PMID- 35932269 OWN - NLM STAT- MEDLINE DCOM- 20230404 LR - 20240313 IS - 1933-0693 (Electronic) IS - 0022-3085 (Print) IS - 0022-3085 (Linking) VI - 138 IP - 4 DP - 2023 Apr 1 TI - Magnetic resonance imaging-guided focused ultrasound thalamotomy for essential tremor: 5-year follow-up results. PG - 1028-1033 LID - 10.3171/2022.6.JNS212483 [doi] LID - 2022.6.JNS212483 AB - OBJECTIVE: The objective of this study was to evaluate, at 4 and 5 years posttreatment, the long-term safety and efficacy of unilateral MRI-guided focused ultrasound (MRgFUS) thalamotomy for medication-refractory essential tremor in a cohort of patients from a prospective, controlled, multicenter clinical trial. METHODS: Outcomes per the Clinical Rating Scale for Tremor (CRST), including postural tremor scores (CRST Part A), combined hand tremor/motor scores (CRST Parts A and B), and functional disability scores (CRST Part C), were measured by a qualified neurologist. The Quality of Life in Essential Tremor Questionnaire (QUEST) was used to assess quality of life. CRST and QUEST scores at 48 and 60 months post-MRgFUS were compared to those at baseline to assess treatment efficacy and durability. All adverse events (AEs) were reported. RESULTS: Forty-five and 40 patients completed the 4- and 5-year follow-ups, respectively. CRST scores for postural tremor (Part A) for the treated hand remained significantly improved by 73.3% and 73.1% from baseline at both 48 and 60 months posttreatment, respectively (both p < 0.0001). Combined hand tremor/motor scores (Parts A and B) also improved by 49.5% and 40.4% (p < 0.0001) at each respective time point. Functional disability scores (Part C) increased slightly over time but remained significantly improved through the 5 years (p < 0.0001). Similarly, QUEST scores remained significantly improved from baseline at year 4 (p < 0.0001) and year 5 (p < 0.0003). All previously reported AEs remained mild or moderate, and no new AEs were reported. CONCLUSIONS: Unilateral MRgFUS thalamotomy demonstrates sustained and significant tremor improvement at 5 years with an overall improvement in quality-of-life measures and without any progressive or delayed complications. Clinical trial registration no.: NCT01827904 (ClinicalTrials.gov). FAU - Cosgrove, G Rees AU - Cosgrove GR AD - Departments of1Neurosurgery. FAU - Lipsman, Nir AU - Lipsman N AD - Departments of2Neurosurgery and. FAU - Lozano, Andres M AU - Lozano AM AD - 3Department of Neurosurgery, Toronto Western Hospital, University of Toronto, Ontario, Canada. FAU - Chang, Jin Woo AU - Chang JW AD - 4Department of Neurosurgery, Yonsei University College of Medicine, Seoul, Korea. FAU - Halpern, Casey AU - Halpern C AD - Departments of5Neurosurgery. FAU - Ghanouni, Pejman AU - Ghanouni P AD - 6Radiology, Stanford University School of Medicine, Stanford, California. FAU - Eisenberg, Howard AU - Eisenberg H AD - Departments of7Neurosurgery and. FAU - Fishman, Paul AU - Fishman P AD - 8Neurology, University of Maryland School of Medicine, Baltimore, Maryland. FAU - Taira, Takaomi AU - Taira T AD - 9Department of Neurosurgery, Tokyo Women's Medical University, Tokyo, Japan. FAU - Schwartz, Michael L AU - Schwartz ML AD - Departments of2Neurosurgery and. FAU - McDannold, Nathan AU - McDannold N AD - 10Radiology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts. FAU - Hayes, Michael AU - Hayes M AD - 11Neurology, and. FAU - Ro, Susie AU - Ro S AD - 12Neurology, Swedish Neuroscience Center, Seattle, Washington; and. FAU - Shah, Binit AU - Shah B AD - 13Neurology, University of Virginia School of Medicine, Charlottesville, Virginia. FAU - Gwinn, Ryder AU - Gwinn R AD - Departments of14Neurosurgery and. FAU - Santini, Veronica E AU - Santini VE AD - 15Neurology, and. FAU - Hynynen, Kullervo AU - Hynynen K AD - 16Radiology, Sunnybrook Health Sciences Centre, University of Toronto, Ontario, Canada. FAU - Elias, W Jeff AU - Elias WJ AD - Departments of17Neurological Surgery and. LA - eng SI - ClinicalTrials.gov/NCT01827904 GR - UL1 TR001863/TR/NCATS NIH HHS/United States PT - Journal Article PT - Multicenter Study DEP - 20220805 PL - United States TA - J Neurosurg JT - Journal of neurosurgery JID - 0253357 SB - IM CIN - J Neurol. 2023 Nov;270(11):5671-5673. PMID: 37787811 MH - Humans MH - *Essential Tremor/diagnostic imaging/surgery MH - Tremor MH - Follow-Up Studies MH - Prospective Studies MH - Quality of Life MH - Thalamus/diagnostic imaging/surgery MH - Magnetic Resonance Imaging/methods MH - Treatment Outcome PMC - PMC10193464 OTO - NOTNLM OT - MRI OT - essential tremor OT - focused ultrasound OT - functional neurosurgery OT - thalamotomy COIS- Drs. Cosgrove, Ghanouni, Eisenberg, and Santini received clinical or research support from InSightec for the study described. Dr. Lozano is a consultant for Medtronic, Abbott, Boston Scientific, and Insightec and the scientific director for Functional Neuromodulation. Dr. Ghanouni is a consultant for InSightec and SonALASense. Dr. Taira is a consultant for and receives honoraria from InSightec Japan. Dr. Santini receives support from Biogen and Genentech for non-study-related clinical or research effort and receives honoraria from the American Academy of Neurology and International Parkinson and Movement Disorder Society. Dr. Hynynen receives royalties from InSightec. Dr. Elias is a consultant for InSightec. EDAT- 2022/08/07 06:00 MHDA- 2023/04/04 06:42 PMCR- 2022/08/05 CRDT- 2022/08/06 10:02 PHST- 2021/11/14 00:00 [received] PHST- 2022/06/15 00:00 [accepted] PHST- 2023/04/04 06:42 [medline] PHST- 2022/08/07 06:00 [pubmed] PHST- 2022/08/06 10:02 [entrez] PHST- 2022/08/05 00:00 [pmc-release] AID - 2022.6.JNS212483 [pii] AID - 10.3171/2022.6.JNS212483 [doi] PST - epublish SO - J Neurosurg. 2022 Aug 5;138(4):1028-1033. doi: 10.3171/2022.6.JNS212483. Print 2023 Apr 1.