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This two-center, randomized, sham-controlled, manufacturer-supported pilot study tested whether unilateral focused ultrasound thalamotomy was safe and effective for the treatment of tremor in tremor-dominant Parkinson disease (PD). Investigators randomized 27 patients 2:1 to thalamotomy or sham thalamotomy. The primary outcome was change in on-medication hand tremor, measured using the Clinical Rating Scale for Tremor A + B. Blinded follow-up occurred at 3 months, followed by a 1-year open-label phase.
At 3 months, the thalamotomy group had a 62% improvement on the primary outcome versus a 22% improvement in the sham group. One-year, open-label follow-up was limited by the loss of six (30%) actively treated patients to follow-up. In an inten…