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.
journal_name
Neurologyjournal_title
Neurologyauthors
Halpern CH,Santini V,Lipsman N,Lozano AM,Schwartz ML,Shah BB,Elias WJ,Cosgrove GR,Hayes MT,McDannold N,Aldrich C,Eisenberg HM,Gandhi D,Taira T,Gwinn R,Ro S,Witt J,Jung NY,Chang JW,Rosenberg J,Ghanouni Pdoi
10.1212/WNL.0000000000008561subject
Has Abstractpub_date
2019-12-10 00:00:00pages
e2284-e2293issue
24eissn
0028-3878issn
1526-632Xpii
WNL.0000000000008561journal_volume
93pub_type
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