MedTrace Logo

Efficacy in iNPH Shunting (PENS) Trial

NCT05081128 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-05-08

No results posted yet for this study

Summary

The Placebo-Controlled Efficacy in Idiopathic Normal Pressure Hydrocephalus (iNPH) Shunting (PENS) trial is a multi-center blinded, randomized, placebo-controlled design investigation of cerebrospinal fluid (CSF) shunt surgery to study the shunt efficacy in iNPH patients.

Conditions

  • Idiopathic Normal Pressure Hydrocephalus (INPH)

Interventions

DEVICE

programmable CSF shunt valve

Brain shunt surgery using a programmable CSF shunt valve

Sponsors & Collaborators

Principal Investigators

  • Mark Luciano, MD, PhD · Johns Hopkins University

  • Richard Holubkov, PhD · University of Utah

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-18
Primary Completion
2027-05-31
Completion
2027-08-31
FDA Device
Yes

Countries

  • United States
  • Canada
  • Sweden

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05081128 on ClinicalTrials.gov