A groundbreaking trial might change the game for many older adults grappling with a condition that's been under the radar. Johns Hopkins University School of Medicine, in collaboration with the University of Utah and other institutions, led an international study on the effects of shunt surgery in patients with idiopathic normal pressure hydrocephalus (iNPH). According to At The U, the disorder, which affects up to 1.5% of people in their late 60s and as many as one in 13 over age 86, leads to walking and balance issues, memory decline, and bladder control woes.
The study's results were promising enough to cut the trial short. The Placebo-Controlled Effectiveness in iNPH Shunting (PENS) Trial, which is the first of its kind, used a double-blind, placebo-controlled methodology to properly gauge the effectiveness of shunt surgery. Richard Holubkov, senior author and University of Utah faculty, stated, "The findings favoring the effectiveness of shunting were so compelling that the independent board reviewing the trial stopped it early and directed all participants with the ‘placebo’ shunts to immediately have them opened," as per At The U. The trial saw 99 participants across 17 centers undergo a shunt surgery, half of which were initially set to a placebo setting blocking drainage.
Further results indicated considerable improvements in walking speeds for patients with functioning shunts, as detailed in The New England Journal of Medicine on September 16. Mark Luciano, the principal investigator and director of the Cerebral Fluid Center at Johns Hopkins, addressed past skepticism: "Although shunts have been used for 50 years, skepticism persisted because of the powerful placebo effect and the risks of operating in frail, elderly patients," Luciano explained, as obtained by At The U. "This study shows surgery is both effective, and has an acceptable safety profile. We've proven this treatment works, definitively, and safely, in the most rigorous type of study possible."
Participants with the real deal improved by an average of 0.23 meters per second in walking speed, a significant jump, considering the threshold for meaningful change in older adults is less than half that. An impressive 80% of these patients experienced meaningful improvement. Balance and stability gained ground, too, with the treatment group reporting fewer falls. "Forty-six percent of patients in the placebo group reported falling during the trial, compared with just 25% of those who received a functioning shunt," according to At The U.
