3-D Tractography Guided Focused Ultrasound Treatment for Moderate to Severe Essential Tremor

What this Trial Is About

Essential tremor ET is a common neurological disorder that can cause significant functional and psychological difficulties, often resistant to oral medications. Researchers are investigating a new approach called 3-D tractography Vim-Focused Ultrasound Ablation Vim-FUSA, which uses advanced brain imaging to better target the area responsible for tremors. This study aims to compare this new method with the standard Vim-FUSA technique and evaluate its safety, feasibility, and effectiveness in both animal and human studies. The treatment involves using focused ultrasound guided by magnetic resonance MR imaging and 3-D tractography to precisely ablate 70% of the ventral intermediate nucleus Vim in the brain. The procedure includes head preparation, placement of a stereotactic frame, pre-surgery imaging, exploration with low-dose sonications, and therapeutic sonications to deliver the ablation while monitoring tremor and side effects. The study includes an experimental animal phase comparing the new and standard methods and a human phase assessing 24 participants before treatment and three months after. Participants will undergo assessments including videotaped tremor evaluations at baseline and three months post-treatment, with blinded comparison to matched controls. Researchers will use intraoperative MR imaging to distinguish treated tissue from swelling and predict clinical outcomes. Safety, side effects, quality of life related to tremor, and participant satisfaction will also be monitored. Overall participation lasts at least three months, with careful follow-up to evaluate treatment effects and safety.

3-D Tractography FUS Ablation for Essential Tremor