Placebo-Controlled Efficacy in Idiopathic Normal Pressure Hydrocephalus Shunting
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 noninvasive 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.
Led by principal investigator Mark Luciano, MD, PhD, director of the Cerebral Fluid Center and professor in the Johns Hopkins University (JHU) Department of Neurosurgery, the PENS Trial will have 20 participating academic hospitals in the United States, Canada, and Sweden. BIOS CTCC, which is also the JHU-Tufts Trial Innovation Center, serves as the clinical coordinating center, and the University of Utah serves as the data coordinating center. The trial is supported by the Adult Hydrocephalus Clinical Research Network, the Hydrocephalus Association, and the NIH National Center for Advancing Translational Sciences Trial Innovation Network.
ClinicalTrials.gov Identifier: NCT05081128