Shunt treatment versus placebo for normal pressure hydrocephalus
A Placebo-Controlled Effectiveness in INPH Shunting (PENS) Trial
Older adults with idiopathic normal pressure hydrocephalus will get a brain shunt set to work or set to a non-working 'virtual off' position to see whether walking and thinking improve.
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-11194244 on NIH RePORTER |
What this research studies
If you have iNPH and are chosen for the trial, you will receive the same shunt surgery as everyone, but the valve will be programmed either to allow fluid drainage (active) or to a non-functioning 'virtual off' setting (placebo) without extra surgery. You will be randomly assigned and blinded so you and most study staff won't know the initial valve setting, and after three months the valve can be adjusted for all participants. The study plans to enroll about 100 patients across roughly 20 clinical sites and will measure walking speed at three months as the main outcome, with balance and cognitive tests as secondary outcomes.
Who could benefit from this research
Good fit: Adults (typically older) diagnosed with idiopathic normal pressure hydrocephalus who are being considered for ventriculoperitoneal shunt surgery and meet standard iNPH guidelines.
Not a fit: People whose walking or cognitive problems are due to other causes (for example advanced Alzheimer's disease, stroke, or other medical conditions) or who do not meet iNPH criteria may not receive benefit from the shunt.
Why it matters
Potential benefit: If successful, this trial could confirm that shunting reliably improves gait, balance, and thinking in iNPH and make the surgery more widely accepted.
How similar studies have performed: Shunting has been used for decades with many observational reports of improvement, but this is one of the first large randomized, placebo-controlled trials aiming to provide definitive evidence.
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.