PT  - JOURNAL ARTICLE
AU  - Halpern, Casey H.
AU  - Santini, Veronica
AU  - Lipsman, Nir
AU  - Lozano, Andres M.
AU  - Schwartz, Michael L.
AU  - Shah, Binit B.
AU  - Elias, W. Jeff
AU  - Cosgrove, Garth R.
AU  - Hayes, Michael T.
AU  - McDannold, Nathan
AU  - Aldrich, Christina
AU  - Eisenberg, Howard M.
AU  - Gandhi, Dheeraj
AU  - Taira, Takaomi
AU  - Gwinn, Ryder
AU  - Ro, Susie
AU  - Witt, Jennifer
AU  - Jung, Na Young
AU  - Chang, Jin Woo
AU  - Rosenberg, Jarrett
AU  - Ghanouni, Pejman
TI  - Three-year follow-up of prospective trial of focused ultrasound thalamotomy for essential tremor
AID  - 10.1212/WNL.0000000000008561
DP  - 2019 Dec 10
TA  - Neurology
PG  - e2284--e2293
VI  - 93
IP  - 24
4099  - http://n.neurology.org/content/93/24/e2284.short
4100  - http://n.neurology.org/content/93/24/e2284.full
SO  - Neurology2019 Dec 10; 93
AB  - 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.Clinicaltrials.gov 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.AE=adverse event; CI=confidence interval; CRST=Clinical Rating Scale for Tremor; DBS=deep brain stimulation; ET=essential tremor; FDA=Food and Drug Administration; IQR=interquartile range; MR=magnetic resonance; PMA=premarket approval; QOL=quality of life; QUEST=Quality of Life in Essential Tremor Questionnaire; RCT=randomized controlled trial; tcMRgFUS=transcranial magnetic resonance–guided focused ultrasound; Vim=ventral intermediate nucleus