Research overview
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ObjectiveTo present the secondary endpoints at one-year blinded follow-up from our randomized controlled study, that compared the efficacy of DBS in the ventral-intermediate thalamic nucleus (VIM) with the posterior subthalamic area (PSA) three months each in crossover design, and showed significantly greater reduction of the Sum dominant arm tremor score (Fahn-Tolosa-Marin) during the PSA-DBS period. The outcomes at one year are now reported to verify target choice and sustained benefit with clinically optimized free programming.MethodsForty-five patients with isolated or combined arm action tremor received four-level DBS leads to reach both VIM (upper two levels) and PSA (lower two), and were randomized post-operatively to VIM-DBS month 1-3 followed by PSA-DBS month 4-6, or vice versa. Thereafter electrode choice was free as judged by best clinical outcome. Predefined secondary endpoints were the tremor score improvements from preoperative to the one-year follow-up for dominant and non-dominant arm, other body regions, total score, two patient-rated measures and adverse events.ResultsAt the one-year follow-up, Sum dominant arm tremor scores had improved from median 24 at baseline to 4 (pInterpretationAt one year, good and sustained tremor suppression from PSA-DBS was confirmed in ET, PD and Dystonic tremor. Suppression of Cerebellar tremor was more variable.Trial registrationNCT03156517, May 29, 2017.
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