Clinical Trials

PENS Trial (No Longer Recruiting)

Placebo-Controlled Efficacy in Idiopathic Normal Pressure Hydrocephalus (iNPH) Shunting (PENS) Trial

The enrollment for this trial has been closed.

PENS is a clinical trial assessing the effectiveness of surgical cerebrospinal fluid shunting for iNPH treatment. iNPH was first described in the 1960s as a form of dementia that can be reversed with ventriculoperitoneal shunting. This trial uses surgical cerebrospinal fluid shunting, which involves inserting a hollow tube to drain excess cerebrospinal fluid and redirect it into another part of the body to be absorbed.

This trial uses an FDA-approved adjustable shunt system. The shunt includes a “virtual off” setting that allows for noninvasive assignment of patients to either an active group or a placebo group. The trial has a delayed treatment design where all patients, regardless of assigned group, will be treated with shunting after the 3-month comparative period.

PENS Trial is a multi-institutional, randomized, double-blinded, placebo-controlled clinical trial. This trial is funded by the NINDS and will have 20 participating academic hospitals in the United States, Canada, and Sweden.

Initial findings from the study have been published: https://www.nejm.org/doi/10.1056/NEJMoa2503109.

For more information, visit: penstrial.org or ClinicalTrials.gov Identifier NCT05081128.

Also, check out the Hydrocephalus Association’s blog post, highlighting the grant funding awarded for this trial.