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3-D Tractography FUS Ablation for Essential Tremor

Sponsor: University of North Carolina, Chapel Hill • ClinicalTrials.gov ID: NCT06331052

Registry updated: 2026-09-08

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Description

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.

Interventions

MR-guided Focused Ultrasound Ablation (Device)
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).

Eligibility criteria

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 ≤ 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

Conditions

Essential Tremor

Locations

University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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