{"date":133,"type":131},"2021-12-04",{"date":135,"type":120},"2027-08-31",{"name":5,"class":6},1]