[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100541529":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":37,"responsibleParty":57,"collaborators":59,"id":67,"slug":31,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":31,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":31,"enrollmentInfo":75,"targetDuration":31,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":31,"overallStatus":40,"whyStopped":31,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"University of North Carolina, Chapel Hill","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"3-D Tractography Vim FUSA","EXPERIMENTAL","Twenty-four consecutive essential tremor (ET) participants undergoing Vim FUSA using 3-D tractography will be assessed at baseline and Month 3.",[13],"Device: MR-guided Focused Ultrasound Ablation",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","MR-guided Focused Ultrasound Ablation","3-D tractography Vim-FUSA -D tractography Vim-FUSA will be carried out as follows: (a) head shaving and placement of the stereotactic frame (Integra radionics frame, Integra Lifesciences, NJ, USA) secured to the skull with transcutaneous screws; (b) positioning on the procedure table and placement of the ultrasound transducer; (c) acquisition of conventional magnetic resonance (MR) imaging and co-registration with the CT head and 3-D tractography imaging acquired pre-surgically; (d) exploration of the target area with subtherapeutic sonications; (e) intraoperative monitoring with clinical testing of tremor and side effects with a standardized protocol. (f) Therapeutic sonications in the target area to deliver definitive ablation followed by clinical testing of tremor and side effects with a standardized protocol as described in section (e).",[9],[21],"3-D Tractography",[23],{"name":24,"affiliation":25,"role":26},"Vibhor Krishna, MD","University of North Carolina at Chapel Hll","PRINCIPAL_INVESTIGATOR",[28,33],{"name":24,"role":29,"phone":30,"phoneExt":31,"email":32},"CONTACT","+1(919)-445-2410",null,"vibhor_krishna@med.unc.edu",{"name":34,"role":29,"phone":35,"phoneExt":31,"email":36},"Victoria Scott","919-966-0864","Victoria_Scott@med.unc.edu",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"University of North Carolina at Chapel Hill","RECRUITING","Chapel Hill","North Carolina","27599","United States",{"type":46,"coordinates":47},"Point",[48,49],-79.05584,35.9132,{"lat":49,"lon":48},[52,53,56],{"name":34,"role":29,"phone":35,"phoneExt":31,"email":36},{"name":54,"role":29,"phone":55,"phoneExt":31,"email":32},"Vibhor Krishna, MD, SM","919-445-2410",{"name":54,"role":26,"phone":31,"phoneExt":31,"email":31},{"type":58,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[60,62,64],{"name":61,"class":6},"Texas Tech University Health Sciences Center, El Paso",{"name":63,"class":6},"University of Pittsburgh",{"name":65,"class":66},"National Institute of Neurological Disorders and Stroke (NINDS)","NIH","100541529",false,"NCT06331052","3-D Tractography FUS Ablation for Essential Tremor","3-D Tractography Focused Ultrasound Ablation for Essential Tremor","Inclusion Criteria:\n\n* Diagnosis of moderate to severe ET agreed upon by at least two movement disorder trained physicians\n* Symptoms refractory to at least two medications\n* Stable medication regimen for at least 4 weeks prior to screening\n* Willing and able to participate in all follow-up visits\n* Willing and able to undergo MR imaging.\n\nExclusion Criteria:\n\n* Uncontrolled hypertension\n* Medically unstable coronary artery disease\n* Coagulopathy, anticoagulant therapy, or inability to temporarily stop any antithrombotic medication\n* Tremor disorders other than ET\n* Unwilling or unable to undergo tremor surgery while awake\n* Significant and non-correctible motion artifact in imaging\n* Pregnant at the time of enrollment or preoperative evaluation\n* Dementia\n* History of psychosis\n* History of drug or alcohol abuse\n* Prior brain surgery such as Vim-FUSA, deep brain stimulation, and gamma knife thalamotomy\n* Botulinum toxin injection in the tremor-impacted areas three months prior to the baseline assessment and until 3-months after Vim-FUSA\n* Skull density ratio lower than 0.4\n* Does not qualify for FDA-approved clinical use based on current FDA labeling\n* Any significant issue raised by the neurologist or neurosurgeon that may compromise participant safety or potentially interfere with study interpretation.","ALL","22 Years",{"count":76,"type":77},24,"ESTIMATED","INTERVENTIONAL",[80],"NA","The investigators propose to advance Vim-FUSA (Ventral Intermediate Nucleus - Focused Ultrasound Ablation) with the support of 3-D tractography, a neuroimaging technique to visually represent nerve tracts within the brain. The investigators hypothesize that 3-D tractography Vim-FUSA will improve the Vim ablation compared to standard Vim-FUSA and prove safe and feasible in the clinical setting. The investigators also hypothesize that intraoperative magnetic resonance (i-MR) monitoring will differentiate ablated tissue from immediate perilesional edema and accurately predict the Vim-FUSA clinical outcomes.",[83],"Essential Tremor","2026-01-15",{"date":86,"type":87},"2026-01-20","ACTUAL",{"date":89,"type":87},"2024-02-28",{"date":91,"type":77},"2028-02-28",{"name":5,"class":6},1]