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3-D Tractography FUS Ablation for Essential Tremor
3-D Tractography Focused Ultrasound Ablation for Essential Tremor
Who can join
Ages 22 and older · All sexes
Full 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
About the study
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.
What is being tested
- MR-guided Focused Ultrasound Ablation (device)
Sponsor: University of North Carolina, Chapel Hill · Participants: 24 · Started: Feb 28, 2024
Contact the study team
- Vibhor Krishna, MD · Phone: +1(919)-445-2410
- Victoria Scott · Phone: 919-966-0864
Official record on ClinicalTrials.gov — NCT06331052
Locations in the U.S.
| North Carolina | University of North Carolina at Chapel Hill, Chapel Hill |
Conditions
From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.