{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,24]],"date-time":"2026-10-24T00:35:37Z","timestamp":1792802137936,"version":"4.5.0"},"reference-count":22,"publisher":"American Medical Association (AMA)","issue":"9","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Neurol"],"published-print":{"date-parts":[[2024,9,1]]},"abstract":"Importance<\/jats:title>Unilateral magnetic resonance\u2013guided focused ultrasound ablation of ventralis intermedius nucleus of the thalamus for essential tremor reduces tremor on 1 side, but untreated contralateral or midline symptoms remain limiting for some patients. Historically, bilateral lesioning produced unacceptable risks and was supplanted by deep brain stimulation; increasing acceptance of unilateral focused ultrasound lesioning has led to interest in a bilateral option.<\/jats:p><\/jats:sec>Objective<\/jats:title>To evaluate the safety and efficacy of staged, bilateral focused ultrasound thalamotomy.<\/jats:p><\/jats:sec>Design, Setting, and Participants<\/jats:title>This prospective, open-label, multicenter trial treated patients with essential tremor from July 2020 to October 2021, with a 12-month follow-up, at 7 US academic medical centers. Of 62 enrolled patients who had undergone unilateral focused ultrasound thalamotomy at least 9 months prior to enrollment, 11 were excluded and 51 were treated. Eligibility criteria included patient age (22 years and older), medication refractory, tremor severity (Clinical Rating Scale for Tremor [CRST] part A score \u22652 for postural or kinetic tremor), and functional disability (CRST part C score \u22652 in any category).<\/jats:p><\/jats:sec>Intervention<\/jats:title>A focused ultrasound system interfaced with magnetic resonance imaging allowed real-time alignment of thermography maps with anatomy. Subthreshold sonications allowed target interrogation for efficacy and off-target effects before creating an ablation.<\/jats:p><\/jats:sec>Main Outcomes and Measures<\/jats:title>Tremor\/motor score (CRST parts A and B) at 3 months for the treated side after treatment was the primary outcome measure, and secondary assessments for efficacy and safety continued to 12 months.<\/jats:p><\/jats:sec>Results<\/jats:title>The mean (SD) population age was 73 (13.9) years, and 44 participants (86.3%) were male. The mean (SD) tremor\/motor score improved from 17.4 (5.4; 95% CI, 15.9-18.9) to 6.4 (5.3; 95% CI, 4.9 to 7.9) at 3 months (66% improvement in CRST parts A and B scores; 95% CI, 59.8-72.2; P<\/jats:italic>\u2009&amp;lt;\u2009.001). There was significant improvement in mean (SD) postural tremor (from 2.5 [0.8]; 95% CI, 2.3 to 2.7 to 0.6 [0.9]; 95% CI, 0.3 to 0.8; P<\/jats:italic>\u2009&amp;lt;\u2009.001) and mean (SD) disability score (from 10.3 [4.7]; 95% CI, 9.0-11.6 to 2.2 [2.8]; 95% CI, 1.4-2.9; P<\/jats:italic>\u2009&amp;lt;\u2009.001). Twelve participants developed mild (study-defined) ataxia, which persisted in 6 participants at 12 months. Adverse events (159 of 188 [85%] mild, 25 of 188 [13%] moderate, and 1 severe urinary tract infection) reported most commonly included numbness\/tingling (n\u2009=\u200917 total; n\u2009=\u20098 at 12 months), dysarthria (n\u2009=\u200915 total; n\u2009=\u20097 at 12 months), ataxia (n\u2009=\u200912 total; n\u2009=\u20096 at 12 months), unsteadiness\/imbalance (n\u2009=\u200910 total; n\u2009=\u20090 at 12 months), and taste disturbance (n\u2009=\u20097 total; n\u2009=\u20093 at 12 months). Speech difficulty, including phonation, articulation, and dysphagia, were generally mild (rated as not clinically significant, no participants with worsening in all 3 measures) and transient.<\/jats:p><\/jats:sec>Conclusions and Relevance<\/jats:title>Staged, bilateral focused ultrasound thalamotomy significantly reduced tremor severity and functional disability scores. Adverse events for speech, swallowing, and ataxia were mostly mild and transient.<\/jats:p><\/jats:sec>Trial Registration<\/jats:title>ClinicalTrials.gov Identifier NCT04112381<\/jats:ext-link>.<\/jats:p><\/jats:sec>","DOI":"10.1001\/jamaneurol.2024.2295","type":"journal-article","created":{"date-parts":[[2024,7,29]],"date-time":"2024-07-29T15:51:15Z","timestamp":1722268275000},"page":"939","source":"Crossref","is-referenced-by-count":72,"title":["Safety and Efficacy of Staged, Bilateral Focused Ultrasound Thalamotomy in Essential Tremor"],"prefix":"10.1001","volume":"81","author":[{"given":"Michael G.","family":"Kaplitt","sequence":"first","affiliation":[{"name":"Department of Neurological Surgery, Weill Cornell Medicine, New York, New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vibhor","family":"Krishna","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery, University of North Carolina, Chapel Hill"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Howard M.","family":"Eisenberg","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery, University of Maryland, Baltimore"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"W. 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