On July 3, 2025, the US Food and Drug Administration approved staged, bilateral focused ultrasound pallidothalamic tractotomy for advanced Parkinson's disease with medication-refractory motor complications, on the basis of results from a then-unpublished single-arm trial.1 We cautioned then that a symmetrical lesioning procedure was being licensed ahead of its evidence.2 The results presented by Arif Dalvi and colleagues1 support that caution was warranted: modest gains in off-medication motor scores after treatment of the second side (a 19% improvement over the plateau reached after unilateral treatment) were accompanied by persistent moderate or severe adverse events at 12 months in ten (25%) of the 40 bilaterally treated patients, one of whom had severe persistent anarthria.
Source: The Lancet Neurology - Current Issue
·Published 31 Oct 2026 ·Imported 17 Oct 2026
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