Active Clinical Trials

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

PENS is a trial interested in 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 will use 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 will use 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.

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.