Overview

• Investigators enrolled 99 patients at 17 sites in the U.S., Canada and Sweden, using programmable shunts randomized on versus off in a double-blind design.
• Patients with activated shunts increased gait speed by more than 0.2 m/s, with 80% achieving clinically meaningful improvement, while the placebo group showed no gain.
• Those with active shunts reported fewer falls and better scores for daily function and quality of life than participants with inactive devices.
• Study leaders reported an acceptable safety profile; early analyses found trends in cognition and bladder control that did not reach statistical significance.
• At the end of the blinded phase, placebo-group shunts were turned on, and ongoing follow-up will track durability, detailed neuropsychological outcomes and MRI correlations.