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

Placebo-Controlled Efficacy in iNPH Shunting (PENS) is a trial interested in assessing the effectiveness of surgical cerebrospinal fluid shunting for idiopathic normal pressure hydrocephalus (iNPH) treatment. iNPH was first described in the 1960s as a form of dementia that can be reversed with ventriculoperitoneal shunting (a surgical treatment). 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. 

ClinicalTrials.gov Identifier: NCT05081128 

For more information, please contact one of the participating clinical sites in the map below.