Casey H Halpern1, Veronica Santini2, Nir Lipsman2, Andres M Lozano2, Michael L Schwartz2, Binit B Shah2, W Jeff Elias2, Garth R Cosgrove2, Michael T Hayes2, Nathan McDannold2, Christina Aldrich2, Howard M Eisenberg2, Dheeraj Gandhi2, Takaomi Taira2, Ryder Gwinn2, Susie Ro2, Jennifer Witt2, Na Young Jung2, Jin Woo Chang2, Jarrett Rosenberg2, Pejman Ghanouni1. 1. From the Departments of Neurosurgery (C.H.H.), Neurology (V.S.), and Radiology (J.R., P.G.), Stanford University School of Medicine, CA; Department of Neurosurgery (N.L., A.M.L., M.L.S.), University of Toronto, Canada; Department of Neurology (B.B.S., W.J.E.), University of Virginia, Charlottesville; Departments of Neurosurgery (G.R.C.), Neurology (M.T.H.), and Radiology (N.M.), Brigham and Women's Hospital, Boston, MA; Departments of Neurosurgery (C.A., H.M.E.) and Radiology (D.G.), University of Maryland, Baltimore; Department of Neurosurgery (T.T.), Tokyo Women's Medical University, Japan; Departments of Neurosurgery (R.G.) and Neurology (S.R., J.W.), Swedish Hospital Seattle, WA; and Department of Neurosurgery (N.Y.J., J.W.C.), Yonsei University, Seoul, Republic of Korea. chalpern@stanford.edu ghanouni@stanford.edu. 2. From the Departments of Neurosurgery (C.H.H.), Neurology (V.S.), and Radiology (J.R., P.G.), Stanford University School of Medicine, CA; Department of Neurosurgery (N.L., A.M.L., M.L.S.), University of Toronto, Canada; Department of Neurology (B.B.S., W.J.E.), University of Virginia, Charlottesville; Departments of Neurosurgery (G.R.C.), Neurology (M.T.H.), and Radiology (N.M.), Brigham and Women's Hospital, Boston, MA; Departments of Neurosurgery (C.A., H.M.E.) and Radiology (D.G.), University of Maryland, Baltimore; Department of Neurosurgery (T.T.), Tokyo Women's Medical University, Japan; Departments of Neurosurgery (R.G.) and Neurology (S.R., J.W.), Swedish Hospital Seattle, WA; and Department of Neurosurgery (N.Y.J., J.W.C.), Yonsei University, Seoul, Republic of Korea.
Abstract
OBJECTIVE: To test the hypothesis that transcranial magnetic resonance-guided focused ultrasound (tcMRgFUS) thalamotomy is effective, durable, and safe for patients with medication-refractory essential tremor (ET), we assessed clinical outcomes at 3-year follow-up of a controlled multicenter prospective trial. METHODS: Outcomes were based on the Clinical Rating Scale for Tremor, including hand combined tremor-motor (scale of 0-32), functional disability (scale of 0-32), and postural tremor (scale of 0-4) scores, and total scores from the Quality of Life in Essential Tremor Questionnaire (scale of 0-100). Scores at 36 months were compared with baseline and at 6 months after treatment to assess for efficacy and durability. Adverse events were also reported. RESULTS: Measured scores remained improved from baseline to 36 months (all p < 0.0001). Range of improvement from baseline was 38%-50% in hand tremor, 43%-56% in disability, 50%-75% in postural tremor, and 27%-42% in quality of life. When compared to scores at 6 months, median scores increased for hand tremor (95% confidence interval [CI] 0-2, p = 0.0098) and disability (95% CI 1-4, p = 0.0001). During the third follow-up year, all previously noted adverse events remained mild or moderate, none worsened, 2 resolved, and no new adverse events occurred. CONCLUSIONS: Results at 3 years after unilateral tcMRgFUS thalamotomy for ET show continued benefit, and no progressive or delayed complications. Patients may experience mild degradation in some treatment metrics by 3 years, though improvement from baseline remains significant. CLINICALTRIALSGOV IDENTIFIER: NCT01827904. CLASSIFICATION OF EVIDENCE: This study provides Class IV evidence that for patients with severe ET, unilateral tcMRgFUS thalamotomy provides durable benefit after 3 years.
RCT Entities:
OBJECTIVE: To test the hypothesis that transcranial magnetic resonance-guided focused ultrasound (tcMRgFUS) thalamotomy is effective, durable, and safe for patients with medication-refractory essential tremor (ET), we assessed clinical outcomes at 3-year follow-up of a controlled multicenter prospective trial. METHODS: Outcomes were based on the Clinical Rating Scale for Tremor, including hand combined tremor-motor (scale of 0-32), functional disability (scale of 0-32), and postural tremor (scale of 0-4) scores, and total scores from the Quality of Life in Essential Tremor Questionnaire (scale of 0-100). Scores at 36 months were compared with baseline and at 6 months after treatment to assess for efficacy and durability. Adverse events were also reported. RESULTS: Measured scores remained improved from baseline to 36 months (all p < 0.0001). Range of improvement from baseline was 38%-50% in hand tremor, 43%-56% in disability, 50%-75% in postural tremor, and 27%-42% in quality of life. When compared to scores at 6 months, median scores increased for hand tremor (95% confidence interval [CI] 0-2, p = 0.0098) and disability (95% CI 1-4, p = 0.0001). During the third follow-up year, all previously noted adverse events remained mild or moderate, none worsened, 2 resolved, and no new adverse events occurred. CONCLUSIONS: Results at 3 years after unilateral tcMRgFUS thalamotomy for ET show continued benefit, and no progressive or delayed complications. Patients may experience mild degradation in some treatment metrics by 3 years, though improvement from baseline remains significant. CLINICALTRIALSGOV IDENTIFIER: NCT01827904. CLASSIFICATION OF EVIDENCE: This study provides Class IV evidence that for patients with severe ET, unilateral tcMRgFUS thalamotomy provides durable benefit after 3 years.
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