Investigating the effectiveness of shunt surgery for treating dementia and gait issues in the elderly
A Placebo-Controlled Effectiveness in INPH Shunting (PENS) Trial
This study is looking at whether a specific surgery can help older adults with Idiopathic Normal Pressure Hydrocephalus (iNPH) improve their memory and walking, and it will involve 100 participants who will either receive the surgery or a placebo to see how well it works.
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-10700923 on NIH RePORTER |
What this research studies
This research focuses on Idiopathic Normal Pressure Hydrocephalus (iNPH), a condition that can cause reversible dementia and gait imbalance in older adults. The study aims to determine the effectiveness of surgical ventriculoperitoneal shunting (VPS) through a randomized, placebo-controlled trial. Participants will be randomly assigned to receive either an active or a placebo shunt, allowing researchers to assess the true benefits of the surgery. The trial will involve 100 patients across 20 sites, with outcomes measured primarily by changes in gait velocity after three months.
Who could benefit from this research
Good fit: Ideal candidates for this research are elderly patients diagnosed with Idiopathic Normal Pressure Hydrocephalus who meet standard treatment guidelines.
Not a fit: Patients with other forms of dementia or those who do not meet the criteria for iNPH may not benefit from this research.
Why it matters
Potential benefit: If successful, this research could provide definitive evidence on the benefits of shunt surgery for patients with iNPH, potentially improving treatment options for this condition.
How similar studies have performed: Previous research has shown that similar placebo-controlled trials can provide valuable insights into treatment effectiveness, but this specific approach for iNPH is novel.
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.