Adjustable shunt treatment for idiopathic normal pressure hydrocephalus (iNPH)
A Placebo-Controlled Effectiveness in INPH Shunting (PENS) Trial
This project compares active versus 'virtual-off' settings of an adjustable brain shunt to see if shunting improves walking and thinking 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 ID | NIH-11416159 on NIH RePORTER |
What this research studies
You would receive the same FDA-approved adjustable ventriculoperitoneal shunt surgery as everyone else in the study, but the valve will be set either to a functioning or a non-functioning ('virtual-off') position at first. You and your care team will be blinded to that initial setting, and your walking speed, balance, and related function will be measured with the main comparison at three months. The trial plans to enroll about 100 people across roughly 20 sites and selects participants using standard iNPH clinical guidelines. If your valve is initially set to 'virtual-off', the setting can be changed later so you can still get active treatment.
Who could benefit from this research
Good fit: Adults diagnosed with idiopathic normal pressure hydrocephalus—typically older adults with gait disturbance, cognitive changes, and imaging consistent with iNPH—who are considered eligible for shunt surgery under standard guidelines.
Not a fit: People without iNPH, those who are not surgical candidates, or those whose symptoms are due to other advanced neurologic or medical conditions are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this could confirm that shunting reliably improves gait and cognition in iNPH and make the surgery more widely accepted and available.
How similar studies have performed: Previous non-randomized and observational studies have suggested benefit from shunting, but there has not been a large, placebo-controlled trial providing a definitive answer until now.
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.