[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100541529":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":46,"studyPopulation":42,"armGroups":47,"interventions":54,"overallOfficials":62,"centralContacts":67,"locations":76,"responsibleParty":97,"collaborators":99,"id":107,"slug":108,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":42,"eligibilityCriteria":113,"healthyVolunteers":109,"sex":114,"minAge":115,"maxAge":42,"enrollmentInfo":116,"targetDuration":42,"studyType":119,"phases":120,"briefSummary":121,"conditions":122,"keywords":42,"overallStatus":79,"whyStopped":42,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},{"fullName":5,"class":6},"University of North Carolina, Chapel Hill","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":20,"otherOutcomes":31},[9,13,17],{"measure":10,"description":11,"timeFrame":12},"Number of Participants without Side Effects","Feasibility is defined as the ability to complete the procedure without side effects.","during the surgical procedure",{"measure":14,"description":15,"timeFrame":16},"Absolute Change in Tremor","The absolute change from baseline to Month 3 follow-up in upper extremity Tremor-Motor scores for the treated side is a sub-scale of Clinical Rating Scale for Tremor (CRST) Part A and Part B sum used to measure treated-side upper extremity tremor changes over time. Tremor-motor scores range from 0-32 points. Individual subject's scores at Baseline and 3 Months used to calculate absolute change from baseline and averaged across subjects. High absolute change from baseline is better (shows improvement).","Baseline, Month 3",{"measure":18,"description":19,"timeFrame":16},"Relative Change in Tremor","The relative change from baseline to Month 3 follow-up in upper extremity Tremor-Motor scores for the treated side is a sub-scale of Clinical Rating Scale for Tremor (CRST) Part A and Part B sum used to measure treated-side upper extremity tremor changes over time. Tremor-motor scores range from 0-32 points. Individual subject's scores at Baseline and 3 Months used to calculate relative change from baseline and averaged across subjects. High relative change from baseline is better (shows improvement).",[21,25,28],{"measure":22,"description":23,"timeFrame":24},"Number of Participants with Procedure-Related Side Effects","Prevalence and severity of procedure-related side effects measured by the following: ataxia (SARA), speech disturbance (VHI), sensory loss (SWME), muscle weakness (MRC)","3 months after the surgical procedure",{"measure":26,"description":27,"timeFrame":24},"Relative Change in Tremor-Related Quality of Life","The Quality of Life Essential Tremor Questionnaire (QUEST) will be used to assess tremor-related quality of life. QUEST has scores ranging from 0 to 100 with higher scores indicating worse disability.",{"measure":29,"description":30,"timeFrame":24},"Number of Participants Who Are Satisfied with Treatment","Measured using a single question asking about patient satisfaction ranging from 1 to 5 with higher scores indicating higher satisfaction.",[32,36],{"measure":33,"description":34,"timeFrame":35},"Change in Tremor Based on Video Assessment","Upper extremity tremors will be measured by video recording using i-Phone set-up.","Baseline, during the surgical procedure",{"measure":37,"description":38,"timeFrame":35},"Change in Gait Based on Video Assessment","Gait will be measured by video recording using i-Phone set-up.",{"allocation":40,"interventionModel":41,"interventionModelDescription":42,"primaryPurpose":43,"observationalModel":42,"timePerspective":42,"maskingInfo":44},"NA","SINGLE_GROUP",null,"TREATMENT",{"masking":45,"maskingDescription":42,"whoMasked":42},"NONE","Essential tremor (ET) is a common neurological disorder and a leading cause of functional and psychological disabilities that can be difficult to suppress with oral medications, many of which have considerable side effects limiting adequate dosing. As a result, up to 20% of ET patients cannot achieve satisfactory control of their symptoms and must consider interventional options. Focused ultrasound ablation (FUSA) of the ventral intermediate nucleus (Vim) is an FDA-approved and Medicare-reimbursed procedure for ET resistant to medications that can selectively ablate the brain area associated with tremor without the need for surgical incisions or anesthesia. The success of Vim-FUSA depends on the ability to accurately ablate 70% of the Vim volume without lesioning neighboring structures, a goal that is complicated by technical challenges in three critical phases of the procedure: planning (identifying the Vim location and extension); delivery (ablating