Placebo-controlled shunting for iNPH: does the surgery help with walking and balance?
Official title: A Placebo-Controlled Effectiveness in INPH Shunting (PENS) Trial
Funded at Johns Hopkins University · NIH-11628947 · Data updated 2026-11-12
A doctor-led trial at Johns Hopkins will test whether a shunt surgery improves walking and balance in older adults with idiopathic normal pressure hydrocephalus.
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 start | September 30, 2021 |
| Project end | July 31, 2027 |
| Funding year | 2026 |
| Award (this year) | $30,002 |
| NIH project number | 3U01NS122764-05S1 |
| Project ID | NIH-11628947 on NIH RePORTER |
Who could benefit from this research
✓Could help
Ideal candidates are adults with a clinical diagnosis of iNPH who meet standard guidelines and are eligible for VPS.
✕Less likely to help
Some participants may not experience improvement in gait or balance.
What this research studies
This trial enrolls 100 adults with iNPH at 20 sites to receive a shunt device that can be toggled between active and placebo-like settings. Participants are randomly assigned to start with the active or placebo valve, then all receive the same surgery and device. The main goal is to see if shunt surgery improves gait velocity after three months, with secondary measures of balance and other related outcomes. The study uses a blinded, controlled design so results reflect true effects of the intervention.
Why it matters
Potential benefit: If successful, the trial could clarify whether VPS improves walking and daily function for people with iNPH.
How similar studies have gone: This approach builds on longstanding VPS use, but this trial provides rigorous placebo-controlled data to confirm benefit.
Where this research is happening
-
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.