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A Randomized Trial of Focused Ultrasound Thalamotomy for Essential Tremor

 W Jeffrey Elias  ;  Nir Lipsman  ;  William G Ondo  ;  Pejman Ghanouni  ;  Young G Kim  ;  Wonhee Lee  ;  Michael Schwartz  ;  Kullervo Hynynen  ;  Andres M Lozano  ;  Binit B Shah  ;  Diane Huss  ;  Robert F Dallapiazza  ;  Ryder Gwinn  ;  Jennifer Witt  ;  Susie Ro  ;  Howard M Eisenberg  ;  Paul S Fishman  ;  Dheeraj Gandhi  ;  Casey H Halpern  ;  Rosalind Chuang  ;  Kim Butts Pauly  ;  Travis S Tierney  ;  Michael T Hayes  ;  G Rees Cosgrove  ;  Toshio Yamaguchi  ;  Keiichi Abe  ;  Takaomi Taira  ;  Jin W Chang 
 NEW ENGLAND JOURNAL OF MEDICINE, Vol.375(8) : 730-739, 2016-08 
Journal Title
Issue Date
Activities of Daily Living ; Aged ; Double-Blind Method ; Essential Tremor / therapy* ; Female ; Humans ; Magnetic Resonance Imaging ; Male ; Middle Aged ; Postoperative Complications ; Quality of Life ; Thalamus / surgery* ; Ultrasonic Therapy* / adverse effects ; Ultrasonic Therapy* / methods ; Ultrasonography, Interventional
Background: Uncontrolled pilot studies have suggested the efficacy of focused ultrasound thalamotomy with magnetic resonance imaging (MRI) guidance for the treatment of essential tremor. Methods: We enrolled patients with moderate-to-severe essential tremor that had not responded to at least two trials of medical therapy and randomly assigned them in a 3:1 ratio to undergo unilateral focused ultrasound thalamotomy or a sham procedure. The Clinical Rating Scale for Tremor and the Quality of Life in Essential Tremor Questionnaire were administered at baseline and at 1, 3, 6, and 12 months. Tremor assessments were videotaped and rated by an independent group of neurologists who were unaware of the treatment assignments. The primary outcome was the between-group difference in the change from baseline to 3 months in hand tremor, rated on a 32-point scale (with higher scores indicating more severe tremor). After 3 months, patients in the sham-procedure group could cross over to active treatment (the open-label extension cohort). Results: Seventy-six patients were included in the analysis. Hand-tremor scores improved more after focused ultrasound thalamotomy (from 18.1 points at baseline to 9.6 at 3 months) than after the sham procedure (from 16.0 to 15.8 points); the between-group difference in the mean change was 8.3 points (95% confidence interval [CI], 5.9 to 10.7; P<0.001). The improvement in the thalamotomy group was maintained at 12 months (change from baseline, 7.2 points; 95% CI, 6.1 to 8.3). Secondary outcome measures assessing disability and quality of life also improved with active treatment (the blinded thalamotomy cohort)as compared with the sham procedure (P<0.001 for both comparisons). Adverse events in the thalamotomy group included gait disturbance in 36% of patients and paresthesias or numbness in 38%; these adverse events persisted at 12 months in 9% and 14% of patients, respectively. Conclusions: MRI-guided focused ultrasound thalamotomy reduced hand tremor in patients with essential tremor. Side effects included sensory and gait disturbances. (Funded by InSightec and others; ClinicalTrials.gov number, NCT01827904.).
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1. College of Medicine (의과대학) > Dept. of Neurosurgery (신경외과학교실) > 1. Journal Papers
Yonsei Authors
Lee, Won Hee(이원희)
Chang, Jin Woo(장진우) ORCID logo https://orcid.org/0000-0002-2717-0101
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