A Placebo-controlled Effectiveness in iNPH Shunting (PENS) Trial
Placebo-Controlled Efficacy in iNPH Shunting (PENS) is a multi-institutional, randomized, double-blinded, placebo-controlled clinical trial funded by the National Institute of Neurological Disorders and Stroke.
PENS is assessing the effectiveness of surgical cerebrospinal fluid shunting for idiopathic normal pressure hydrocephalus (iNPH) treatment. This trial will use surgical cerebrospinal fluid shunting, which involves inserting a hollow tube into the brain 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 non-invasive assignment of patients to either an active group or a control group. The trial has a delayed treatment design in which all patients, regardless of original group assignment, will be treated with shunting after the 3-month comparative period.
Our Role in PENS Trial
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Our lab is the Biomarker Core for the study. We will be analyzing CSF from approximately 300 study subjects from the 20 participating sites and analyzing biomarkers that distinguish NPH from other neurodegenerative disorders and more importantly predict who has a sustained response to shunt implantation 1 year later.