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Placebo-Controlled Trial Confirms Shunt Surgery Improves Mobility in iNPH

The NEJM report provides blinded, placebo-controlled evidence that adjustable brain shunts are effective for idiopathic normal-pressure hydrocephalus.

Overview

  • In the multicenter PENS study, all participants received implanted, magnetically adjustable valves that were randomized to open or closed in a double-blind design across sites in the U.S., Canada and Sweden.
  • Patients with activated shunts increased gait speed by more than 0.2 meters per second on average, with 80% surpassing the 0.1 m/s threshold for a clinically meaningful gain.
  • Those with closed valves showed no improvement in gait and reported more falls, while treated participants reported better quality of life and everyday functioning.
  • University releases report the randomized phase was halted early for efficacy, after which placebo-group valves were turned on, with ongoing follow-up assessing durability, cognition, imaging correlates and safety.
  • Investigators note that iNPH is common yet under-recognized in older adults, with estimated prevalence of about 1.5% in the 70s and up to roughly 7–7.7% in the 80s, and relatively few diagnosed patients receiving shunt treatment.