the Vim volume with adequate accuracy); and monitoring (confirming Vim ablation with reliable intraoperative imaging). The investigators propose to advance Vim-FUSA 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. Aim 1. Estimate and characterize the improvement in Vim ablation achieved with 3-D tractography Vim-FUSA vs. standard Vim-FUSA in an experimental controlled animal study. Through an experimental animal study, the investigators will characterize the Vim ablation delivered with 3-D tractography Vim-FUSA in one hemisphere (experimental group) vs. standard Vim-FUSA in the opposite hemisphere (control group). Aim 2. Test safety, feasibility, and preliminary efficacy, and estimate effect size of 3-D tractography Vim-FUSA in a phase-II, two-groups, pre-post interventional human study. In a human study, the investigators will test the safety and feasibility of ablating 70% of the Vim volume while checking for side effects with intraoperative clinical testing. Tremor assessments will be videotaped at baseline and 12 weeks and compared, in a blinded fashion, with age-sex matched controls randomly selected from the video repository of the two FDA-regulated studies of standard Vim-FUSA at baseline and 12 weeks. Aim 3 (Exploratory). Assess the accuracy of i-MR in differentiating tissue ablation from immediate perilesional edema and its utility in predicting Vim-FUSA clinical outcomes. In the experimental animal study, the investigators will estimate and compare the accuracy of conventional and non-conventional i-MR in differentiating tissue necrosis from perilesional edema. In the interventional human study, the investigators will evaluate the utility of i-MR in predicting Vim-FUSA clinical outcomes",[48],{"label":49,"type":50,"description":51,"interventionNames":52},"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.",[53],"Device: MR-guided Focused Ultrasound Ablation",[55],{"type":56,"name":57,"description":58,"armGroupLabels":59,"otherNames":60},"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).",[49],[61],"3-D Tractography",[63],{"name":64,"affiliation":65,"role":66},"Vibhor Krishna, MD","University of North Carolina at Chapel Hll","PRINCIPAL_INVESTIGATOR",[68,72],{"name":64,"role":69,"phone":70,"phoneExt":42,"email":71},"CONTACT","+1(919)-445-2410","vibhor_krishna@med.unc.edu",{"name":73,"role":69,"phone":74,"phoneExt":42,"email":75},"Victoria Scott","919-966-0864","Victoria_Scott@med.unc.edu",[77],{"facility":78,"status":79,"city":80,"state":81,"zip":82,"country":83,"countryCode":84,"cosmosGeoPoint":85,"geoPoint":90,"contacts":91},"University of North Carolina at Chapel Hill","RECRUITING","Chapel Hill","North Carolina","27599","United States","US",{"type":86,"coordinates":87},"Point",[88,89],-79.05584,35.9132,{"lat":89,"lon":88},[92,93,96],{"name":73,"role":69,"phone":74,"phoneExt":42,"email":75},{"name":94,"role":69,"phone":95,"phoneExt":42,"email":71},"Vibhor Krishna, MD, SM","919-445-2410",{"name":94,"role":66,"phone":42,"phoneExt":42,"email":42},{"type":98,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR",[100,102,105],{"name":101,"class":6},"University of Pittsburgh",{"name":103,"class":104},"National Institute of Neurological Disorders and Stroke (NINDS)","NIH",{"name":106,"class":6},"University of Missouri-Columbia","100541529","3-d-tractography-fus-ablation-for-essential-tremor-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 essential tremor 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 with inability to temporarily stop any antithrombotic medication\n* Tremor disorders other than ET (e.g., Parkinson disease, traumatic tremor, alcohol or drug dependent tremor that remains after at least 2 weeks of abstinence etc.)\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* Prior brain surgery that could influence the focused ultrasound procedure outcomes, including deep brain stimulation\n* Botulinum toxin injection in the tremor-impacted areas three months prior to the baseline assessment and until 3-months after Vim-FUSA\n* does not qualify for FDA-approved clinical use based on current FDA labeling except that skull density ratio ≤ 0.4 will be allowed for this study\n* Any significant issue raised by the neurologist or neurosurgeon that may compromise participant safety or potentially interfere with study interpretation.\n* non-English speaking","ALL","22 Years",{"count":117,"type":118},24,"ESTIMATED","INTERVENTIONAL",[40],"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.",[123],"Essential Tremor","2026-09-02",{"date":126,"type":127},"2026-09-08","ACTUAL",{"date":129,"type":127},"2024-02-28",{"date":131,"type":118},"2028-02-28",{"name":5,"class":6},1]