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3-D Tractography FUS Ablation for Essential Tremor

RecruitingNAAges 22 Years - anyAllUniversity of North Carolina, Chapel Hill
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Diagnosis of moderate to severe ET agreed upon by at least two movement disorder trained physicians * Symptoms refractory to at least two medications * Stable essential tremor medication regimen for at least 4 weeks prior to screening * Willing and able to participate in all follow-up visits * Willing and able to undergo MR imaging. Exclusion Criteria: * Uncontrolled hypertension * Medically unstable coronary artery disease * Coagulopathy with inability to temporarily stop any antithrombotic medication * 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.) * Unwilling or unable to undergo tremor surgery while awake * Significant and non-correctible motion artifact in imaging * Pregnant at the time of enrollment or preoperative evaluation * Dementia * History of psychosis * Prior brain surgery that could influence the focused ultrasound procedure outcomes, including deep brain stimulation * Botulinum toxin injection in the tremor-impacted areas three months prior to the baseline assessment and until 3-months after Vim-FUSA * does not qualify for FDA-approved clinical use based on current FDA labeling except that skull density ratio โ‰ค 0.4 will be allowed for this study * Any significant issue raised by the neurologist or neurosurgeon that may compromise participant safety or potentially interfere with study interpretation. * non-English speaking
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What it tests

  • MR-guided Focused Ultrasound Ablation
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Where

1 site
University of North Carolina at Chapel Hill
Chapel Hill, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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