Bilateral Focused Ultrasound Thalamotomy for Essential Tremor (BEST‐FUS Phase 2 Trial)

Abstract

A BS TRACT: Background: In patients with medically refractory essential tremor, unilateral magnetic resonanceguided focused ultrasound thalamotomy can improve contralateral tremor. However, this procedure does not address ipsilateral symptoms. Objective: The objective of the current study was to determine whether bilateral thalamotomies can be performed with an acceptable safety profile where benefits outweigh adverse effects. Methods: We conducted a prospective, single-arm, single-blinded phase 2 trial of second-side magnetic resonance-guided focused ultrasound thalamotomy in patients with essential tremor. Patients were followed for 3 months. The primary outcome was the change in quality of life relative to baseline, as well as the answer to the question "Given what you know now, would you treat the second side again?". Secondary outcomes included tremor, gait, speech, and adverse effects. Results: Ten patients were analyzed. The study met both primary outcomes, with the intervention resulting in clinically significant improvement in quality of life at 3 months (mean Quality of Life in Essential Tremor score difference, 19.7; 95%CI,; P = 0.004) and all patients reporting that they would elect to receive the secondside treatment again. Tremor significantly improved in all patients. Seven experienced mild adverse effects, including 2 with transient gait impairment and a fall, 1 with dysarthria and dysphagia, and 1 with mild dysphagia persisting at 3 months.

Milestones in Tremor Research: 10 Years Later

“…Safety profile is satisfactory and the absence of craniectomy and general anesthesia makes elderly patients suitable candidates 75 . More recently, staged bilateral MRgFUS thalamotomy has been shown to be both effective and safe in ET patients 76 …”

Unilateral Transcranial Magnetic Resonance-guided Focused Ultrasound Pallidothalamic Tractotomy in X-linked Dystonia-parkinsonism: A Case Report

“…However, a staged procedure has been done in patients with essential tremor and PD. [21][22][23] At 1-year follow up, bilateral pallidal DBS on XDP has shown improvement in the dystonia (n=16, 18-100%) with one patient worsening (-7%) and improvement in the parkinsonism (n=14, 6-81%) and three patients worsening (-[29-100%]). 6,7,24 Longer follow-up (29-84 months) still showed improvement compared to baseline, albeit at a lower degree (n=13, 3-98%) and 1 patient worsening (-20%).…”

Advances in Immunotherapy for the Treatment of Adult Glioblastoma: Overcoming Chemical and Physical Barriers

“…Thermal ablative ultrasound therapy uses high-intensity focused ultrasound to increase the local temperature to 60 °C or higher to induce coagulative necrosis. It has been safely used in the brain to ablate neuronal tracks underlying the pathogenesis of essential tremor [ 189 , 190 , 191 ] and also to treat chronic neuropathic pain [ 192 ]. Preclinical evidence has indicated that ultrasound thermal ablation may work adjunctively with immune checkpoint inhibitors [ 193 , 194 ].…”