Overview
- In the randomized, double-blind, placebo-controlled PENS trial, 99 patients across 21 centers in the U.S., Canada, and Sweden received adjustable shunts and were assigned to valves turned on or off.
- Participants with activated valves increased gait speed by more than 0.2 meters per second, with 80% surpassing the clinically meaningful threshold, while the placebo group showed no improvement.
- Patients with functioning shunts reported fewer falls, better balance, and improved quality of life after three months, and investigators described the safety profile as acceptable.
- An institutional release reported the study was halted early for efficacy; placebo-group valves have since been activated and longer-term follow-up is assessing durability, cognition, and MRI correlations.
- iNPH affects an estimated 1.5% of people in their 70s and up to about 7–7.7% in their 80s, and the trial was supported by NINDS and the NIH Trial Innovation Network.