• Keiichi Abe, Shiro Horisawa, Toshio Yamaguchi, Hiroki Hori, Kazumichi Yamada, Kimito Kondo, Hironori Furukawa, Hajime Kamada, Haruhiko Kishima, Satoru Oshino, Hideki Mochizuki, Manabu Kanemoto, Hidehiro Hirabayashi, Kenji Fukutome, Hideyuki Ohnishi, Keiji Igase, Ichiro Matsubara, Takanori Ohnishi, Kazuhiko Sadamoto, and Takaomi Taira.
• Department of Neurosurgery, Tokyo Women's Medical University, Tokyo, Japan.
• Neurosurgery. 2021 Mar 15; 88 (4): 751-757.

BackgroundSeveral feasibility studies and a randomized, controlled, multicenter trial have demonstrated the safety and efficacy of unilateral transcranial magnetic resonance-guided focused ultrasound (FUS) lesioning of the ventral intermediate thalamic nucleus in treating essential tremor.ObjectiveTo evaluate the safety and efficacy of FUS thalamotomy in a Japanese patient cohort through a prospective, multicenter, single-arm confirmatory trial.MethodsA total of 35 patients with disabling refractory essential tremor underwent unilateral FUS thalamotomy and were followed up for 12 post-treatment months. Safety was measured as the incidence and severity of treatment-related adverse events. Efficacy was measured as the tremor severity and quality of life improvements using the Clinical Rating Scale for Tremor and Questionnaire for Essential Tremor.ResultsThe mean skull density ratio (SDR) was 0.47. There was a significant decrease in the mean postural tremor score of the treated hand from baseline to 12 mo by 56.4% (95% CI: 46.7%-66.1%; P < .001), which was maintained at last follow-up. Quality of life improved by 46.3% (mean overall Questionnaire for Essential Tremor score of 17.4 [95% CI: 12.1-22.7]) and there were no severe adverse events. The most frequent adverse event was gait disturbance and all events resolved.ConclusionUnilateral FUS thalamotomy allowed significant and sustained tremor relief and improved the quality of life with an outstanding safety profile. The observed safety and efficacy of FUS thalamotomy were comparable to those reported in a previous multicenter study with a low SDR, and inclusion of the low SDR group did not affect effectiveness.© Congress of Neurological Surgeons 2021.

29 keywords...

hide…