Patients with idiopathic Normal Pressure Hydrocephalus (iNPH) face many obstacles to getting diagnosed and treated. This study was created to help remove obstacles for patients like you or your loved one.

In this research study, researchers are studying how well cerebrospinal fluid (CSF) shunt systems work in decreasing the symptoms of hydrocephalus. Participants will have a CSF shunt system placed by a neurosurgeon. During the surgery, the shunt will be set to “open” or “closed,” and it will remain on this setting for the evaluation period, which lasts three months. The shunt setting each participant gets is decided by chance (like flipping a coin). You will not know which setting you were assigned until the end of the study. At the end of three months, the setting will be set to “open” for all participants. Your neurosurgeon will work with you to determine how to best use the shunt to manage your hydrocephalus moving forward.

Study Overview

• Study name: The Placebo-controlled Efficacy of iNPH Shunting (PENS) Trial
• Study ID: NCT05081128
• Principal investigator: Mark Luciano, MD, PhD
• Study duration: About 12-15 months
• Eligibility criteria: adults aged 60 and older who have idiopathic (unknown
  cause) Normal Pressure Hydrocephalus (iNPH) and plan to have a shunt placed
• Clinic location: Levi Watkins, Jr., M.D., Outpatient Center in Baltimore, MD
  • View additional study centers in the US
• Total participants: 100
• Compensation: up to $200
• How to participate: please contact Kallan Dirmeyer at [email protected] or 410-449-0093.
• Learn more on ClinicalTrials.gov

What to Expect if You Join

Once you are accepted into the study, you will have an appointment to complete the following tests before receiving a shunt:

• Walking speed and balance
• Neurocognitive assessments and functional tests

This testing will take about 40 minutes. You will also have the following tests that may happen on a different day if you prefer:

• Research MRI (about 1 hour) to see how your brain changes before and after shunting
• Neuropsychological testing (about 2 hours) with a neuropsychologist

Once you are cleared for surgery, a Johns Hopkins neurosurgeon will place a shunt as a standard of care inpatient surgery. After your surgery, you will return to the clinic for standard follow-up visits at the following times:

• 1-month post-op
• 3-months post-op
• 6-months post-op
• 9-months post-op
• 12-15 months pos-op

You will repeat the following tests at each visit:

• Walking speed and balance
• Neurocognitive assessments and functional tests

At the 3-month visit after surgery and your last visit (12-15 months after surgery), you will repeat the following tests:

• Research MRI (about 1 hour) to see how your brain changes before and after
  shunting
• Neuropsychological testing (about 2 hours) with a neuropsychologist

Who Can Participate

A participant must meet all three criteria:

• Adults age 60 or older
• Newly diagnosed (no prior shunt) with idiopathic normal pressure hydrocephalus (iNPH)
• Referred for shunt surgery to treat their iNPH (contact <name> at <email> to learn how to schedule a consultation)

View additional eligibility criteria. This study is not recruiting healthy volunteers.

Benefits and Risks

We cannot guarantee any benefits as a result of taking part in this research study. The risks of this study are similar to the risks of having shunt surgery. Your study doctor will discuss the risks associated with taking part in this study.