Shunt surgery to improve walking and thinking in normal pressure hydrocephalus
A Placebo-Controlled Effectiveness in INPH Shunting (PENS) Trial
This project compares functioning versus temporarily turned-off adjustable brain shunts to help adults with iNPH improve walking and thinking.
Quick facts
| Grant type | U01 cooperative agreement |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Johns Hopkins University NIH-funded |
| Lab location | 1 site (Baltimore, United States) |
| Project ID | NIH-11416160 on NIH RePORTER |
What this research studies
I have idiopathic normal pressure hydrocephalus (iNPH), which can cause slow walking and memory problems. Everyone in the trial gets the same FDA-approved adjustable ventriculoperitoneal shunt, but some people have the valve set to work right away while others have it set to a non-working 'virtual off' position that can be changed later without more surgery. The trial is randomized and blinded and will measure change in walking speed at three months as the main outcome, with additional tests of balance and thinking. About 100 patients will be enrolled across 20 sites and all participants will eventually have the device active.
Who could benefit from this research
Good fit: Adults (21+) diagnosed with idiopathic normal pressure hydrocephalus who are considered candidates for ventriculoperitoneal shunt surgery under standard iNPH guidelines.
Not a fit: People without iNPH, those with other causes of gait or cognitive problems, or those who are not safe surgical candidates are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this could confirm that shunt surgery improves walking and thinking for people with iNPH and could broaden access to this treatment.
How similar studies have performed: Shunting has decades of observational support for helping iNPH patients, but this is among the first large randomized, placebo-controlled trials to test that benefit rigorously.
Where this research is happening
Baltimore, United States
- Johns Hopkins University — Baltimore, United States (Active)
Researchers
- Principal investigator: Luciano, Mark Gregory — Johns Hopkins University
- Study coordinator: Luciano, Mark Gregory
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.