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Neurology. 2019 Dec 10;93(24):e2284-e2293. doi: 10.1212/WNL.0000000000008561. Epub 2019 Nov 20.

Three-year follow-up of prospective trial of focused ultrasound thalamotomy for essential tremor.

Author information

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.

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