Shunt surgery to improve walking and thinking in older adults with normal pressure hydrocephalus
A Placebo-Controlled Effectiveness in INPH Shunting (PENS) Trial
This study compares active versus inactive adjustable brain shunts to see if turning the shunt on helps older adults with idiopathic normal pressure hydrocephalus walk and think better.
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-11416161 on NIH RePORTER |
What this research studies
You would receive a standard adjustable ventriculoperitoneal shunt, but the valve will be set either to work right away or to a non‑functioning (virtual off) setting so neither you nor the evaluators know which you received. Everyone gets the same surgery and device, and patients are randomly assigned to the active or placebo valve setting in a blinded way. Researchers will measure walking speed and balance, plus cognitive changes, with the primary outcome being gait velocity three months after surgery. The trial plans to enroll 100 people across about 20 sites using widely accepted iNPH selection guidelines.
Who could benefit from this research
Good fit: Adults meeting standard clinical criteria for idiopathic normal pressure hydrocephalus with gait disturbance and who are considered surgical candidates would be ideal for this trial.
Not a fit: People whose gait or dementia is primarily due to other diagnoses (for example advanced Alzheimer disease, Parkinson disease, or vascular dementia) or who do not meet surgical criteria are less likely to benefit from this procedure.
Why it matters
Potential benefit: If successful, this could confirm that shunt surgery reliably improves walking and thinking in people with iNPH and support broader, evidence-based use of the procedure.
How similar studies have performed: Observational and non‑randomized studies have suggested shunting can help symptoms of iNPH, but well-controlled placebo‑blinded randomized evidence has been lacking 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.